Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

May 8, 2026 updated by: AstraZeneca

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Australia, 3128
        • Research Site
      • Gosford, Australia, 2250
        • Research Site
      • Kogarah, Australia, 2217
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
      • Port Macquarie, Australia, 2444
        • Research Site
      • Southport, Australia, 4215
        • Research Site
      • St Leonards, Australia, 2065
        • Research Site
  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Charleroi, Belgium, 6000
        • Research Site
      • Duffel, Belgium, 2570
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
  • Canada
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Research Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Research Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Research Site
      • Saint Catherines, Ontario, Canada, L2R 6P9
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6A 0A8
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Research Site
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Research Site
  • France
      • Bordeaux, France, 33000
        • Research Site
      • Brest, France, 29609
        • Research Site
      • Créteil, France, 94010
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Lyon, France, 69373
        • Research Site
      • Marseille, France, 13915
        • Research Site
  • Germany
      • Aachen, Germany, 52074
        • Research Site
      • Bad Berka, Germany, 99437
        • Research Site
      • Berlin, Germany, 12351
        • Research Site
      • Berlin, Germany, 10967
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Research Site
      • Gauting, Germany, 82131
        • Research Site
      • Hamburg, Germany, 20251
        • Research Site
      • Heidelberg, Germany, 69126
        • Research Site
      • Hemer, Germany, 58675
        • Research Site
      • Homburg/Saar, Germany, 66421
        • Research Site
      • Immenhausen, Germany, 34376
        • Research Site
      • Löwenstein, Germany, 74245
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Oldenburg, Germany, 26121
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
      • Velbert, Germany, 42551
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Deszk, Hungary, 6772
        • Research Site
      • Edelény, Hungary, 3780
        • Research Site
      • Kaposvár, Hungary, 7400
        • Research Site
      • Kecskemét, Hungary, 6000
        • Research Site
      • Miskolc, Hungary, 3529
        • Research Site
      • Nyíregyháza, Hungary, 4400
        • Research Site
      • Pécs, Hungary, 7624
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Research Site
  • Italy
      • Genova, Italy, 16100
        • Research Site
      • Meldola, Italy, 47014
        • Research Site
      • Milan, Italy, 20141
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Milan, Italy, 20133
        • Research Site
      • San Giovanni Rotondo, Italy, 71013
        • Research Site
      • Siena, Italy, 53100
        • Research Site
  • Japan
      • Fukushima, Japan, 960-1295
        • Research Site
      • Himeji-shi, Japan, 670-8520
        • Research Site
      • Hirakata-shi, Japan, 573-1191
        • Research Site
      • Hirosaki-shi, Japan, 036-8545
        • Research Site
      • Iizuka-shi, Japan, 820-8505
        • Research Site
      • Iwakuni-shi, Japan, 740-8510
        • Research Site
      • Izumi-shi, Japan, 594-0073
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Research Site
      • Kishiwada-shi, Japan, 596-8501
        • Research Site
      • Kobe, Japan, 650-0047
        • Research Site
      • Koga-shi, Japan, 811-3195
        • Research Site
      • Kyoto, Japan, 615-8256
        • Research Site
      • Kyoto, Japan, 607-8062
        • Research Site
      • Mitaka-shi, Japan, 181-8611
        • Research Site
      • Nagaoka-shi, Japan, 940-2085
        • Research Site
      • Nagoya, Japan, 466-8560
        • Research Site
      • Nagoya, Japan, 460-0001
        • Research Site
      • Okayama, Japan, 700-8607
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Osaka, Japan, 543-0035
        • Research Site
      • Saga, Japan, 840-8571
        • Research Site
      • Saitama-shi, Japan, 336-8522
        • Research Site
      • Sakaishi, Japan, 591-8555
        • Research Site
      • Sayama, Japan, 589-8511
        • Research Site
      • Sendai, Japan, 980-0873
        • Research Site
      • Shinjuku-ku, Japan, 162-8655
        • Research Site
      • Tokushima, Japan, 770-8503
        • Research Site
      • Ube-shi, Japan, 755-0241
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
      • Yokohama, Japan, 232-0024
        • Research Site
      • Yokosuka-shi, Japan, 238-8558
        • Research Site
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Research Site
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Arnhem, Netherlands, 6815 AD
        • Research Site
      • Breda, Netherlands, 4818 CK
        • Research Site
      • Groningen, Netherlands, 9713 GZ
        • Research Site
      • Maastricht, Netherlands, 6202 AZ
        • Research Site
      • Rotterdam, Netherlands, 3015 GD
        • Research Site
  • Russia
      • Moscow, Russia, 115478
        • Research Site
      • Moscow, Russia, 105229
        • Research Site
      • Moscow, Russia, 111123
        • Research Site
      • Moscow, Russia, 143423
        • Research Site
      • Moscow, Russia, 125315
        • Research Site
      • Obninsk, Russia, 249036
        • Research Site
      • Omsk, Russia, 644013
        • Research Site
      • Saint Petersburg, Russia, 197758
        • Research Site
      • Saint Petersburg, Russia, 197022
        • Research Site
      • Saint Petersburg, Russia, 194291
        • Research Site
  • South Korea
      • Busan, South Korea, 47392
        • Research Site
      • Changwon-si, South Korea, 51353
        • Research Site
      • Cheongju-si, South Korea, 28644
        • Research Site
      • Daegu, South Korea, 42415
        • Research Site
      • Daegu, South Korea, 42601
        • Research Site
      • Daejeon, South Korea, 35015
        • Research Site
      • Goyang-si, South Korea, 10408
        • Research Site
      • Incheon, South Korea, 21565
        • Research Site
      • Jinju, South Korea, 660-702
        • Research Site
      • Seongnam-si, South Korea, 13620
        • Research Site
      • Seongnam-si, South Korea, 463-712
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
      • Seoul, South Korea, 156-707
        • Research Site
      • Seoul, South Korea, 135-710
        • Research Site
      • Seoul, South Korea, 03181
        • Research Site
      • Seoul, South Korea, 134-791
        • Research Site
      • Suwon, South Korea, 16499
        • Research Site
      • Ulsan, South Korea, 44033
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Alicante, Spain, 03010
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Girona, Spain, 17007
        • Research Site
      • Jaén, Spain, 23007
        • Research Site
      • León, Spain, 24071
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28005
        • Research Site
      • Majadahonda, Spain, 28222
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Seville, Spain, 41009
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • Switzerland
      • Bellinzona, Switzerland, CH-6500
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Research Site
      • Tucson, Arizona, United States, 85715
        • Research Site
      • Yuma, Arizona, United States, 85364
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • La Jolla, California, United States, 92093
        • Research Site
      • Los Angeles, California, United States, 90073
        • Research Site
      • Los Angeles, California, United States, 90024
        • Research Site
      • Redondo Beach, California, United States, 90277
        • Research Site
      • Sacramento, California, United States, 95817
        • Research Site
      • San Luis Obispo, California, United States, 93401
        • Research Site
      • Santa Maria, California, United States, 93454
        • Research Site
      • West Hollywood, California, United States, 90048
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Research Site
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Research Site
    • New York
      • Mineola, New York, United States, 11501
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10021
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Hanoi, Vietnam, 10000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Ho Chi Minh City, Vietnam, 70000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

  • Aged at least 18 years
  • Documented evidence of Stage IV NSCLC
  • No sensitizing EGFR mutation or ALK rearrangement
  • No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  • World Health Organization (WHO) Performance Status of 0 or 1

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
  2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
  3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
  4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care
Standard of Care chemotherapy treatment
Drug: Paclitaxel + Carboplatin
Chemotherapy Agents
Other Names:
  • Platinum based Standard of Care Chemotherapy
Drug: Gemcitabine + Cisplatin
Chemotherapy Agents
Other Names:
  • Platinum based Standard of Care Chemotherapy
Drug: Gemcitabine + Carboplatin
Chemotherapy Agents
Other Names:
  • Platinum based Standard of Care Chemotherapy
Drug: Pemetrexed + Cisplatin
Chemotherapy Agents
Other Names:
  • Platinum based Standard of Care Chemotherapy
Drug: Pemetrexed + Carboplatin
Chemotherapy Agents
Other Names:
  • Platinum based Standard of Care Chemotherapy
Experimental: Monotherapy
PD-L1 monoclonal Antibody monotherapy.
Biological: MEDI4736 (Durvalumab)
Experimental: Combination Therapy
PD-L1+Tremelimumab combination therapy
Biological: MEDI4736 (Durvalumab)+Tremelimumab
Biological: Tremelimumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy
Time Frame: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
Time Frame: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
OS; PD-L1 (TC >=1%) Analysis Set Population
Time Frame: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
OS; FAS Population
Time Frame: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
PFS; PD-L1 (TC >=1%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
PFS; FAS Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
ORR; PD-L1 (TC >=1%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
ORR; FAS Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
DoR; PD-L1 (TC >=1%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
DoR; FAS Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 12 months.
The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 12 months.
The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Percentage of Participants APF12; FAS Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to 12 months.
The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
PFS2; PD-L1 (TC >=1%) Analysis Set Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
PFS2; FAS Population
Time Frame: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months
Time Frame: At baseline then every 4 weeks for the first 8 weeks relative to the date of randomization, then every 8 weeks until second progression/death, whichever comes first. Assessed up to 12 months.
Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items with higher scores representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change is defined as an absolute change in the score from baseline of >=10.
At baseline then every 4 weeks for the first 8 weeks relative to the date of randomization, then every 8 weeks until second progression/death, whichever comes first. Assessed up to 12 months.
Serum Concentrations of Durvalumab
Time Frame: Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.
Blood samples were collected to determine the serum concentration of durvalumab.
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.
Serum Concentrations of Tremelimumab
Time Frame: Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.
Blood samples were collected to determine the serum concentration of tremelimumab.
Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.
Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab
Time Frame: Within 1 hour after end of infusion on infusion day at Week 12.
Blood samples were collected to determine the Cmax_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Within 1 hour after end of infusion on infusion day at Week 12.
Cmax_ss of Tremelimumab
Time Frame: Within 1 hour after end of infusion on infusion day at Week 12.
Blood samples were collected to determine the Cmax_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Within 1 hour after end of infusion on infusion day at Week 12.
Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab
Time Frame: Pre-dose at Week 12.
Blood samples were collected to determine the Ctrough_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Pre-dose at Week 12.
Ctrough_ss of Tremelimumab
Time Frame: Pre-dose at Week 12.
Blood samples were collected to determine the Ctrough_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Pre-dose at Week 12.
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
Time Frame: At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.
Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against durvalumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.
Number of Participants With ADA Response to Tremelimumab
Time Frame: At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.
Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against tremelimumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stuart McIntosh, MD, AstraZeneca, Alderley Park, Cheshire, UK
  • Principal Investigator: Naiyer Rizvi, MD, Columbia University Medical Center, New York, NY, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D419AC00001
  • 2015-001279-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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