A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. (eVOLVE-Lung02)

July 27, 2026 updated by: AstraZeneca

A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

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

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig + chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

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.
895

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • CABA, Argentina, 1425
        • Research Site
      • CABA, Argentina, C1061
        • Research Site
      • CABA, Argentina, C1425
        • Research Site
      • Córdoba, Argentina, 5000
        • Research Site
      • Córdoba, Argentina, X5800HHW
        • Research Site
      • La Plata, Argentina, 1900
        • Research Site
      • La Plata, Argentina, B1900AVG
        • Research Site
      • Rosario, Argentina, 2000
        • Research Site
  • Australia
      • Clayton, Australia, 3168
        • Research Site
      • Fitzroy, Australia, 3065
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • South Brisbane, Australia, 4101
        • Research Site
      • Sydney, Australia, NSW 2145
        • Research Site
  • Austria
      • Linz, Austria, 4021
        • Research Site
      • Wels, Austria, 4600
        • Research Site
  • Belgium
      • Aalst, Belgium, 9300
        • Research Site
      • Antwerp, Belgium, 2020
        • Research Site
      • Ghent, Belgium, 9000
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Curitiba, Brazil, 80730-150
        • Research Site
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Fortaleza, Brazil, 60336-045
        • Research Site
      • Natal, Brazil, 59075-740
        • Research Site
      • Porto Alegre, Brazil, 90619-900
        • Research Site
      • Porto Alegre, Brazil, 91350200
        • Research Site
      • Rio de Janeiro, Brazil, 22281-100
        • Research Site
      • Santa Cruz do Sul, Brazil, 96810-110
        • Research Site
      • São Paulo, Brazil, 01221-020
        • Research Site
  • Canada
      • Chicoutimi, Canada, G7H 5H6
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Research Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Research Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
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      • Trois-Rivières, Quebec, Canada, G8Z 3R0
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  • China
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100021
        • Research Site
      • Beijing, China, 101149
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Changsha, China, 410013
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      • Chengdu, China, 610000
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      • Chengdu, China, 611135
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      • Chongqing, China, 400030
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      • Fuzhou, China, 350011
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      • Guangzhou, China, 510080
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      • Hangzhou, China, 310022
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      • Hangzhou, China, 310020
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      • Hefei, China, 230601
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Linhai, China, 317000
        • Research Site
      • Linyi, China, 276001
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanchang, China, 330008
        • Research Site
      • Nanjing, China, 210009
        • Research Site
      • Nanning, China, 530021
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200433
        • Research Site
      • Shanghai, China, 200030
        • Research Site
      • Shenzhen, China, 518116
        • Research Site
      • Taiyuan, China, 030000
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Wuhan, China, 430079
        • Research Site
      • Wuhan, China, 430022
        • Research Site
      • Wuhan, China, 430030
        • Research Site
      • Xi'an, China, 710000
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
  • Czechia
      • Olomouc, Czechia, 77900
        • Research Site
      • Ostrava - Vitkovice, Czechia, 703 84
        • Research Site
      • Prague, Czechia, 128 08
        • Research Site
  • France
      • Angers, France, 49055
        • Research Site
      • Avignon, France, 84902
        • Research Site
      • Bayonne, France, 64100
        • Research Site
      • Bordeaux, France, 33076
        • Research Site
      • Caen, France, 14033
        • Research Site
      • Lille, France, 59037
        • Research Site
      • Limoges, France, 87042
        • Research Site
      • Marseille, France, 13273
        • Research Site
      • Paris, France, 75248
        • Research Site
      • Quimper, France, 29000
        • Research Site
      • Reims, France, 51092
        • Research Site
      • St-Malo, France, 35403
        • Research Site
      • Strasbourg, France, 67098
        • Research Site
      • Suresnes, France, 92150
        • Research Site
      • Toulon Naval, France, 83800
        • Research Site
  • Germany
      • Berlin-Zehlendorf, Germany, 14165
        • Research Site
      • Bonn, Germany, 53113
        • Research Site
      • Braunschweig, Germany, 38114
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Research Site
      • Gauting, Germany, 82131
        • Research Site
      • Georgsmarienhütte, Germany, 49124
        • Research Site
      • Gütersloh, Germany, 33332
        • Research Site
      • Halle, Germany, 06120
        • Research Site
      • Hamburg, Germany, 22087
        • Research Site
      • Heidelberg, Germany, 69126
        • Research Site
      • Immenhausen, Germany, 34376
        • Research Site
      • Koblenz, Germany, 56068
        • Research Site
      • Ludwigsburg, Germany, 71640
        • Research Site
      • Nuremberg, Germany, 90419
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
      • Velbert, Germany, 42551
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1121
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Gyöngyös, Hungary, 3200
        • Research Site
      • Gyöngyös - Mátraháza, Hungary, 3200
        • Research Site
      • Győr, Hungary, 9024
        • Research Site
      • Pécs, Hungary, 7624
        • Research Site
      • Szekszárd, Hungary, 7100
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • India
      • Bengaluru, India, 560085
        • Research Site
      • Hyderabad, India, 500032
        • Research Site
      • Kolkata, India, 700094
        • Research Site
      • Mysuru, India, 570017
        • Research Site
      • Nagpur, India, 440001
        • Research Site
      • Varanasi, India, 221005
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Bergamo, Italy, 24125
        • Research Site
      • Milan, Italy, 20162
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Parma, Italy, 43126
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Ravenna, Italy, 48100
        • Research Site
      • Roma, Italy, 00128
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8677
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
      • Kawasaki-shi, Japan, 216-8511
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Sagamihara-shi, Japan, 252-0375
        • Research Site
      • Sakai, Japan, 590-0197
        • Research Site
      • Sapporo, Japan, 001-0013
        • Research Site
      • Sendai, Japan, 980-0873
        • Research Site
      • Ube-shi, Japan, 755-0241
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Groningen, Netherlands, 9728 NT
        • Research Site
      • Nieuwegein, Netherlands, 3435 CM
        • Research Site
      • Tilburg, Netherlands, 5042AD
        • Research Site
  • Poland
      • Lublin, Poland, 20-090
        • Research Site
      • Poznan, Poland, 60-569
        • Research Site
      • Przemyśl, Poland, 37-700
        • Research Site
      • Radom, Poland, 26-600
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
      • Warsaw, Poland, 01-138
        • Research Site
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Research Site
      • Bratislava, Slovakia, 82606
        • Research Site
      • Bratislava, Slovakia, 833 01
        • Research Site
      • Košice, Slovakia, 041 91
        • Research Site
      • Trnava, Slovakia, 917 75
        • Research Site
  • South Africa
      • George, South Africa, 6529
        • Research Site
      • Johannesburg, South Africa, 2193
        • Research Site
      • Johannesburg, South Africa, 2196
        • Research Site
      • Pietermaritzburg, South Africa, 3245
        • Research Site
      • Pretoria, South Africa, 0002
        • Research Site
      • Rondebosch, South Africa, 7700
        • Research Site
      • Soweto, South Africa, 2013
        • Research Site
      • eManzimtoti, South Africa, 4126
        • Research Site
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Research Site
      • Incheon, South Korea, 21565
        • Research Site
      • Jinju, South Korea, 52727
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 07061
        • Research Site
      • Suwon, South Korea, 16499
        • Research Site
      • Suwon, South Korea, 16247
        • Research Site
  • Spain
      • Alicante, Spain, 03010
        • Research Site
      • Barcelona, Spain, 08003
        • Research Site
      • Barcelona, Spain, 08025
        • Research Site
      • Bilbao (Vizcaya), Spain, 48013
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Málaga, Spain, 29011
        • Research Site
      • Palma, Spain, 07198
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • New Taipei City, Taiwan, 220
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Tainan, Taiwan, 73657
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taipei, Taiwan, 11490
        • Research Site
      • Taoyuan, Taiwan, 33305
        • Research Site
      • Yunlin, Taiwan, 640
        • Research Site
  • Thailand
      • Lampang, Thailand, 52000
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Songkhla, Thailand, 90110
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6500
        • Research Site
      • Antalya, Turkey (Türkiye), 07059
        • Research Site
      • Diyarbakır, Turkey (Türkiye), 21280
        • Research Site
      • Fatih-Istanbul, Turkey (Türkiye), 34098
        • Research Site
      • Istanbul, Turkey (Türkiye), 34722
        • Research Site
      • Izmir, Turkey (Türkiye), 35100
        • Research Site
      • Pamukkale, Turkey (Türkiye), 20070
        • Research Site
      • Çankaya, Turkey (Türkiye), 06680
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Research Site
      • Blackpool, United Kingdom, FY3 8NR
        • Research Site
      • Bury St Edmunds, United Kingdom, IP332QZ
        • Research Site
      • Colchester, United Kingdom, CO4 5JL
        • Research Site
      • London, United Kingdom, EC1A 7BE
        • Research Site
      • London, United Kingdom, SW10 9NH
        • Research Site
      • London, United Kingdom, SW170QT
        • Research Site
      • Truro, United Kingdom, TR1 3LJ
        • Research Site
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Research Site
      • Springdale, Arkansas, United States, 72762
        • Research Site
    • California
      • Long Beach, California, United States, 90806
        • Research Site
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Research Site
      • Orlando, Florida, United States, 32827
        • Research Site
      • St. Petersburg, Florida, United States, 33705
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Research Site
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Louisville, Kentucky, United States, 40206
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
      • Baltimore, Maryland, United States, 21201
        • Research Site
      • Silver Spring, Maryland, United States, 20904
        • Research Site
      • Towson, Maryland, United States, 21204
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Research Site
      • Lincoln, Nebraska, United States, 68506
        • Research Site
      • Omaha, Nebraska, United States, 68130
        • Research Site
    • New York
      • East Syracuse, New York, United States, 13057
        • Research Site
      • Fresh Meadows, New York, United States, 11366
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Research Site
      • Columbus, Ohio, United States, 43219
        • Research Site
      • Dayton, Ohio, United States, 45428
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
      • Nashville, Tennessee, United States, 37212
        • Research Site
    • Texas
      • Houston, Texas, United States, 77090
        • Research Site
      • Irving, Texas, United States, 75063
        • Research Site
      • Lancaster, Texas, United States, 75216
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Histologically or cytologically documented squamous or non-squamous NSCLC.
  • Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
  • Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
  • Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.

Key Exclusion Criteria:

  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
  • Spinal cord compression.
  • Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment.

  • History of another primary malignancy except for:

    1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    3. Adequately treated carcinoma in situ without evidence of disease.
  • As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.

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.
Experimental: Arm 1
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Drug: Carboplatin
Carboplatin
Drug: Paclitaxel
Paclitaxel
Drug: Pemetrexed
Pemetrexed
Drug: Volrustomig
Volrustomig
Active Comparator: Arm 2
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Drug: Pembrolizumab
Pembrolizumab
Drug: Carboplatin
Carboplatin
Drug: Paclitaxel
Paclitaxel
Drug: Pemetrexed
Pemetrexed

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
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
Time Frame: Up to approximately 6 years
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.
Up to approximately 6 years
Overall Survival (OS), in PD-L1-negative participants.
Time Frame: Up to approximately 6 years
OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
Up to approximately 6 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
PFS (using BICR assessments according to RECIST 1.1)
Time Frame: Up to approximately 6 years
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.
Up to approximately 6 years
OS
Time Frame: Up to approximately 6 years
OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.
Up to approximately 6 years
PFS (using Investigator assessments according to RECIST 1.1)
Time Frame: Up to approximately 6 years
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).
Up to approximately 6 years
Overall Response Rate (ORR)
Time Frame: Up to approximately 6 years
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.
Up to approximately 6 years
Duration of Response (DoR)
Time Frame: Up to approximately 6 years
DoR is defined as the time from the date of first documented response until the date of documented progression per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.
Up to approximately 6 years
PFS2
Time Frame: Up to approximately 6 years
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.
Up to approximately 6 years
Concentration of volrustomig in serum and PK parameters
Time Frame: Up to approximately 6 years
To assess the PK of volrustomig
Up to approximately 6 years
Presence of ADAs against volrustomig in serum
Time Frame: Up to approximately 6 years
To investigate the immunogenicity of volrustomig.
Up to approximately 6 years
Time-To-Deterioration (TTD) in physical functioning
Time Frame: Up to approximately 6 years
To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
Up to approximately 6 years
TTD of lung cancer symptoms
Time Frame: Up to approximately 6 years
To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
Up to approximately 6 years

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

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.

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.
October 24, 2023

Primary Completion (Estimated)

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.
February 28, 2029

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.
February 28, 2029

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).
August 2, 2023

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.
August 2, 2023

First Posted (Actual)

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.
August 9, 2023

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.
July 28, 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.
July 27, 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.
July 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.
  • D798AC00001
  • 2023-000056-38 (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. SignedData Sharing Agreement (non-negotiable contract for data accessors) must be inplace before accessing requested information. Additionally, all users will need toaccept the terms and conditions of the SAS MSE to gain access. For additionaldetails, please review the Disclosure Statements athttps://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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