A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ARCTIC)

A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)

Study Overview

• Status: Completed
• Conditions: Non - Small Cell Lung Cancer NSCLC
• Intervention / Treatment: Drug: MEDI4736 (durvalumab); Drug: Vinorelbine; Drug: Gemcitabine; Drug: Erlotinib; Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4); Drug: tremelimumab (anti-CTLA4)

Detailed Description

The study has an umbrella design with 2 sub-studies: sub-study A (randomizing patients with PD-L1 positive tumours 1:1 into MEDI4736 (durvalumab) vs. Standard of Care) and sub-study B (randomizing patients with PD-L1 negative tumours 2:3:1:2 into MEDI4736 (durvalumab) vs. MEDI4736 (durvalumab) plus tremelimumab vs. tremelimumab vs. Standard of Care. The two substudies may have different durations of recruitment periods due to differences in patient population (PD-L1 expression). They may not run concurrently with start and completion of recruitment potentially occurring at different time points.

• Study Type: Interventional
• Enrollment (Actual): 597
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Murdoch, Australia, 6150
    • Research Site
  • Port Macquarie, Australia, 2444
    • Research Site
• Belgium
  • Charleroi, Belgium, 6000
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Libramont-Chevigny, Belgium, 6800
    • Research Site
  • Mons, Belgium, 7000
    • Research Site
  • Roeselare, Belgium, 8800
    • Research Site
  • Yvoir, Belgium, 5530
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Research Site
  • Sofia, Bulgaria, 1407
    • Research Site
  • Sofia, Bulgaria, 1330
    • Research Site
  • Varna, Bulgaria, 9010
    • Research Site
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Research Site
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Research Site
• Chile
  • Santiago, Chile, 7500000
    • Research Site
  • Santiago, Chile, 8420383
    • Research Site
  • Temuco, Chile, 4810469
    • Research Site
• Czechia
  • Nova Ves pod Plesi, Czechia, 262 04
    • Research Site
  • Praha 2, Czechia, 128 08
    • Research Site
  • Praha 5, Czechia, 150 06
    • Research Site
• France
  • Avignon Cedex 9, France, 84918
    • Research Site
  • Bayonne, France, 64100
    • Research Site
  • Brest Cedex, France, 29609
    • Research Site
  • Creteil, France, 94010
    • Research Site
  • Le Mans, France, 72000
    • Research Site
  • Marseille Cedex 20, France, 13915
    • Research Site
  • Montpellier Cedex, France, 34295
    • Research Site
  • Nice, France, 06100
    • Research Site
  • Pau Cedex, France, 64046
    • Research Site
  • Saint Herblain, France, 44805
    • Research Site
  • Toulon, France, 83100
    • Research Site
  • Villejuif, France, 94800
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Research Site
  • Berlin, Germany, 12351
    • Research Site
  • Berlin, Germany, 10967
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Gauting, Germany, 82131
    • Research Site
  • Halle, Germany, 06120
    • Research Site
  • Hamburg, Germany, 22081
    • Research Site
  • Hannover, Germany, 30625
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  • Homburg, Germany, 66421
    • Research Site
  • Köln, Germany, 51109
    • Research Site
  • Löwenstein, Germany, 74245
    • Research Site
  • Regensburg, Germany, 93053
    • Research Site
  • Trier, Germany, 54290
    • Research Site
  • Ulm, Germany, 89081
    • Research Site
  • Villingen-Schwenningen, Germany, 78052
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Thessaloniki, Greece, 57010
    • Research Site
  • Thessaloniki, Greece, 54645
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
• Hungary
  • Miskolc, Hungary, 3529
    • Research Site
  • Törökbálint, Hungary, 2045
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
  • Zalaegerszeg, Hungary, 8000
    • Research Site
• Israel
  • Tel Hashomer, Israel, 52621
    • Research Site
• Italy
  • Aviano, Italy, 33081
    • Research Site
  • Candiolo, Italy, 10060
    • Research Site
  • Catania, Italy, 95123
    • Research Site
  • Cremona, Italy, 26100
    • Research Site
  • Genova, Italy, 16100
    • Research Site
  • Lucca, Italy, 55100
    • Research Site
  • Milano, Italy, 20141
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Milano, Italy, 20133
    • Research Site
  • Monza, Italy, 20900
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Orbassano, Italy, 10043
    • Research Site
  • Parma, Italy, 43100
    • Research Site
  • Pisa, Italy, 56124
    • Research Site
  • Rimini, Italy, 47900
    • Research Site
  • Terni, Italy, 05100
    • Research Site
• Japan
  • Fukuoka-shi, Japan, 812-8582
    • Research Site
  • Habikino-shi, Japan, 583-8588
    • Research Site
  • Hidaka-shi, Japan, 350-1298
    • Research Site
  • Hirakata-shi, Japan, 573-1191
    • Research Site
  • Hirosaki-shi, Japan, 036-8545
    • Research Site
  • Hiroshima-shi, Japan, 730-8518
    • Research Site
  • Kanazawa, Japan, 920-8641
    • Research Site
  • Kobe-shi, Japan, 650-0047
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Matsuyama-shi, Japan, 791-0280
    • Research Site
  • Nagoya-shi, Japan, 464-8681
    • Research Site
  • Nagoya-shi, Japan, 466-8560
    • Research Site
  • Nagoya-shi, Japan, 460-0001
    • Research Site
  • Natori-shi, Japan, 981-1293
    • Research Site
  • Okayama-shi, Japan, 700-8558
    • Research Site
  • Osaka-shi, Japan, 541-8567
    • Research Site
  • Osakasayama, Japan, 589-8511
    • Research Site
  • Sakai-shi, Japan, 591-8555
    • Research Site
  • Sapporo-shi, Japan, 003-0804
    • Research Site
  • Sapporo-shi, Japan, 060-8648
    • Research Site
  • Sendai-shi, Japan, 980-0873
    • Research Site
  • Shinjuku-ku, Japan, 162-8655
    • Research Site
  • Shinjuku-ku, Japan, 160-0023
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
  • Takatsuki-shi, Japan, 569-8686
    • Research Site
  • Wakayama-shi, Japan, 641-8510
    • Research Site
  • Yokohama-shi, Japan, 236-0024
    • Research Site
  • Yokohama-shi, Japan, 221-0855
    • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Research Site
  • Cheongju-si, Korea, Republic of, 28644
    • Research Site
  • Incheon, Korea, Republic of, 405-760
    • Research Site
  • Jeonnam, Korea, Republic of, 58128
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Research Site
  • Seoul, Korea, Republic of, 02841
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Research Site
• Poland
  • Lublin, Poland, 20-362
    • Research Site
  • Poznań, Poland, 60-569
    • Research Site
  • Warszawa, Poland, 02-781
    • Research Site
• Romania
  • Alba Iulia, Romania, 510077
    • Research Site
  • Baia Mare, Romania, 430031
    • Research Site
  • Cluj Napoca, Romania, 400349
    • Research Site
  • Cluj-Napoca, Romania, 400132
    • Research Site
  • Onesti, Romania, 601048
    • Research Site
  • Oradea, Romania, 410469
    • Research Site
  • Timisoara, Romania, 300210
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Research Site
  • Omsk, Russian Federation, 644013
    • Research Site
  • Saint Petersburg, Russian Federation, 197758
    • Research Site
  • St. Petersburg, Russian Federation, 197022
    • Research Site
  • St. Petersburg, Russian Federation, 197758
    • Research Site
  • St. Petersburg, Russian Federation, 197002
    • Research Site
• Serbia
  • Belgrad, Serbia, 11000
    • Research Site
  • Belgrade, Serbia, 11000
    • Research Site
  • Gornji Matejevac, Serbia, 18204
    • Research Site
  • Kragujevac, Serbia, 34000
    • Research Site
  • Sremska Kamenica, Serbia, 21204
    • Research Site
• Singapore
  • Singapore, Singapore, 169610
    • Research Site
  • Singapore, Singapore, 308433
    • Research Site
  • Singapore, Singapore, 119074
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • Alicante, Spain, 03010
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Girona, Spain, 17007
    • Research Site
  • Jaén, Spain, 23007
    • Research Site
  • Lleida, Spain, 25198
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 08035
    • Research Site
  • Madrid, Spain, 28050
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Madrid, Spain, 28033
    • Research Site
  • Madrid, Spain, 28005
    • Research Site
  • San Sebastian, Spain, 20014
    • Research Site
  • Sevilla, Spain, 41013
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Valencia, Spain, 46014
    • Research Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 235
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taipei, Taiwan, 112
    • Research Site
  • Taipei, Taiwan, 116
    • Research Site
  • Taipei City, Taiwan, 110
    • Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • Research Site
  • Muang, Thailand, 50200
    • Research Site
  • Phitsanulok, Thailand, 65000
    • Research Site
  • Songkla, Thailand, 90110
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Research Site
  • London, United Kingdom, W1G 6AD
    • Research Site
  • Southampton, United Kingdom, SO16 6YD
    • Research Site
  • Stevenage, United Kingdom, SG1 4AB
    • Research Site
  • Truro, United Kingdom, TR1 3LJ
    • Research Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • Research Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
  • California
    • Anaheim, California, United States, 92801
      • Research Site
    • Duarte, California, United States, 91010
      • Research Site
    • La Jolla, California, United States, 92093
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Research Site
    • Orlando, Florida, United States, 32804
      • Research Site
    • Port Saint Lucie, Florida, United States, 34952
      • Research Site
    • Saint Petersburg, Florida, United States, 33705
      • Research Site
  • Georgia
    • Athens, Georgia, United States, 30607
      • Research Site
    • Atlanta, Georgia, United States, 30322
      • Research Site
    • Lawrenceville, Georgia, United States, 30046
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Research Site
  • Iowa
    • Waterloo, Iowa, United States, 50701
      • Research Site
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Research Site
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Research Site
  • Michigan
    • Battle Creek, Michigan, United States, 49017
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63156
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Research Site
  • New York
    • Bronx, New York, United States, 10461-2375
      • Research Site
    • Mineola, New York, United States, 11501
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • New York, New York, United States, 10011
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Pinehurst, North Carolina, United States, 28374
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Research Site
    • West Chester, Ohio, United States, 45069
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Research Site
    • Germantown, Tennessee, United States, 38138
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Research Site
  • Washington
    • Spokane, Washington, United States, 99208
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged at least 18 years
• Documented evidence of NSCLC (Stage IIIB/ IV disease)
• Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
• World Health Organization (WHO) Performance Status of 0 or 1
• Estimated life expectancy more than 12 weeks

Exclusion Criteria:

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
• Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
• Active or prior documented autoimmune disease within the past 2 years
• Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
• Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
• Known EGFR TK activating mutations or ALK rearrangements
• Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
• Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEDI4736 (durvalumab) monotherapy in Sub-study A; MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.	Drug: MEDI4736 (durvalumab); MEDI4736 (durvalumab) treatment by intravenous infusion
Active Comparator: Standard of Care in Sub-study A; Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.	Drug: Vinorelbine; Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.; Drug: Gemcitabine; Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.; Drug: Erlotinib; Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
Experimental: MEDI4736 (durvalumab) + tremelimumab in Sub-study B; MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.	Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4); MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
Active Comparator: Standard of Care in Sub-study B; Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.	Drug: Vinorelbine; Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.; Drug: Gemcitabine; Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.; Drug: Erlotinib; Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
Experimental: MEDI4736 (durvalumab) monotherapy in Sub-study B; MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.	Drug: MEDI4736 (durvalumab); MEDI4736 (durvalumab) treatment by intravenous infusion
Experimental: tremelimumab in Sub-study B; tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.	Drug: tremelimumab (anti-CTLA4); tremelimumab (anti-CTLA4) treatment by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	The OS was defined as the time from the date of randomization until death due to any cause.	From randomization (Day 1) until death due to any cause, approximately 36 months
Progression-Free Survival (PFS)	The PFS 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 withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion	Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS, Contribution of the Components Analysis of Sub-study B	The OS was defined as the time from the date of randomization until death due to any cause.	From randomization (Day 1) until death due to any cause, approximately 36 months
Percentage of Participants Alive at 12 Months (OS12)	The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months.	From randomization (Day 1) up to 12 months
PFS, Contribution of the Components Analysis of Sub-study B	The PFS 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 withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion	Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
Objective Response Rate (ORR)	The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions 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 target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1.	Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
Duration of Response (DoR)	The DoR 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. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion	Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
Percentage of Participants Alive and Progression Free at 6 Months (APF6)	The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion	Tumour scans performed at baseline then every ~8 weeks up to 6 months
Percentage of Participants Alive and Progression Free at 12 Months (APF12)	The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion	Tumour scans performed at baseline then every ~8 weeks up to 12 months.
Time From Randomisation to Second Progression (PFS2) of Sub-study B	The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only.	Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Paul Stockman, MBChB, PhD, AstraZeneca

Publications and helpful links

General Publications

• Martin ML, Correll J, Walding A, Ryden A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2022 Jan;31(1):135-146. doi: 10.1007/s11136-021-02882-6. Epub 2021 May 31.
• Planchard D, Reinmuth N, Orlov S, Fischer JR, Sugawara S, Mandziuk S, Marquez-Medina D, Novello S, Takeda Y, Soo R, Park K, McCleod M, Geater SL, Powell M, May R, Scheuring U, Stockman P, Kowalski D. ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer. Ann Oncol. 2020 May;31(5):609-618. doi: 10.1016/j.annonc.2020.02.006. Epub 2020 Feb 20.

Helpful Links

• AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com Phone number: 1-877-400-465
• Redacted SAP
• Redacted CSP
• CSR Synopsis redacted

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2015
• Primary Completion (Actual): February 9, 2018
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimated): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Erlotinib Hydrochloride; Durvalumab; Tremelimumab; Antibodies, Monoclonal; Vinorelbine; Gemcitabine
• Other Study ID Numbers: D4191C00004; 2014-000338-46 (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