Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation (PACIFIC-4)

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Durvalumab; Other: Placebo; Drug: (Osimertinib cohort, single-arm, open-label separate cohort)

Detailed Description

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC SBRT.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR-TKI sensitizing mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4-year PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

• Study Type: Interventional
• Enrollment (Actual): 724
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Research Site
• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Charleroi, Belgium, 6000
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Ghent, Belgium, 9000
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Porto Alegre, Brazil, 90110-270
    • Research Site
  • Recife, Brazil, 52010-075
    • Research Site
  • Rio de Janeiro, Brazil, 22271-110
    • Research Site
  • São Paulo, Brazil, 01327-001
    • Research Site
  • Volta Redonda, Brazil, 27258-000
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Research Site
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Research Site
• China
  • Beijing, China, 100142
    • Research Site
  • Beijing, China, 100021
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Chengdu, China, 610042
    • Research Site
  • Fuzhou, China, 350005
    • Research Site
  • Hangzhou, China, 310022
    • Research Site
  • Hangzhou, China, 310002
    • Research Site
  • Hefei, China, 230031
    • Research Site
  • Jinan, China, 250117
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200433
    • Research Site
  • Shanghai, China, 200030
    • Research Site
  • Shanghai, China, 200002
    • Research Site
  • Shenyang, China, 100003
    • Research Site
  • Suzhou, China, 215006
    • Research Site
  • Wenzhou, China, 325000
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430030
    • Research Site
  • Zhengzhou, China, 450008
    • Research Site
• France
  • Bron, France, 69677
    • Research Site
  • Dijon, France, 21079
    • Research Site
  • Lyon, France, 69317
    • Research Site
  • Nantes, France, 44202
    • Research Site
  • Pierre-Bénite, France, 69310
    • Research Site
  • Toulouse, France, 31000
    • Research Site
  • Villejuif, France, 94805
    • Research Site
• Germany
  • Dresden, Germany, 01307
    • Research Site
  • Göttingen, Germany, 37075
    • Research Site
  • Halle, Germany, 06120
    • Research Site
  • Hanover, Germany, 30459
    • Research Site
  • Heidelberg, Germany, 69126
    • Research Site
  • Homburg, Germany, 66424
    • Research Site
  • Regensburg, Germany, 93053
    • Research Site
  • Trier, Germany, 54292
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 11526
    • Research Site
  • Thessaloniki, Greece, 55236
    • Research Site
• Israel
  • Haifa, Israel, 31096
    • Research Site
  • Jerusalem, Israel, 91120
    • Research Site
  • Kfar Saba, Israel, 95847
    • Research Site
  • Petah Tikva, Israel, 49100
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
  • Tel Aviv, Israel, 64239
    • Research Site
• Italy
  • Florence, Italy, 50134
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Milan, Italy, 20132
    • Research Site
  • Orbassano, Italy, 10043
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Roma, Italy, 00128
    • Research Site
  • Rozzano, Italy, 20089
    • Research Site
• Japan
  • Akashi-shi, Japan, 673-8558
    • Research Site
  • Bunkyō City, Japan, 113-8677
    • Research Site
  • Chūōku, Japan, 104-0045
    • Research Site
  • Fukuoka, Japan, 812-8582
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
    • Research Site
  • Hiroshima, Japan, 734-8551
    • Research Site
  • Kobe, Japan, 650-0047
    • Research Site
  • Niigata, Japan, 951-8566
    • Research Site
  • Osaka, Japan, 541-8567
    • Research Site
  • Sakaishi, Japan, 591-8555
    • Research Site
  • Sapporo, Japan, 060-8648
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
  • Toyoake-shi, Japan, 470-1192
    • Research Site
  • Yokohama, Japan, 241-8515
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Research Site
  • Groningen, Netherlands, 9713 GZ
    • Research Site
  • Utrecht, Netherlands, 3584 CX
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • Research Site
  • Elblag, Poland, 02-300
    • Research Site
  • Gdansk, Poland, 80-952
    • Research Site
  • Katowice, Poland, 40-514
    • Research Site
  • Lodz, Poland, 93-513
    • Research Site
  • Warsaw, Poland, 02-781
    • Research Site
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Research Site
• Russia
  • Kazan, Tatarstan, Russia, 420029
    • Research Site
  • Moscow, Russia, 115478
    • Research Site
  • Moscow, Russia, 105229
    • Research Site
  • Moscow, Russia, 119421
    • Research Site
  • Saint Petersburg, Russia, 197758
    • Research Site
  • Ufa, Russia, 450054
    • Research Site
  • Yekaterinburg, Russia, 620905
    • Research Site
• South Korea
  • Cheongju-si, South Korea, 28644
    • Research Site
  • Goyang-si, South Korea, 10408
    • Research Site
  • Gyeonggi-do, South Korea, 13620
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 05505
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
• Spain
  • Badajoz, Spain, 6006
    • Research Site
  • Barcelona, Spain, 08041
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08907
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • San Sebastián, Spain, 20014
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Seville, Spain, 41013
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Research Site
  • Ankara, Turkey (Türkiye), 06010
    • Research Site
  • Istanbul, Turkey (Türkiye), 34214
    • Research Site
  • Izmir, Turkey (Türkiye), 35340
    • Research Site
  • Kocaeli, Turkey (Türkiye), 41400
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Research Site
  • Leeds, United Kingdom, LS9 7TF
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Research Site
• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35401
      • Research Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
    • Phoenix, Arizona, United States, 85004
      • Research Site
    • Tucson, Arizona, United States, 85719
      • Research Site
  • California
    • Duarte, California, United States, 91010
      • Research Site
    • Long Beach, California, United States, 90806
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
  • Delaware
    • Newark, Delaware, United States, 10709
      • Research Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Research Site
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Research Site
    • Jacksonville, Florida, United States, 32256
      • Research Site
    • Miami Beach, Florida, United States, 33140
      • Research Site
    • Orlando, Florida, United States, 32804
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
    • Atlanta, Georgia, United States, 30342
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Research Site
    • Chicago, Illinois, United States, 60637
      • Research Site
    • Chicago, Illinois, United States, 60611
      • Research Site
    • Decatur, Illinois, United States, 62526
      • Research Site
    • Elmhurst, Illinois, United States, 60126
      • Research Site
    • Naperville, Illinois, United States, 60540
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Research Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Research Site
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Research Site
    • Lexington, Kentucky, United States, 40503
      • Research Site
    • Louisville, Kentucky, United States, 40202
      • Research Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Research Site
    • New Orleans, Louisiana, United States, 70121
      • Research Site
  • Maine
    • South Portland, Maine, United States, 04106
      • Research Site
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Research Site
    • Baltimore, Maryland, United States, 21201
      • Research Site
    • Rosedale, Maryland, United States, 21237
      • Research Site
    • Silver Spring, Maryland, United States, 20910
      • Research Site
    • Towson, Maryland, United States, 21204
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Research Site
    • Detroit, Michigan, United States, 48201
      • Research Site
    • Royal Oak, Michigan, United States, 48073
      • Research Site
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Research Site
    • Rochester, Minnesota, United States, 55905
      • Research Site
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89135
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Research Site
    • Paramus, New Jersey, United States, 07652
      • Research Site
  • New York
    • Albany, New York, United States, 12206
      • Research Site
    • East Syracuse, New York, United States, 13057
      • Research Site
    • New Hyde Park, New York, United States, 11042
      • Research Site
    • New York, New York, United States, 10016
      • Research Site
    • Rochester, New York, United States, 14642
      • Research Site
    • Stony Brook, New York, United States, 11794
      • Research Site
    • Syracuse, New York, United States, 13210
      • Research Site
    • The Bronx, New York, United States, 10461
      • Research Site
    • The Bronx, New York, United States, 10467
      • Research Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Research Site
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44304
      • Research Site
    • Cincinnati, Ohio, United States, 45219
      • Research Site
    • Cincinnati, Ohio, United States, 45226
      • Research Site
    • Cleveland, Ohio, United States, 44106
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97213
      • Research Site
    • Portland, Oregon, United States, 97210
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Research Site
    • Watertown, South Dakota, United States, 57201
      • Research Site
  • Texas
    • Austin, Texas, United States, 78745
      • Research Site
    • Dallas, Texas, United States, 75235
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
    • Sherman, Texas, United States, 75090
      • Research Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Research Site
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Research Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • Research Site
    • Seattle, Washington, United States, 98195
      • Research Site
    • Spokane Valley, Washington, United States, 99216
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site

Participation Criteria

Eligibility Criteria

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

Description

Main Cohort Key Inclusion Criteria:

1. Age ≥18 years
2. Planned SoC SBRT as definitive treatment
3. World Health Organization (WHO)/ECOG PS of 0, 1 or 2
4. Life expectancy of at least 12 weeks
5. Body weight >30 kg
6. Submission of tumor tissue sample if available
7. Adequate organ and marrow function required
8. Patients with central or peripheral lesions are eligible
9. Staging studies must be done during screening (PET-CT within 10 weeks)
10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

1. Mixed small cell and non-small cell cancer
2. History of allogeneic organ transplantation
3. History of another primary malignancy with exceptions
4. History of active primary immunodeficiency
5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

1. Age ≥18 years
2. Planned SoC SBRT as definitive treatment
3. WHO/ECOG PS of 0, 1, or 2
4. Patients with central or peripheral lesions are eligible
5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
6. Staging studies must be done during screening (PET-CT within 10 weeks)
7. Submission of tumor tissue sample if available
8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
9. Adequate bone marrow reserve or organ function required
10. Female patients should be using highly effective contraceptive measures
11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

1. Mixed small cell and non-small cell cancer
2. Patients with known or increased risk factor for QTc prolongation

3. Treatment with any of the following:

   • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
   • Prior treatment with neoadjuvant or adjuvant EGFR TKI
   • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

5. Any of the following cardiac criteria

   • Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
   • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
   • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
   • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SoC SBRT + Durvalumab Therapy (Main Cohort); SBRT Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.	Drug: Durvalumab; Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.; Other Names: MEDI4736
Placebo Comparator: SoC SBRT + Placebo Therapy (Main Cohort); SBRT Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.	Other: Placebo; Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
Experimental: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort); SBRT Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT	Drug: (Osimertinib cohort, single-arm, open-label separate cohort); Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC	Main Cohort	from randomization up to 6 years
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria	Osimertinib Cohort	from treatment start up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC	Main Cohort	from randomization up to 6 years
Overall Survival (OS)	Main Cohort	from randomization up to 7 years
Detection of ADA neutralising antibodies titers	Main Cohort	up to 6 months after last dose
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30	Main Cohort	from randomization up to 7 years
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1	Main Cohort	at 24 months following randomization
Time to progression (TTP) assessed by BICR according to RECIST 1.1	Main Cohort	from randomization up to 6 years
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1	Main Cohort	from randomization up to 6 years
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice	Main Cohort	from randomization up to 7 years
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT	Main Cohort	up to 3 months after last dose
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy	Osimertinib Cohort	Up to 35 days after last dose
ECG QT interval	Osimertinib Cohort	Up to 156 weeks of treatment or treatment discontinuation
Concentration of durvalumab in serum such as peak concentration and trough	Main Cohort	12 weeks after last dose
WHO performance status	Osimertinib Cohort	from treatment start up to 5 years
Overall Survival	Osimertinib Cohort	from treatment start up to 5 years
Time To Progression (TTP)	Osimertinib Cohort	from treatment start up to 5 years
Time to CNS progression	Osimertinib Cohort	from treatment start up to 5 years
PFS2	Osimertinib Cohort	from treatment start up to 5 years
Site(s) of disease progression	Osimertinib Cohort	from treatment start up to 5 years
PFS by ICR using RECIST 1.1	Osimertinib Cohort	from treatment start up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Cancer Mortality	Main Cohort	from randomization Up to 5 years
Lung cancer mortality	Osimertinib Cohort	from treatment start up to 5 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Lung Cancer Study Locator details (for US)

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Lung cancer; EGFR; Osimertinib; PD-L1; SBRT; PFS; OS; Durvalumab; MEDI4736; SABR; Early-Stage NSCLC; Double- Blind; Unresected lung cancer; Medically Inoperable; Operable with Patient refusal
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; durvalumab
• Other Study ID Numbers: D9103C00001; 2018-002572-41 (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