A Platform Study in Non-Small Cell Lung Cancer (NSCLC) (ALTAIR)

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.

Study Overview

• Status: Recruiting
• Conditions: Advanced or Metastatic Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Rilvegostomig; Drug: Ramucirumab

Detailed Description

This is a multicentre, open-label study to evaluate the safety and efficacy of various combinations of study interventions in participants with advanced or metastatic NSCLC (mNSCLC).

The study will include a sub-study (sub-study 2) focused on a specific treatment that may include 2 parts -

1. Part A consisting of one of more safety run-in cohorts to evaluate 2 or more dose levels to identify the recommended Phase 2 dose (RP2D) unless RP2D has been established then Part A will not be required; and
2. Part B consisting of one or more expansion cohorts.

The originally planned Sub-study 1 was withdrawn (cancelled) and will not be conducted.

Sub-study 2 will evaluate the safety, tolerability, and anti-tumour activity of rilvegostomig plus standard of care (SoC) platinum-based chemotherapy, with or without ramucirumab.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Not yet recruiting
    • Research Site
  • Hasselt, Belgium, 3500
    • Not yet recruiting
    • Research Site
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Not yet recruiting
    • Research Site
  • Fortaleza, Brazil, 60336-232
    • Not yet recruiting
    • Research Site
  • Natal, Brazil, 59075-740
    • Not yet recruiting
    • Research Site
  • Pelotas, Brazil, 096015-280
    • Not yet recruiting
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Not yet recruiting
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Not yet recruiting
    • Research Site
  • São Paulo, Brazil, 05651-901
    • Not yet recruiting
    • Research Site
• China
  • Chengdu, China, 610041
    • Not yet recruiting
    • Research Site
  • Chongqing, China, 400072
    • Not yet recruiting
    • Research Site
  • Deyang, China, 618000
    • Not yet recruiting
    • Research Site
  • Fuzhou, China, 350014
    • Not yet recruiting
    • Research Site
  • Guangzhou, China, 510405
    • Not yet recruiting
    • Research Site
  • Jinan, China, 250013
    • Not yet recruiting
    • Research Site
  • Shanghai, China, 200433
    • Not yet recruiting
    • Research Site
  • Shanghai, China, 201114
    • Not yet recruiting
    • Research Site
  • Shenyang, China, 110015
    • Not yet recruiting
    • Research Site
  • Shenzhen, China, 518116
    • Not yet recruiting
    • Research Site
  • Wuhan, China, 430022
    • Not yet recruiting
    • Research Site
  • Wuhan, China, 430060
    • Not yet recruiting
    • Research Site
• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Research Site
  • Dijon, France, 21079
    • Not yet recruiting
    • Research Site
  • Limoges, France, 87000
    • Not yet recruiting
    • Research Site
  • Marseille, France, 13015
    • Not yet recruiting
    • Research Site
  • Nantes, France, 44093
    • Not yet recruiting
    • Research Site
  • Nice, France, 06189
    • Not yet recruiting
    • Research Site
  • Paris, France, 75005
    • Not yet recruiting
    • Research Site
• Georgia
  • Batumi, Georgia, 6010
    • Not yet recruiting
    • Research Site
  • Tbilisi, Georgia, 0112
    • Not yet recruiting
    • Research Site
  • Tbilisi, Georgia, 0112
    • Recruiting
    • Research Site
  • Tbilisi, Georgia, 0144
    • Not yet recruiting
    • Research Site
  • Tbilisi, Georgia, 0114
    • Not yet recruiting
    • Research Site
  • Tbilisi, Georgia, 0186
    • Withdrawn
    • Research Site
• Germany
  • München, Germany, 81675
    • Not yet recruiting
    • Research Site
  • Münster, Germany, 48149
    • Withdrawn
    • Research Site
  • Oldenburg, Germany, 26121
    • Withdrawn
    • Research Site
  • Regensburg, Germany, 93053
    • Not yet recruiting
    • Research Site
  • Würzburg, Germany, 97080
    • Not yet recruiting
    • Research Site
• Italy
  • Milan, Italy, 20141
    • Not yet recruiting
    • Research Site
  • Milan, Italy, 20162
    • Not yet recruiting
    • Research Site
  • Orbassano, Italy, 10043
    • Not yet recruiting
    • Research Site
  • Pavia, Italy, 27100
    • Not yet recruiting
    • Research Site
  • Roma, Italy, 00168
    • Not yet recruiting
    • Research Site
• Japan
  • Bunkyō City, Japan, 113-8431
    • Recruiting
    • Research Site
  • Bunkyō City, Japan, 113-8677
    • Recruiting
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Recruiting
    • Research Site
  • Kyoto, Japan, 602-8566
    • Recruiting
    • Research Site
  • Niigata, Japan, 951-8566
    • Recruiting
    • Research Site
  • Shinjuku-ku, Japan, 162-8655
    • Recruiting
    • Research Site
  • Toyoake-shi, Japan, 470-1192
    • Recruiting
    • Research Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • Research Site
  • Kuala Selangor, Malaysia, 62250
    • Recruiting
    • Research Site
  • Kuching, Malaysia, 93586
    • Recruiting
    • Research Site
  • Singapore, Malaysia, 329563
    • Recruiting
    • Research Site
• Moldova
  • Chisinau, Moldova, MD-2025
    • Recruiting
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Not yet recruiting
    • Research Site
  • Groningen, Netherlands, 9713 GZ
    • Not yet recruiting
    • Research Site
  • Leiden, Netherlands, 2333 ZA
    • Not yet recruiting
    • Research Site
• Peru
  • Lima, Peru, 15036
    • Withdrawn
    • Research Site
• Poland
  • Koszalin, Poland, 75-581
    • Not yet recruiting
    • Research Site
  • Lodz, Poland, 93-338
    • Not yet recruiting
    • Research Site
  • Olsztyn, Poland, 10-357
    • Not yet recruiting
    • Research Site
• Serbia
  • Belgrade, Serbia, 11000
    • Withdrawn
    • Research Site
  • Kragujevac, Serbia, 34000
    • Withdrawn
    • Research Site
  • Niš, Serbia, 18000
    • Withdrawn
    • Research Site
• South Korea
  • Seongbuk-Gu, South Korea, 2841
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 05505
    • Recruiting
    • Research Site
  • Seoul, South Korea, 3722
    • Recruiting
    • Research Site
  • Seoul, South Korea, 6351
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Not yet recruiting
    • Research Site
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08908
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Research Site
  • Pamplona, Spain, 31008
    • Not yet recruiting
    • Research Site
  • Pozuelo de Alarcón, Spain, 28223
    • Not yet recruiting
    • Research Site
  • Valencia, Spain, 46010
    • Not yet recruiting
    • Research Site
  • Valencia, Spain, 46009
    • Not yet recruiting
    • Research Site
• Taiwan
  • Taichung, Taiwan, 40201
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 110
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 11696
    • Recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Research Site
  • Chanthaburi, Thailand, 22000
    • Recruiting
    • Research Site
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Research Site
  • Rachathewi, Thailand, 10400
    • Recruiting
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Not yet recruiting
    • Research Site
  • Ankara, Turkey (Türkiye), 6200
    • Not yet recruiting
    • Research Site
  • Fatih, Turkey (Türkiye), 34093
    • Not yet recruiting
    • Research Site
  • Istanbul, Turkey (Türkiye), 34752
    • Withdrawn
    • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Research Site
  • California
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Not yet recruiting
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Research Site
    • Providence, Rhode Island, United States, 02906
      • Withdrawn
      • Research Site
  • Texas
    • Tyler, Texas, United States, 75708
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.
• Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening.
• Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.
• Minimum life expectancy of 12 weeks in the opinion of the investigator.
• Adequate organ and marrow function.
• Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Adequate organ and marrow function.

Inclusion Criteria for Sub Study 2:

• Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 1% (per local report).
• Adequate coagulation and urinalysis.
• Minimum body weight of 30 kg.

Exclusion Criteria:

• Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which targeted therapy is approved in the first line per local standard of care.
• Presence of small cell and neuroendocrine histology components.
• Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease/pneumonitis (of any grade); unstable and/or symptomatic venous thromboembolism, serious chronic gastrointestinal conditions associated with diarrhoea, active non-infectious skin disease or substance abuse.
• Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
• Has an active autoimmune disease that has required systemic treatment in the past 5 years.
• History of clinically significant arrhythmia, cardiomyopathy of any aetiology or symptomatic congestive heart failure.
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention or presence of small cell and neuroendocrine histology components.
• Persistent toxicities (common terminology criteria for adverse events [CTCAE] ≥ Grade 2) caused by previous anti-cancer therapy, excluding alopecia.
• Spinal cord compression or symptomatic brain metastases.
• Treatment with any other anti-cancer agents or immunosuppressive medication.
• Palliative radiotherapy with a limited field of radiation within 2 weeks or with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.

Exclusion Criteria for Sub Study 2:

• Known active hepatitis A.
• Acute hepatitis B infection (anti-hepatitis B core antibody [HBc] immunoglobulin M [IgM] positive) or chronic hepatitis B infection with HBV DNA ≥ 2000 IU/mL.
• Active hepatitis C infection (anti-HCV positive with HCV RNA detectable) or anti- HCV positive with HCV RNA undetectable for less than 12 weeks following treatment for HCV.
• Known human immunodeficiency virus (HIV) infection that is not well controlled.
• Evidence of Grade ≥ 1 central nervous system (CNS) haemorrhage.
• Uncontrolled arterial hypertension ≥ 150 mm Hg (systolic) and/or ≥ 100 mm Hg (diastolic).
• Has radiologically documented evidence of major blood vessel invasion or encasement by cancer, or major airway invasion by cancer or intra-tumour cavitation.
• Has experienced any arterial thrombotic event, a Grade ≥ 3 bleeding event or has gross haemoptysis.
• Has significant bleeding disorders, serious or nonhealing wound, ulcer or clinically relevant congestive heart failure.
• Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
• Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
• Prior systemic therapy received for advanced or mNSCLC.
• Prior exposure to an anti-T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif domains (TIGIT) therapy or immune-oncology agent such as anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.
• Chronic therapy with antiplatelet agents.
• Prior exposure to anti-vascular endothelial growth factor (VEGF) therapy.
• Medical contraindication to protocol-specified platinum doublet regimens or ramucirumab.
• Known allergy or hypersensitivity to rilvegostomig or any of the excipients of rilvegostomig, cisplatin, carboplatin, paclitaxel or nab-paclitaxel or pemetrexed or ramucirumab.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sub study 2 Part A: Safety run-in; Participants with squamous and non-squamous NSCLC will receive combination therapy of rilvegostomig, ramucirumab, and platinum-based chemotherapy to assess the safety and tolerability of this regimen.	Drug: Cisplatin; Cisplatin will be administered as SoC as an IV infusion.; Drug: Carboplatin; Carboplatin will be administered as SoC as an IV infusion.; Drug: Pemetrexed; Pemetrexed will be administered as SoC as an IV infusion.; Drug: Paclitaxel; Paclitaxel will be administered as SoC as an IV infusion.; Drug: Nab-paclitaxel; Nab-paclitaxel will be administered as SoC as an IV infusion.; Drug: Rilvegostomig; Rilvegostomig will be administered as an intravenous (IV) infusion.; Other Names: AZD2936; Drug: Ramucirumab; Ramucirumab will be administered as an IV infusion.
Experimental: Sub study 2 Part B: Dose expansion; Participants will be randomised 1:1 into one of 2 treatment arms (rilvegostomig + chemotherapy + ramucirumab OR rilvegostomig + chemotherapy) in non-squamous histology cohorts and into a single arm (rilvegostomig + chemotherapy+ ramucirumab) in squamous histology cohorts.	Drug: Cisplatin; Cisplatin will be administered as SoC as an IV infusion.; Drug: Carboplatin; Carboplatin will be administered as SoC as an IV infusion.; Drug: Pemetrexed; Pemetrexed will be administered as SoC as an IV infusion.; Drug: Paclitaxel; Paclitaxel will be administered as SoC as an IV infusion.; Drug: Nab-paclitaxel; Nab-paclitaxel will be administered as SoC as an IV infusion.; Drug: Rilvegostomig; Rilvegostomig will be administered as an intravenous (IV) infusion.; Other Names: AZD2936; Drug: Ramucirumab; Ramucirumab will be administered as an IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)	To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.	Approximately 46 months
Part A: Number of partcipants with dose limiting toxicity (DLT)	To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.	Approximately 46 months
Part B: Objective response (OR)	The OR is defined as a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR).	Approximately 46 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Objective response (OR)	The OR is defined as a BOR of confirmed CR or confirmed PR.	Approximately 46 months
Part A and Part B: Duration of response (DOR)	The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).	Approximately 46 months
Part A and Part B: Time to response (TTR)	Time to response is defined as the time from the start of treatment until the date of first documented response.	Approximately 46 months
Part A and Part B: Disease control (DC)	Disease control is defined as if a participant has a best overall response of confirmed CR or confirmed PR or who have stable disease (SD) for at least 7 weeks after start of treatment.	Approximately 46 months
Part A and Part B: Progression free survival (PFS)	Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression.	Approximately 46 months
Part A and Part B: Progression free survival at 6 months (PFS6)	Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression.	From Day 1 pre-dose to 6 months
Part A and Part B: Progression free survival at 12 months (PFS12)	Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression.	From Day 1 pre-dose to 12 months
Part A and Part B: Overall survival (OS)	Overall survival is defined as the time from the start of treatment until death due to any cause regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy.	Approximately 46 months
Part A and Part B: Overall survival at 12 months (OS12)	Overall survival is defined as the time from the start of treatment until death due to any cause regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy.	From Day 1 pre-dose to 12 months
Part A and Part B: Serum concentration	To assess the serum concentration of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Maximum plasma drug concentration (Cmax)	To assess the Cmax of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)	To assess the AUClast of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Area under plasma concentration-time curve from time 0 to infinity (AUC∞)	To assess the AUC∞ of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Time to reach maximum concentration following drug administration (tmax)	To assess the tmax of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Terminal elimination half-life (t1/2λz)	To assess the t1/2λz of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Clearance (CL)	To assess the CL of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Volume of distribution at terminal phase (Vz)	To assess the Vz of the novel anti-cancer agents in combination.	Approximately 46 months
Part A and Part B: Number of participants with anti-drug antibodies (ADAs)	To assess the immunogenicity of the novel anti-cancer agents in combination.	Approximately 46 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): February 23, 2029
• Study Completion (Estimated): February 23, 2029

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Platinum-based chemotherapy; Programmed death-ligand 1 (PD-L1); Checkpoint inhibitor (CPI); T-cell immunoreceptor with lg and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Pemetrexed; Ramucirumab; Carboplatin; Paclitaxel; Cisplatin; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: D702KC00001; 2024-519786-22 (Other Identifier: EU CT 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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No