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

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: Active, not recruiting
• Conditions: Metastatic Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Volrustomig

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: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

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
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  • Quebec
    • Lévis, Quebec, Canada, G6V 3Z1
      • Research Site
    • 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
    • Research Site
  • Chengdu, China, 610000
    • Research Site
  • Chengdu, China, 611135
    • Research Site
  • 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
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  • Lanzhou, China, 730000
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  • Linhai, China, 317000
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  • Linyi, China, 276001
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  • Nanchang, China, 330006
    • Research Site
  • Nanchang, China, 330008
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  • Nanjing, China, 210009
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  • Nanning, China, 530021
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  • Shanghai, China, 200032
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  • Shanghai, China, 200433
    • Research Site
  • Shanghai, China, 200030
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  • Shenzhen, China, 518116
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  • Taiyuan, China, 030000
    • Research Site
  • Tianjin, China, 300060
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  • Wuhan, China, 430079
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  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430030
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  • Xi'an, China, 710000
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  • Yangzhou, China, 225001
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  • Zhengzhou, China, 450008
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• 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, 700016
    • Research Site
  • Mysuru, India, 570017
    • Research Site
  • Nagpur, India, 440001
    • Research Site
  • Nashik, India, 422011
    • Research Site
  • Varanasi, India, 221005
    • Research Site
• Italy
  • Bari, Italy, 70124
    • Research Site
  • Bergamo, Italy, 24125
    • Research Site
  • Milan, Italy, 20162
    • Research Site
  • Padua, 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
  • Daegu, South Korea, 42601
    • 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
  • Kaohsiung City, Taiwan, 833
    • 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 District, Taiwan, 33305
    • Research Site
  • Yunlin, Taiwan, 640
    • Research Site
• Thailand
  • Bangkok, Thailand, 10700
    • Research Site
  • Dusit, Thailand, 10300
    • Research Site
  • 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
  • Arizona
    • Prescott, Arizona, United States, 86301
      • Research Site
  • 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
    • Gainesville, Florida, United States, 32610
      • 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
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • 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 Mexico
    • Albuquerque, New Mexico, United States, 87102
      • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)	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.	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

Outcome Measure	Measure Description	Time Frame
PFS (using BICR assessments according to RECIST 1.1)	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	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)	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)	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)	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	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	To assess the PK of volrustomig	Up to approximately 6 years
Presence of ADAs against volrustomig in serum	To investigate the immunogenicity of volrustomig.	Up to approximately 6 years
Time-To-Deterioration (TTD) in physical functioning	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	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

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CTIS structured data update

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): April 24, 2028
• Study Completion (Estimated): March 23, 2029

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PD-L1; metastatic non-small cell lung cancer; non-squamous tumors; squamous tumors
• 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; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Pemetrexed; Carboplatin; Paclitaxel; pembrolizumab
• Other Study ID 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