A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)

June 10, 2025 updated by: AstraZeneca

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Research Site
      • Caba, Argentina, C1012AAR
        • Research Site
      • Caba, Argentina, C1280AEB
        • Research Site
      • La Plata, Argentina, 1900
        • Research Site
      • Pergamino, Argentina, B2700CPM
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Research Site
      • San Salvador de Jujuy, Argentina, 4600
        • Research Site
      • Viedma, Argentina, R8500ACE
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Rankweil, Austria, 6830
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Wien, Austria, 1210
        • Research Site
  • Belgium
      • Gent, Belgium, 9000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Mons, Belgium, 7000
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Belo Horizonte, Brazil, 30380-090
        • Research Site
      • Campinas, Brazil, 13060-904
        • Research Site
      • Curitiba, Brazil, 81520-060
        • Research Site
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Natal, Brazil, 59075-740
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Santa Maria, Brazil, 97015-450
        • Research Site
      • Sao Paulo, Brazil, 01323-903
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
      • Teresina, Brazil, 64049-200
        • Research Site
      • Vitoria, Brazil, 29043-260
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1797
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Research Site
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • Research Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Research Site
  • Chile
      • Santiago, Chile, 7500713
        • Research Site
      • Santiago, Chile, 7500921
        • Research Site
      • Temuco, Chile, 4810469
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Research Site
  • China
      • Beijing, China, 100021
        • Research Site
      • Beijing, China, 101149
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Beijing, China, 100191
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Changsha, China, 410008
        • Research Site
      • Changzhou, China, 213000
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Guangzhou, China, 510515
        • Research Site
      • Guangzhou, China, 510095
        • Research Site
      • Guiyang, China, 550002
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Hangzhou, China, 310003
        • Research Site
      • Hangzhou, China, 310052
        • Research Site
      • Hangzhou, China, 310030
        • Research Site
      • Hefei, China, 230001
        • Research Site
      • Kunming, China, 650118
        • Research Site
      • Linhai, China, 317000
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Ningbo, China, 315000
        • Research Site
      • Shanghai, China, 200433
        • Research Site
      • Shanghai, China, 200052
        • Research Site
      • Shenyang, China, 110042
        • Research Site
      • Shenyang, China, 110044
        • Research Site
      • Shenzhen, China, 518035
        • Research Site
      • Shenzhen, China, 518036
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Urumqi, China, 830000
        • Research Site
      • Wuhan, China, 430079
        • Research Site
      • Wuhan, China, 430060
        • Research Site
      • Xiamen, China, 361004
        • Research Site
      • Xintai, China, 54031
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
  • Costa Rica
      • San José, Costa Rica, 1000
        • Research Site
      • San José, Costa Rica, 10108
        • Research Site
  • France
      • Avignon Cedex, France, 84902
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
      • Nice, France, 06100
        • Research Site
      • Toulon Cedex 9, France, 83800
        • Research Site
      • Vantoux, France, 57070
        • Research Site
  • Germany
      • Bielefeld, Germany, 33611
        • Research Site
      • Frankfurt am Main, Germany, 60431
        • Research Site
      • Immenstadt, Germany, 87509
        • Research Site
      • Köln, Germany, 51109
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Gyöngyös - Mátraháza, Hungary, 3200
        • Research Site
      • Győr, Hungary, 9024
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • India
      • Ahmedabad, India, 380060
        • Research Site
      • Gurgaon, India, 122001
        • Research Site
      • Gurgaon, India, 122002
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Manipal, India, 576104
        • Research Site
      • Mumbai, India, 400053
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • Mysuru, India, 570017
        • Research Site
      • Namakkal, India, 637001
        • Research Site
      • Nashik, India, 422002
        • Research Site
      • New Delhi, India, 110085
        • Research Site
      • New Delhi, India, 110076
        • Research Site
      • Thane, India, 401107
        • Research Site
      • Vishakhapatnam, India, 530017
        • Research Site
  • Italy
      • Ancona, Italy, 60126
        • Research Site
      • Bari, Italy, 70124
        • Research Site
      • Bergamo, Italy, 24127
        • Research Site
      • Firenze, Italy, 50134
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Monza, Italy, 20900
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Roma, Italy, 00100
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • Japan
      • Habikino-shi, Japan, 583-8588
        • Research Site
      • Himeji-shi, Japan, 670-8520
        • Research Site
      • Hiroshima-shi, Japan, 730-8518
        • Research Site
      • Hiroshima-shi, Japan, 734-8551
        • Research Site
      • Iwakuni-shi, Japan, 740-8510
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Research Site
      • Kitakyushu-shi, Japan, 807-8555
        • Research Site
      • Kurashiki shi, Japan, 701 0192
        • Research Site
      • Nagoya-shi, Japan, 464-8681
        • Research Site
      • Niigata-shi, Japan, 951-8566
        • Research Site
      • Okayama-shi, Japan, 700-8558
        • Research Site
      • Osakasayama-shi, Japan, 589-8511
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
      • Wakayama-shi, Japan, 641-8510
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Research Site
      • Cheongju-si, Korea, Republic of, 28644
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
      • Suwon, Korea, Republic of, 442-723
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Research Site
      • Chihuahua, Mexico, 31000
        • Research Site
      • Guadalajara, Mexico, 44680
        • Research Site
      • Monterrey, Mexico, 64710
        • Research Site
      • Monterrey, Mexico, 64000
        • Research Site
      • México, Mexico, 1400
        • Research Site
      • México, Mexico, 14050
        • Research Site
      • Pachuca de Soto, Mexico, 42090
        • Research Site
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Research Site
      • Nijmegen, Netherlands, 6525 GA
        • Research Site
  • Peru
      • Bellavista, Peru, CALLAO 2
        • Research Site
      • Lima, Peru, LIMA 34
        • Research Site
      • Lima, Peru, LIMA 31
        • Research Site
      • Lima, Peru, Lima 32
        • Research Site
      • Lima, Peru, LIMA 11
        • Research Site
  • Philippines
      • Davao City, Philippines, 8000
        • Research Site
      • Iloilo City, Philippines, 5000
        • Research Site
      • Makati, Philippines, 1229
        • Research Site
      • Quezon City, Philippines, 1100
        • Research Site
  • Poland
      • Białystok, Poland, 15-276
        • Research Site
      • Olsztyn, Poland, 10-357
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
      • Warszawa, Poland, 04-141
        • Research Site
  • Romania
      • Suceava, Romania, 720237
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Research Site
      • Krasnoyarsk, Russian Federation, 660133
        • Research Site
      • Moscow, Russian Federation, 121205
        • Research Site
      • Moscow, Russian Federation, 105229
        • Research Site
      • Moscow, Russian Federation, 115280
        • Research Site
      • Moscow, Russian Federation, 115008
        • Research Site
      • Nizhniy Novgorod, Russian Federation, 603081
        • Research Site
      • Obninsk, Russian Federation, 249036
        • Research Site
      • Rostov-on-Don, Russian Federation, 344037
        • Research Site
      • St. Petersburg, Russian Federation, 197022
        • Research Site
      • Tomsk, Russian Federation, 634063
        • Research Site
      • Yaroslavl, Russian Federation, 150054
        • Research Site
  • Spain
      • Alicante, Spain, 03010
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Oviedo, Spain, 33011
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • San Sebastian, Spain, 20014
        • Research Site
      • Santiago De Compostela (A Coruña), Spain, 15706
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung City, Taiwan, 402
        • Research Site
      • Tainan City, Taiwan, 70403
        • Research Site
      • Tainan City, Taiwan, 73657
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei City, Taiwan, 110
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10300
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Chiang Rai, Thailand, 57000
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Lampang, Thailand, 52000
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Research Site
      • Lexington, Kentucky, United States, 40513
        • Research Site
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Research Site
      • Towson, Maryland, United States, 21204
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Research Site
      • Minneapolis, Minnesota, United States, 55404
        • Research Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Research Site
      • New York, New York, United States, 10028
        • Research Site
      • Shirley, New York, United States, 11967
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Research Site
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Research Site
      • Charleston, South Carolina, United States, 29424
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Fort Worth, Texas, United States, 76104
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • Research Site
      • Seattle, Washington, United States, 98109
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh, Vietnam, 700000
        • Research Site
      • Ho Chi Minh, Vietnam, 70000
        • Research Site
      • Ho Chi Minh, Vietnam, 10000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
  • World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
  • At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
  • No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
  • Adequate organ and marrow function
  • Confirmation of a patient's tumour PD-L1 status
  • Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
  • Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

Exclusion Criteria:

  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
  • History of another primary malignancy
  • History of active primary immunodeficiency
  • Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
  • Deemed unresectable NSCLC by multidisciplinary evaluation
  • Patients who have pre-operative radiotherapy treatment as part of their care plan
  • Patients who have brain metastases or spinal cord compression
  • Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
  • Known allergy or hypersensitivity to any of the study drugs or excipients
  • Existence of more than one primary tumour such as mixed small cell and NSCLC histology
  • Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
  • Patients with a documented test result confirming the presence of EGFRm or ALK translocation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Durvalumab with platinum-based chemotherapy

Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity

The platinum-based chemotherapy will be based on tumour histology and Investigator discretion:

  • cisplatin with pemetrexed
  • carboplatin with pemetrexed
  • carboplatin with paclitaxel
  • cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
Drug: Durvalumab
1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Other Names:
  • MEDI4736
Drug: Cisplatin
75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
Drug: Pemetrexed
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Drug: Paclitaxel
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Drug: Gemcitabine
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
Drug: Carboplatin
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
Procedure: Surgery
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.
Placebo Comparator: Arm 2: Placebo with platinum-based chemotherapy

Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity

The platinum-based chemotherapy will be based on tumour histology and Investigator discretion:

  • cisplatin with pemetrexed
  • carboplatin with pemetrexed
  • carboplatin with paclitaxel
  • cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
Drug: Cisplatin
75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
Drug: Pemetrexed
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Drug: Paclitaxel
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Drug: Gemcitabine
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
Other: Placebo
Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Drug: Carboplatin
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
Procedure: Surgery
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
Time Frame: Up to approximately 15 weeks after randomization
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Up to approximately 15 weeks after randomization
Event-Free Survival (EFS) in modified intent to treat (mITT) population
Time Frame: Up to 5.5 years after first patient randomized.
An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
Up to 5.5 years after first patient randomized.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of ADA for durvalumab
Time Frame: From date of randomization to 3 months after last dose of IP
To evaluate the presence of antibodies following treatment with study medications.
From date of randomization to 3 months after last dose of IP
Disease-free survival (DFS) in modified resected population
Time Frame: From date of randomization to approximately 5.5 years after date of resection
From date of randomization to approximately 5.5 years after date of resection
Major Pathological Response (mPR) in modified intent to treat (mITT) population
Time Frame: Up to approximately 15 weeks after randomization
Up to approximately 15 weeks after randomization
Overall Survival (OS) in modified intent to treat (mITT) population
Time Frame: From date of randomization to 5.5 years after randomization
From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time Frame: From date of randomization to 5.5 years after randomization
From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time Frame: Up to approximately 15 weeks after randomization
Up to approximately 15 weeks after randomization
Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
Time Frame: From date of randomization to 5.5 years after date of resection
From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time Frame: Up to approximately 15 weeks after randomization
Up to approximately 15 weeks after randomization
Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time Frame: From date of randomization to 5.5 years after randomization.
From date of randomization to 5.5 years after randomization.
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
Time Frame: From date of screening to 6 months after last dose of IP
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
From date of screening to 6 months after last dose of IP
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
Time Frame: From date of screening to 6 months after last dose of IP
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
From date of screening to 6 months after last dose of IP
To assess the PK of durvalumab in blood
Time Frame: From date of randomization to 2 months after resection
To assess concentration of durvalumab in bloodstream.
From date of randomization to 2 months after resection

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events as assessed by CTCAE v5.0
Time Frame: From date of randomization to 3 months after last dose of IP
From date of randomization to 3 months after last dose of IP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: John Heymach, MD, UT MD Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

November 10, 2022

Study Completion (Estimated)

September 11, 2028

Study Registration Dates

First Submitted

December 7, 2018

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9106C00001
  • 2018-002997-29 (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 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 Pharma Data Sharing Principles. For details of our timelines, please refer 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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