A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)
Who is this study for? Patients with resectable, early-stage non-small cell lung cancer
Status: Recruiting
Location: See all (98) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:
• Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
• WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ and bone marrow function.
• Provision of tumour samples (newly acquired or archival tumour tissue \[≤ 6 months old\]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
• Adequate pulmonary function.
Locations
United States
Arkansas
Research Site
RECRUITING
Little Rock
California
Research Site
RECRUITING
Los Angeles
Research Site
WITHDRAWN
Oakland
Connecticut
Research Site
RECRUITING
New Haven
Florida
Research Site
COMPLETED
Stuart
Georgia
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COMPLETED
Gainesville
Illinois
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RECRUITING
Chicago
Massachusetts
Research Site
RECRUITING
Boston
Maryland
Research Site
WITHDRAWN
Baltimore
Research Site
RECRUITING
Baltimore
Minnesota
Research Site
COMPLETED
Saint Louis Park
Nebraska
Research Site
NOT_YET_RECRUITING
Omaha
New York
Research Site
RECRUITING
Buffalo
Ohio
Research Site
RECRUITING
Cleveland
Pennsylvania
Research Site
RECRUITING
Pittsburgh
Tennessee
Research Site
RECRUITING
Chattanooga
Research Site
RECRUITING
Memphis
Research Site
RECRUITING
Nashville
Research Site
NOT_YET_RECRUITING
Nashville
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RECRUITING
Nashville
Texas
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RECRUITING
Houston
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RECRUITING
Houston
Virginia
Research Site
RECRUITING
Fairfax
Washington
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RECRUITING
Seattle
Other Locations
Belgium
Research Site
RECRUITING
Charleroi
Research Site
COMPLETED
Ghent
Research Site
RECRUITING
Ghent
Research Site
COMPLETED
Leuven
Research Site
RECRUITING
Roeselare
Canada
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COMPLETED
Edmonton
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RECRUITING
Montreal
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RECRUITING
Montreal
Research Site
RECRUITING
Winnipeg
France
Research Site
RECRUITING
Avignon
Research Site
WITHDRAWN
Bobigny
Research Site
COMPLETED
Bordeaux
Research Site
RECRUITING
Limoges
Research Site
RECRUITING
Rennes
Research Site
RECRUITING
Rouen
Research Site
RECRUITING
Suresnes
Research Site
RECRUITING
Toulon
Hungary
Research Site
RECRUITING
Kecskemét
Research Site
RECRUITING
Székesfehérvár
Research Site
COMPLETED
Tatabánya
Research Site
RECRUITING
Törökbálint
Ireland
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RECRUITING
Dublin
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RECRUITING
Dublin
Research Site
RECRUITING
Dublin
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RECRUITING
Galway
Italy
Research Site
RECRUITING
Aviano
Research Site
RECRUITING
Brescia
Research Site
WITHDRAWN
Catanzaro
Research Site
RECRUITING
Florence
Research Site
RECRUITING
Genova
Research Site
RECRUITING
Meldola
Research Site
RECRUITING
Milan
Research Site
RECRUITING
Monza
Research Site
RECRUITING
Padua
Research Site
RECRUITING
Perugia
Research Site
RECRUITING
Pisa
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RECRUITING
Roma
Research Site
RECRUITING
Rozzano
Portugal
Research Site
RECRUITING
Lisbon
Research Site
RECRUITING
Lisbon
Research Site
RECRUITING
Lisbon
Research Site
RECRUITING
Lisbon
Research Site
WITHDRAWN
Porto
Research Site
COMPLETED
Porto
Research Site
RECRUITING
Porto
Republic of Korea
Research Site
COMPLETED
Busan
Research Site
WITHDRAWN
Chungcheongbuk-do
Research Site
RECRUITING
Seongnam-si
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Suwon
Research Site
RECRUITING
Suwon
Spain
Research Site
RECRUITING
A Coruña
Research Site
RECRUITING
Alicante
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Córdoba
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Majadahonda
Research Site
RECRUITING
Málaga
Research Site
RECRUITING
Reus
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Terrassa
Research Site
RECRUITING
Valencia
Taiwan
Research Site
RECRUITING
Liuying
Research Site
RECRUITING
New Taipei City
Research Site
RECRUITING
Tainan City
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Turkey
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Istanbul
Research Site
RECRUITING
Izmir
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Backup
AstraZeneca Lung Cancer Study Locator Service
az-lcsl@careboxhealth.com
1-884-432-3892
Time Frame
Start Date: 2022-04-14
Estimated Completion Date: 2030-05-09
Participants
Target number of participants: 630
Treatments
Experimental: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:~Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Experimental: Arm 2: Monalizumab + Durvalumab + CTX
Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:~Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Experimental: Arm 3: Volrustomig (Dose Exploration) + CTX
Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:~Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Experimental: Arm 4: Dato-DXd + durvalumab + single agent platinum
Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery:~Carboplatin or Cisplatin
Experimental: Arm 5: AZD0171 + durvalumab + CTX
Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:~Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Experimental: Arm 6: Rilvegostomig + CTX
Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:~Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Experimental: Arm 7: Dato-DXd + Rilvegostomig + single agent platinum
Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.~Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery:~Carboplatin or Cisplatin
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Parexel