Study identifier:D9077C00001
ClinicalTrials.gov identifier:NCT05061550
EudraCT identifier:2021-003369-37
CTIS identifier:N/A
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)
Non-small Cell Lung Cancer
Phase 2
No
Durvalumab, Oleclumab, Monalizumab, Dato-DXd, AZD0171, Carboplatin, Cisplatin, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin, Carboplatin/Paclitaxel, Volrustomig
All
490
Interventional
18 Years - 95 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
Parexel International
No locations available
Arms | Assigned Interventions |
---|---|
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 | Drug: Durvalumab Participants will receive Durvalumab via intravenous route. Other Name: MEDI4736, IMFINZI Drug: Oleclumab Participants will receive Oleclumab via intravenous route. Other Name: MEDI9447 Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy |
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 | Drug: Durvalumab Participants will receive Durvalumab via intravenous route. Other Name: MEDI4736, IMFINZI Drug: Monalizumab Participants will receive Monalizumab via intravenous route. Other Name: IPH2201 Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy |
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 | Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy Drug: Volrustomig Participants will receive Volrustomig via intravenous route. Other Name: MEDI5752 |
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 | Drug: Durvalumab Participants will receive Durvalumab via intravenous route. Other Name: MEDI4736, IMFINZI Drug: Dato-DXd Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Drug: Carboplatin Carboplatin as chemotherapy Drug: Cisplatin Cisplatin as chemotherapy |
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 | Drug: Durvalumab Participants will receive Durvalumab via intravenous route. Other Name: MEDI4736, IMFINZI Drug: AZD0171 Participants will receive AZD0171 via intravenous route. Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy |