Study identifier:D9077C00001
ClinicalTrials.gov identifier:NCT05061550
EudraCT identifier:2021-003369-37
CTIS identifier:2023-508852-21-00
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, Rilvegostomig
All
630
Interventional
18 Years - 95 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
Parexel International
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.
This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens. Arm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment. Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment. Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment. Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Arm 6: Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Arm 7: Participants will receive Dato-DXd + Rilvegostomig + single agent platinum chemotherapy as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.
Location
Status
Location
Baltimore, MD, United States, 21231
Status
Recruiting
Location
Suresnes, France, 92150
Status
Recruiting
Location
Limoges, France, 83000
Status
Recruiting
Location
Bordeaux, France, 33076
Status
Completed
Location
Rennes Cedex, France, 35000
Status
Recruiting
Location
Fairfax, VA, United States, 22031
Status
Recruiting
Location
Monza, Italy, 20900
Status
Recruiting
Location
Aviano, Italy, 33081
Status
Recruiting
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 |
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 | Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy Drug: Rilvegostomig Participants will receive Rilvegostomig via intravenous route. |
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 | Drug: Dato-DXd Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Drug: Carboplatin Carboplatin as chemotherapy Drug: Cisplatin Cisplatin as chemotherapy Drug: Rilvegostomig Participants will receive Rilvegostomig via intravenous route. |
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