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)
AstraZeneca
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.
Description
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…
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Participants with sensitising EGFR mutations or ALK translocations. * Participants wit…
Interventions
- DrugDurvalumab
Participants will receive Durvalumab via intravenous route.
- DrugOleclumab
Participants will receive Oleclumab via intravenous route.
- DrugMonalizumab
Participants will receive Monalizumab via intravenous route.
- DrugDato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
- DrugAZD0171
Participants will receive AZD0171 via intravenous route.
- DrugCarboplatin
Carboplatin as chemotherapy
- DrugCisplatin
Locations (99)
- Research SiteLittle Rock, Arkansas
- Research SiteLos Angeles, California
- Research SiteOakland, California
- Research SiteNew Haven, Connecticut
- Research SiteStuart, Florida
- Research SiteGainesville, Georgia