At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed NSCLC with resectable disease (Stage IIA to Stage IIIB)
- ✓WHO or ECOG performance status 0 or 1
- ✓Adequate organ and bone marrow function
- ✓Tumour samples (newly acquired or archival ≤6 months old) to confirm PD-L1, EGFR, or ALK status
- ✕Sensitising EGFR mutations or ALK translocations
- ✕Baseline PD-L1 expression <1% (Arms 6 and 7 only)
- ✕Active or prior documented autoimmune or inflammatory disorders
- ✕Uncontrolled intercurrent illness including hypertension, angina, cardiac arrhythmia, active bleeding, chronic GI conditions with diarrhoea, psychiatric illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Oleclumab, and 10 other interventions for Non-small Cell Lung Cancer. Currently recruiting, targeting 630 participants across 97 sites in 12 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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
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
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
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
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
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
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
Interventions
Participants will receive Durvalumab via intravenous route.
Participants will receive Oleclumab via intravenous route.
Participants will receive Monalizumab via intravenous route.
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
Participants will receive AZD0171 via intravenous route.
Carboplatin as chemotherapy
Cisplatin as chemotherapy
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel, as chemotherapy
Participants will receive Volrustomig via intravenous route.
Participants will receive Rilvegostomig via intravenous route.