NCT05061550 · AstraZeneca
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
(NeoCOAST-2)
What this study is about
The study is intended to assess the safety and effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Durvalumab
Participants will receive Durvalumab via intravenous route.
DRUG
Oleclumab
Participants will receive Oleclumab via intravenous route.
DRUG
Monalizumab
Participants will receive Monalizumab via intravenous route.
DRUG
Dato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
DRUG
AZD0171
Participants will receive AZD0171 via intravenous route.
DRUG
Carboplatin
Carboplatin as chemotherapy
DRUG
Cisplatin
Cisplatin as chemotherapy
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.
DRUG
Rilvegostomig
Participants will receive Rilvegostomig via intravenous route.
Primary outcome measures
Number of participants with pathological complete response (pCR)
Time frame: From randomization to approximately 15 weeks after the first dose of study interventions
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Until Day 90 after the last dose of study interventions (Up to approximately 3 years)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 with baseline PD-L1 expression status \<1% (Arms 6 and 7 only).
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would
Where
- Little Rock, Arkansas
- Los Angeles, California
- Oakland, California
- New Haven, Connecticut
- Stuart, Florida
- Gainesville, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Saint Louis Park, Minnesota
- Omaha, Nebraska
- Buffalo, New York
And 9 more locations — see the full list below.
Collaborators
Parexel
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations