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Treatment for early-stage non-small cell lung cancer before and after surgery

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)

PHASE2 · AstraZeneca · NCT05061550

This study is testing different combinations of immunotherapy and chemotherapy for people with early-stage non-small cell lung cancer to see if they can improve outcomes and lower the chances of cancer coming back after surgery.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment630 (estimated)
Ages18 Years to 95 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionschemotherapy, Durvalumab, Oleclumab, Monalizumab, Datopotamab
Locations99 sites (Little Rock, Arkansas and 98 other locations)
Trial IDNCT05061550 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of various combinations of immunotherapy and chemotherapy in patients with resectable early-stage non-small cell lung cancer (NSCLC). Participants will be randomly assigned to receive different treatment regimens that include drugs like Durvalumab, Oleclumab, and Monalizumab, either before surgery (neoadjuvant) or after surgery (adjuvant). The study aims to determine the best approach to improve patient outcomes and reduce the risk of cancer recurrence.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed patients with resectable NSCLC at stages IIA to IIIB and a good performance status.

Not a fit: Patients with specific genetic mutations such as sensitising EGFR mutations or ALK translocations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with early-stage NSCLC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in lung cancer, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 limit compliance with study requirement.
* History of another primary malignancy.
* Participants with small-cell lung cancer or mixed small-cell lung cancer.
* History of active primary immunodeficiency.
* History of non-infectious interstitial lung disease (ILD) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Participants who have preoperative radiotherapy treatment as part of their care plan.
* Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
* QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
* Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
* Participants with moderate or severe cardiovascular disease.
* Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
* Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
* Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
* Active or uncontrolled infections including HBA, HBV, HCV, and HIV.

Where this trial is running

Little Rock, Arkansas and 98 other locations

+49 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer, Lung Cancer, early-stage, Durvalumab, Oleclumab, Monalizumab, AZD0171, Datopotamab Deruxtecan

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.