Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
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
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 630
- Started
- 14 April 2022
- Main results due
- 28 May 2030
- Study sites
- 97
- Registry updated
- 23 September 2026
Can you take part?
- Ages 18 years to 95 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(97)
Research Site
Little Rock, Arkansas, United States
Recruiting
Research Site
Los Angeles, California, United States
Recruiting
Research Site
Oakland, California, United States
Withdrawn
Research Site
New Haven, Connecticut, United States
Recruiting
Research Site
Stuart, Florida, United States
Completed
Research Site
Gainesville, Georgia, United States
Withdrawn
Research Site
Chicago, Illinois, United States
Recruiting
Research Site
Baltimore, Maryland, United States
Withdrawn
Research Site
Baltimore, Maryland, United States
Recruiting
Research Site
Boston, Massachusetts, United States
Recruiting
Research Site
Saint Louis Park, Minnesota, United States
Completed
Research Site
Omaha, Nebraska, United States
Recruiting
Research Site
Buffalo, New York, United States
Recruiting
Research Site
Cleveland, Ohio, United States
Recruiting
Research Site
Pittsburgh, Pennsylvania, United States
Recruiting
Research Site
Chattanooga, Tennessee, United States
Recruiting
Research Site
Memphis, Tennessee, United States
Recruiting
Research Site
Nashville, Tennessee, United States
Withdrawn
Research Site
Nashville, Tennessee, United States
Recruiting
Research Site
Nashville, Tennessee, United States
Recruiting
Research Site
Houston, Texas, United States
Recruiting
Research Site
Houston, Texas, United States
Terminated
Research Site
Fairfax, Virginia, United States
Recruiting
Research Site
Edmonds, Washington, United States
Recruiting
Research Site
Seattle, Washington, United States
Recruiting
Research Site
Ghent, Belgium
Recruiting
Research Site
Ghent, Belgium
Completed
Research Site
Roeselare, Belgium
Recruiting
Research Site
Edmonton, Alberta, Canada
Completed
Research Site
Winnipeg, Manitoba, Canada
Recruiting
Research Site
Montreal, Quebec, Canada
Recruiting
Research Site
Montreal, Quebec, Canada
Recruiting
Research Site
Avignon, France
Recruiting
Research Site
Bobigny, France
Withdrawn
Research Site
Bordeaux, France
Recruiting
Research Site
Limoges, France
Recruiting
Research Site
Rennes, France
Recruiting
Research Site
Rouen, France
Recruiting
Research Site
Suresnes, France
Recruiting
Research Site
Toulon, France
Recruiting
Research Site
Kecskemét, Hungary
Recruiting
Research Site
Székesfehérvár, Hungary
Recruiting
Research Site
Tatabánya, Hungary
Completed
Research Site
Törökbálint, Hungary
Recruiting
Research Site
Dublin, Ireland
Recruiting
Research Site
Dublin, Ireland
Recruiting
Research Site
Dublin, Ireland
Recruiting
Research Site
Galway, Ireland
Recruiting
Research Site
Aviano, Italy
Recruiting
Research Site
Brescia, Italy
Recruiting
Research Site
Catanzaro, Italy
Withdrawn
Research Site
Florence, Italy
Recruiting
Research Site
Genova, Italy
Recruiting
Research Site
Meldola, Italy
Recruiting
Research Site
Milan, Italy
Recruiting
Research Site
Monza, Italy
Recruiting
Research Site
Padova, Italy
Recruiting
Research Site
Perugia, Italy
Recruiting
Research Site
Pisa, Italy
Recruiting
Research Site
Roma, Italy
Recruiting
Showing 60 of 97 sites — filter to narrow it down. 81 of the 97 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05061550. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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