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NCT05061550From ClinicalTrials.govRecruiting

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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Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer | Trialion