NCT05061550RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 630 (estimated)
- First submitted
- 20 Sept 2021
- Start date
- 14 Apr 2022
- Primary completion date
- 28 May 2030
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer
- NCT number
- NCT05061550
- EU CT number
- 2023-508852-21-00
- EudraCT number
- 2021-003369-37
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 630
- From 14 Apr 2022 to the primary completion date, 28 May 2030
- 86 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune or inflammatory disorders.
- 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.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- 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.
Other illness
- 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 with moderate or severe cardiovascular disease.
- Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
Lab values
- Participants with sensitising EGFR mutations or ALK translocations.
- QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
Other
- Participants with baseline PD-L1 expression status \<1% (Arms 6 and 7 only).
Who the study is looking for
- 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.
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (86)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| AZ Sint-Lucas & Volkskliniek Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Edmonton | Canada | Completed |
| Research Site Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Salut Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| HIA Sainte Anne Coordinator of this site? Confirm its status | Toulon Cedex 9 | France | Recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Recruiting |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Recruiting |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Recruiting |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Recruiting |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Recruiting |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Recruiting |
| University Hospital Galway Coordinator of this site? Confirm its status | Galway | Ireland | Recruiting |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| University Hospital Of Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Busan | South Korea | Completed |
| Research Site Coordinator of this site? Confirm its status | Chungcheongbuk-do | South Korea | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital da Luz, S.A Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Champalimaud Clinical Centre Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Liuying | Taiwan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Baltimore | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Buffalo | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Chattanooga | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Edmonds | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Gainesville | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Nashville | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Oakland | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Saint Louis Park | United States | Completed |
| Research Site Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Stuart | United States | Completed |
| Research Site Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.