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RECRUITING

NCT05061550

PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

630

Start Date

2022-04-14

Completion Date

2030-05-28

Last Updated

2026-03-11

Healthy Volunteers

Conditions

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.

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.

Locations (99)

Research Site

Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Oakland, California, United States

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New Haven, Connecticut, United States

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Stuart, Florida, United States

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Gainesville, Georgia, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Saint Louis Park, Minnesota, United States

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Omaha, Nebraska, United States

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Buffalo, New York, United States

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Cleveland, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Edmonds, Washington, United States

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Seattle, Washington, United States

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Ghent, Belgium

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Ghent, Belgium

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Gilly, Belgium

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Leuven, Belgium

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Roeselare, Belgium

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Avignon, France

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Bobigny, France

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Bordeaux, France

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Limoges, France

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Rennes, France

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Rouen, France

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Suresnes, France

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Toulon, France

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Kecskemét, Hungary

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Székesfehérvár, Hungary

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Tatabánya, Hungary

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Törökbálint, Hungary

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Dublin, Ireland

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Dublin, Ireland

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Dublin, Ireland

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Galway, Ireland

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Aviano, Italy

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Brescia, Italy

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Catanzaro, Italy

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Florence, Italy

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Genova, Italy

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Meldola, Italy

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Milan, Italy

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Monza, Italy

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Padova, Italy

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Perugia, Italy

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Pisa, Italy

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Roma, Italy

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Rozzano, Italy

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Lisbon, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Porto, Portugal

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Porto, Portugal

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Busan, South Korea

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Chungcheongbuk-do, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Suwon, South Korea

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A Coruña, Spain

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Alicante, Spain

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Barcelona, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Majadahonda, Spain

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Málaga, Spain

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Reus, Spain

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Seville, Spain

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Terrassa, Spain

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Valencia, Spain

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Liuying, Taiwan

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New Taipei City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (99)