RecruitingPhase 2NCT05061550

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)

Sponsor

AstraZeneca

Enrollment

630 participants

Start Date

Apr 14, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study tests different combinations of immunotherapy (including durvalumab, a checkpoint inhibitor) given before and after surgery for non-small cell lung cancer (NSCLC) that can still be removed surgically. The goal is to shrink the tumor before surgery and reduce the chance it comes back afterward. **You may be eligible if...** - You have newly diagnosed NSCLC that can be surgically removed (Stage IIA to IIIB) - You are in good overall health (ECOG 0–1) with adequate organ function - Tumor tissue is available to test for PD-L1, EGFR, and ALK markers **You may NOT be eligible if...** - Your tumor has EGFR mutations or ALK translocations (these patients have different targeted therapies) - You have a history of autoimmune disease or inflammatory disorders - You have small-cell lung cancer or mixed small-cell lung cancer - You have another active primary cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Participants will receive Durvalumab via intravenous route.

DRUGOleclumab

Participants will receive Oleclumab via intravenous route.

DRUGMonalizumab

Participants will receive Monalizumab via intravenous route.

DRUGDato-DXd

Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.

DRUGAZD0171

Participants will receive AZD0171 via intravenous route.

DRUGCarboplatin

Carboplatin as chemotherapy

DRUGCisplatin

Cisplatin as chemotherapy

DRUGPemetrexed/Cisplatin

Pemetrexed/Cisplatin as chemotherapy

DRUGPemetrexed/Carboplatin

Pemetrexed/Carboplatin as chemotherapy

DRUGCarboplatin/Paclitaxel

Carboplatin/Paclitaxel, as chemotherapy

DRUGVolrustomig

Participants will receive Volrustomig via intravenous route.

DRUGRilvegostomig

Participants will receive Rilvegostomig via intravenous route.

Locations(99)

Research Site

Little Rock, Arkansas, United States

Research Site

Los Angeles, California, United States

Research Site

Oakland, California, United States

Research Site

New Haven, Connecticut, United States

Research Site

Stuart, Florida, United States

Research Site

Gainesville, Georgia, United States

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Chicago, Illinois, United States

Research Site

Baltimore, Maryland, United States

Research Site

Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Saint Louis Park, Minnesota, United States

Research Site

Omaha, Nebraska, United States

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Buffalo, New York, United States

Research Site

Cleveland, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Chattanooga, Tennessee, United States

Research Site

Memphis, Tennessee, United States

Research Site

Nashville, Tennessee, United States

Research Site

Nashville, Tennessee, United States

Research Site

Nashville, Tennessee, United States

Research Site

Houston, Texas, United States

Research Site

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

Research Site

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

Research Site

Rouen, France

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Suresnes, France

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Toulon, France

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Kecskemét, Hungary

Research Site

Székesfehérvár, Hungary

Research Site

Tatabánya, Hungary

Research Site

Törökbálint, Hungary

Research Site

Dublin, Ireland

Research Site

Dublin, Ireland

Research Site

Dublin, Ireland

Research Site

Galway, Ireland

Research Site

Aviano, Italy

Research Site

Brescia, Italy

Research Site

Catanzaro, Italy

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Florence, Italy

Research Site

Genova, Italy

Research Site

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

Research Site

Lisbon, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

Research Site

Porto, Portugal

Research Site

Porto, Portugal

Research Site

Porto, Portugal

Research Site

Busan, South Korea

Research Site

Chungcheongbuk-do, South Korea

Research Site

Seongnam-si, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Suwon, South Korea

Research Site

Suwon, South Korea

Research Site

A Coruña, Spain

Research Site

Alicante, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Córdoba, Spain

Research Site

Madrid, Spain

Research Site

Majadahonda, Spain

Research Site

Málaga, Spain

Research Site

Reus, Spain

Research Site

Seville, Spain

Research Site

Terrassa, Spain

Research Site

Valencia, Spain

Research Site

Liuying, Taiwan

Research Site

New Taipei City, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Ankara, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Izmir, Turkey (Türkiye)

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NCT05061550

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