RecruitingPhase 1NCT04686305

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)

Sponsor

AstraZeneca

Enrollment

304 participants

Start Date

Mar 9, 2021

Study Type

INTERVENTIONAL

Summary

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety of combining T-DXd (trastuzumab deruxtecan, a targeted antibody-drug) with immunotherapy drugs, with or without chemotherapy, in people with HER2-overexpressing non-squamous non-small cell lung cancer (NSCLC) that cannot be surgically removed. **You may be eligible if...** - You are an adult with advanced or metastatic non-squamous NSCLC - Your tumor overexpresses HER2 (confirmed by central testing) - You are in good physical condition (ECOG 0–1) - For certain parts: you have already had 1–2 prior treatments, or your cancer has no other treatable driver mutations and you have not yet received treatment for advanced disease **You may NOT be eligible if...** - Your cancer has other treatable genetic mutations (such as EGFR or ALK) for which approved drugs are available - You have not met the prior therapy requirements for the specific part of the study you are enrolling in 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

DRUGT-DXd

T-DXd: administered as an IV infusion

BIOLOGICALDurvalumab

Durvalumab: administered as an IV infusion

DRUGCisplatin

Cisplatin: administered as an IV infusion

DRUGCarboplatin

Carboplatin: administered as an IV infusion

DRUGPemetrexed

Pemetrexed: administered as an IV infusion (drug not used)

DRUGVolrustomig

Volrustomig: administered as an IV infusion

DRUGRilvegostomig

Rilvegostomig: administered as an IV infusion

Locations(91)

Research Site

Duarte, California, United States

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Newport Beach, California, United States

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Orange, California, United States

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Santa Rosa, California, United States

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Westwood, Kansas, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Buffalo, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Tacoma, Washington, United States

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Adelaide, Australia

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Heidelberg, Australia

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Nedlands, Australia

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Edegem, Belgium

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Barretos, Brazil

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Porto Alegre, Brazil

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São Paulo, Brazil

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Winnipeg, Manitoba, Canada

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London, Ontario, Canada

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Montreal, Quebec, Canada

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Changchun, China

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Chengdu, China

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Fuzhou, China

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Shandong, China

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Shanghai, China

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Zhengzhou, China

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Bordeaux, France

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Dijon, France

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Pierre-Bénite, France

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Saint-Herblain, France

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Villejuif, France

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Kfar Saba, Israel

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Tel Litwinsky, Israel

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Milan, Italy

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Milan, Italy

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Monza, Italy

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Naples, Italy

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Padova, Italy

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George Town, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Kuching, Malaysia

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Amsterdam, Netherlands

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Bacolod, Philippines

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Cebu City, Philippines

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City of Taguig, Philippines

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Davao City, Philippines

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Manila, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Quezon City, Philippines

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San Juan City, Philippines

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Gdansk, Poland

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Krakow, Poland

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Olsztyn, Poland

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Tomaszów Mazowiecki, Poland

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Warsaw, Poland

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Cheongju-si, South Korea

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Goyang-si, South Korea

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Jinju, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Badalona, Spain

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Madrid, Spain

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Seville, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Hat Yai, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

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Muang, Thailand

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Bornova-Izmir, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT04686305