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Lung cancer trial tests cocktail of new drugs against standard care

NCT ID NCT05633667

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests several new drug combinations in people with non-small-cell lung cancer. It includes three substudies: one for untreated advanced cancer, one for cancer that has progressed after prior treatment, and one for early-stage cancer that can be surgically removed. The goal is to see if these combinations shrink tumors or eliminate cancer cells better than current standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zimberelimab, domvanalimab, sacituzumab govitecan-hziy, etrumadenant, and standard chemotherapies (carboplatin, cisplatin, pemetrexed, paclitaxel, nab-paclitaxel)
What this could lead to
If successful, this could point toward more effective treatment combinations for lung cancer, potentially improving response rates and survival.
What could go wrong
This is a phase 2 trial with only 192 participants, so results may not apply to everyone. The combinations may cause side effects and might not outperform standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

192 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: All Substudies: * Histologically or cytologically documented non-small-cell lung cancer (NSCLC). * No known actionable genomic alterations for which targeted therapies are available. * Eastern cooperative oncology group (ECOG) performance status score of 0 or 1. * Measurable disease per response evaluation criteria in solid tumors. * Adequate hematologic and end-organ function. * Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception. Substudy 01: All Experimental arms * Stage IV NSCLC. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative. * PD-L1 status by central confirmation. * No prior systemic treatment for metastatic NSCLC. Substudy 02: All Experimental arms * Stage IV NSCLC. * In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration. Substudy 03: All Experimental arms * Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T\[3-4\]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8). * Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy. * PD-L1 status by central confirmation. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative. Key Exclusion Criteria: All Substudies: * Mixed small-cell lung cancer and NSCLC histology. * Active second malignancy. * Active autoimmune disease. * History of or current non-infectious pneumonitis/interstitial lung disease. * Active serious infection within 4 weeks prior to study treatment. Substudy 01 and 02 * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Received previous anticancer therapy within 4 weeks prior to enrollment. Substudy 03: All Experimental arms * NSCLC previously treated with systemic therapy or radiotherapy. * Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs). Note: Other protocol defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic non-small cell lung cancer Lung cancer Resectable non-small cell lung cancer

Contacts and locations

Locations

  • Adana City Training and Research Hospital,Substudy-01

    Adana, 01120, Turkey (Türkiye)

  • Arizona Oncology Associates,Substudy-02

    Tucson, Arizona, 85711, United States

  • Asan Medical Center,Substudy-02

    Seoul, 05505, South Korea

  • Asan Medical Center,Substudy-03

    Seoul, 05505, South Korea

  • Asan Medical Centre,Substudy-01

    Seoul, 05505, South Korea

  • BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01

    São Paulo, 1509, Brazil

  • Baptist Health Lexington,Substudy-03

    Lexington, Kentucky, 40503, United States

  • Birmingham Heartlands Hospital,Substudy-03

    Birmingham, B9 5SS, United Kingdom

  • Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03

    Porto Alegre, 90110-270, Brazil

  • Changhua Christian Hospital,Substudy-01

    Changhua, 500-06, Taiwan

  • Changhua Christian Hospital,Substudy-02

    Changhua, 500-06, Taiwan

  • Changhua Christian Hospital,Substudy-03

    Changhua, 500-06, Taiwan

  • Chonnam National University Hwasun Hospital,Substudy-01

    Gwangju, 61469, South Korea

  • Chonnam National University Hwasun Hospital,Substudy-03

    Gwangju, 61469, South Korea

  • Chungbuk National University Hospital,Substudy-01

    Cheongju-si, 28644, South Korea

  • Chungbuk National University Hospital,Substudy-02

    Cheongju-si, 28644, South Korea

  • Dicle University Medical Faculty,Substudy-03

    Diyarbakır, 21280, Turkey (Türkiye)

  • Dicle University,Substudy-01

    Diyarbakır, 21100, Turkey (Türkiye)

  • Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03

    Fort Wayne, Indiana, 46845, United States

  • Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01

    São Paulo, 1509, Brazil

  • Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03

    São Paulo, 1509, Brazil

  • Fundação Pio XII - Hospital de Amor,Substudy-01

    Barretos, 14784-400, Brazil

  • Gazi University Medical Faculty,Substudy-01

    Yenimahalle, Turkey (Türkiye)

  • Gazi University Medical Faculty,Substudy-03

    Yenimahalle, Turkey (Türkiye)

  • Hadassah Medical Center,Substudy-01

    Jerusalem, 91120, Israel

  • Hadassah University Medical Center,Substudy-03

    Jerusalem, 91120, Israel

  • Hospital Mae de Deus

    Porto Alegre, 90110-270, Brazil

  • Hospital Mae de Deus,Substudy-01

    Porto Alegre, 90110-270, Brazil

  • Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01

    Porto Alegre, 90610001, Brazil

  • Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03

    Porto Alegre, 90610001, Brazil

  • Kaohsiung Chang Gung Memorial Hospital,Substudy-01

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Chang Gung Memorial Hospital,Substudy-02

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Chang Gung Memorial Hospital,Substudy-03

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03

    Kaohsiung City, 80756, Taiwan

  • Korea University Guro Hospital,Substudy-01

    Seoul, 8308, South Korea

  • Korea University Guro Hospital,Substudy-03

    Seoul, 8308, South Korea

  • Kosin University Gospel Hospital,Substudy-01

    Seogu, 49267, South Korea

  • Kosin University Gospel Hospital,Substudy-03

    Seogu, 49267, South Korea

  • Medical Park Samsun,Substudy-01

    Atakum, 55200, Turkey (Türkiye)

  • Memorial Ankara Hastanesi,Substudy-01

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Ankara Hospital,Substudy-03

    Ankara, 06520, Turkey (Türkiye)

  • National Cancer Center,Substudy-01

    Goyang, 410769, South Korea

  • National Cancer Center,Substudy-02

    Goyang, 410769, South Korea

  • National Cancer Center,Substudy-03

    Goyang, 410769, South Korea

  • National Taiwan University Hospital,Substudy-01

    Taipei, 100, Taiwan

  • National Taiwan University Hospital,Substudy-02

    Taipei, 100, Taiwan

  • Necmettin Erbakan Universitesi,Substudy-03

    Meram Konya, 42080, Turkey (Türkiye)

  • Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01

    Konya, 42080, Turkey (Türkiye)

  • Oncology Associates of Oregon, PC,Substudy-01

    Eugene, Oregon, 97401, United States

  • Oncology Associates of Oregon, PC,Substudy-02

    Eugene, Oregon, 97401, United States

  • Oncology Hematology Care Clinical Trials, LLC,Substudy-01

    Cincinnati, Ohio, 45242, United States

  • Oncology Hematology Care Clinical Trials, LLC,Substudy-02

    Cincinnati, Ohio, 45242, United States

  • Prince of Wales Hospital,Substudy-01

    New Territories, Hong Kong

  • Prince of Wales Hospital,Substudy-02

    New Territories, Hong Kong

  • Queen Elizabeth Hospital,Substudy-01

    Hong Kong, Hong Kong

  • Queen Elizabeth Hospital,Substudy-02

    Hong Kong, Hong Kong

  • Queen Mary Hospital,Substudy-01

    Hong Kong, 999077, Hong Kong

  • Queen Mary Hospital,Substudy-02

    Hong Kong, 999077, Hong Kong

  • Rambam Health Care Campus,Substudy-01

    Haifa, 3525408, Israel

  • Rambam Health Care Campus,Substudy-02

    Haifa, 3525408, Israel

  • Rambam Health Care Campus,Substudy-03

    Haifa, 3525408, Israel

  • Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03

    São Paulo, 1509, Brazil

  • Samsung Medical Center,Substudy-01

    Seoul, 06351, South Korea

  • Samsung Medical Center,Substudy-02

    Seoul, 06351, South Korea

  • Samsung Medical Center,Substudy-03

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital,Substudy-01

    Gyeonggi-do, 463-707, South Korea

  • Seoul National University Bundang Hospital,Substudy-03

    Gyeonggi-do, 463-707, South Korea

  • Seoul National University,Substudy-02

    Seoul, 463-707, South Korea

  • Severance Hospital, Yonsei University Health System,Substudy-01

    Seoul, 120-752, South Korea

  • Severance Hospital, Yonsei University Health System,Substudy-02

    Seoul, 120-752, South Korea

  • Severance Hospital, Yonsei University Health System,Substudy-03

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center,Substudy-01

    Jerusalem, 9103102, Israel

  • Shaare Zedek Medical Center,Substudy-02

    Jerusalem, 9103102, Israel

  • Shaare Zedek Medical Center,Substudy-03

    Jerusalem, 9103102, Israel

  • St James University Hospital,,Substudy-01

    Leeds, LS9 7TF, United Kingdom

  • St. Bartholomew's Hospital,Substudy-01

    London, E1 1BB, United Kingdom

  • St. Bartholomew's Hospital,Substudy-02

    London, E1 1BB, United Kingdom

  • St. Bartholomew's Hospital,Substudy-03

    London, E1 1BB, United Kingdom

  • Tel Aviv Sourasky Medical Center,Substudy-01

    Tel Aviv, 64239, Israel

  • Tel Aviv Sourasky Medical Center,Substudy-02

    Tel Aviv, 64239, Israel

  • Tel-Aviv Sourasky Medical Center,Substudy-03

    Tel Aviv, 64239, Israel

  • University Hospitals Birmingham NHS Trust,Substudy-01

    Birmingham, B9 5SS, United Kingdom

  • University Hospitals Birmingham NHS Trust,Substudy-02

    Birmingham, B9 5SS, United Kingdom

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine - Siteman Cancer Center,Substudy-01

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine - Siteman Cancer Center,Substudy-02

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine - Siteman Cancer Center,Substudy-03

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.