Study of Novel Treatment Combinations in Patients With Lung Cancer
NCT ID: NCT05633667
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
593 participants
INTERVENTIONAL
2023-03-16
2029-09-30
Brief Summary
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The primary objectives of this study are:
Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Zimberelimab (ZIM)
Administered intravenously
Domvanalimab (DOM)
Administered intravenously
Sacituzumab govitecan-hziy (SG)
Administered intravenously
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Zimberelimab (ZIM)
Administered intravenously
Domvanalimab (DOM)
Administered intravenously
Etrumadenant (ETRUMA)
Administered orally
Substudy 01: ZIM + ETRUMA
Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Zimberelimab (ZIM)
Administered intravenously
Etrumadenant (ETRUMA)
Administered orally
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)
Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Zimberelimab (ZIM)
Administered intravenously
Sacituzumab govitecan-hziy (SG)
Administered intravenously
Substudy 01: ZIM + Platinum Based Chemotherapy
Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology).
Zimberelimab (ZIM)
Administered intravenously
Carboplatin
Administered intravenously
Cisplatin
Administered intravenously
Pemetrexed
Administered intravenously
Paclitaxel
Administered intravenously
Nab-paclitaxel
Administered intravenously
Substudy 02: SG + ZIM + ETRUMA
Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Zimberelimab (ZIM)
Administered intravenously
Sacituzumab govitecan-hziy (SG)
Administered intravenously
Etrumadenant (ETRUMA)
Administered orally
Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Sacituzumab govitecan-hziy (SG)
Administered intravenously
Docetaxel
Administered intravenously
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Zimberelimab (ZIM)
Administered intravenously
Domvanalimab (DOM)
Administered intravenously
Carboplatin
Administered intravenously
Pemetrexed
Administered intravenously
Paclitaxel
Administered intravenously
Substudy 03 - ZIM + Platinum-based Chemotherapy
Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Zimberelimab (ZIM)
Administered intravenously
Carboplatin
Administered intravenously
Pemetrexed
Administered intravenously
Paclitaxel
Administered intravenously
Substudy 03: Nivolumab + Platinum-based Chemotherapy
Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Carboplatin
Administered intravenously
Pemetrexed
Administered intravenously
Paclitaxel
Administered intravenously
Nivolumab
Administered intravenously
Interventions
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Zimberelimab (ZIM)
Administered intravenously
Domvanalimab (DOM)
Administered intravenously
Sacituzumab govitecan-hziy (SG)
Administered intravenously
Etrumadenant (ETRUMA)
Administered orally
Carboplatin
Administered intravenously
Cisplatin
Administered intravenously
Pemetrexed
Administered intravenously
Paclitaxel
Administered intravenously
Nab-paclitaxel
Administered intravenously
Docetaxel
Administered intravenously
Nivolumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Arizona Oncology Associates,Substudy-01
Tucson, Arizona, United States
Arizona Oncology Associates,Substudy-02
Tucson, Arizona, United States
Rocky Mountain Cancer Center,Substudy-01
Denver, Colorado, United States
Rocky Mountain Cancer Center,Substudy-02
Denver, Colorado, United States
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne, Indiana, United States
Baptist Health Lexington,Substudy-03
Lexington, Kentucky, United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Cincinnati, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Cincinnati, Ohio, United States
Oncology Associates of Oregon, PC,Substudy-01
Eugene, Oregon, United States
Oncology Associates of Oregon, PC,Substudy-02
Eugene, Oregon, United States
Texas Oncology - Central South,Substudy-01
Austin, Texas, United States
Texas Oncology - Central South,Substudy-02
Austin, Texas, United States
US Oncology Investigational Products Center (IPC),Substudy-01
Fairfax, Virginia, United States
US Oncology Investigational Products Center (IPC),Substudy-02
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center,Substudy-01
Seattle, Washington, United States
Fred Hutchinson Cancer Center,Substudy-02
Seattle, Washington, United States
Fundação Pio XII - Hospital de Amor,Substudy-01
Barretos, , Brazil
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
Porto Alegre, , Brazil
Hospital Mae de Deus,Substudy-01
Porto Alegre, , Brazil
Hospital Mae de Deus
Porto Alegre, , Brazil
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01
Porto Alegre, , Brazil
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
Porto Alegre, , Brazil
BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01
São Paulo, , Brazil
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
São Paulo, , Brazil
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
São Paulo, , Brazil
Queen Mary Hospital,Substudy-01
Hong Kong, , Hong Kong
Queen Mary Hospital,Substudy-02
Hong Kong, , Hong Kong
Queen Elizabeth Hospital,Substudy-01
Hong Kong, , Hong Kong
Queen Elizabeth Hospital,Substudy-02
Hong Kong, , Hong Kong
Prince of Wales Hospital,Substudy-01
New Territories, , Hong Kong
Prince of Wales Hospital,Substudy-02
New Territories, , Hong Kong
Rambam Health Care Campus,Substudy-01
Haifa, , Israel
Rambam Health Care Campus,Substudy-02
Haifa, , Israel
Rambam Health Care Campus,Substudy-03
Haifa, , Israel
Shaare Zedek Medical Center,Substudy-01
Jerusalem, , Israel
Shaare Zedek Medical Center,Substudy-02
Jerusalem, , Israel
Shaare Zedek Medical Center,Substudy-03
Jerusalem, , Israel
Hadassah Medical Center,Substudy-01
Jerusalem, , Israel
Hadassah University Medical Center,Substudy-03
Jerusalem, , Israel
Rabin Medical Center,Substudy-03
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center,Substudy-01
Tel Aviv, , Israel
Tel Aviv Sourasky Medical Center,Substudy-02
Tel Aviv, , Israel
Tel-Aviv Sourasky Medical Center,Substudy-03
Tel Aviv, , Israel
Chungbuk National University Hospital,Substudy-01
Cheongju-si, , South Korea
Chungbuk National University Hospital,Substudy-02
Cheongju-si, , South Korea
National Cancer Center,Substudy-01
Goyang, , South Korea
National Cancer Center,Substudy-02
Goyang, , South Korea
National Cancer Center,Substudy-03
Goyang, , South Korea
Chonnam National University Hwasun Hospital,Substudy-01
Gwangju, , South Korea
Chonnam National University Hwasun Hospital,Substudy-03
Gwangju, , South Korea
Seoul National University Bundang Hospital,Substudy-01
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital,Substudy-03
Gyeonggi-do, , South Korea
Kosin University Gospel Hospital,Substudy-01
Seogu, , South Korea
Kosin University Gospel Hospital,Substudy-03
Seogu, , South Korea
Severance Hospital, Yonsei University Health System,Substudy-03
Seoul, , South Korea
Asan Medical Center,Substudy-02
Seoul, , South Korea
Asan Medical Center,Substudy-03
Seoul, , South Korea
Asan Medical Centre,Substudy-01
Seoul, , South Korea
Samsung Medical Center,Substudy-01
Seoul, , South Korea
Samsung Medical Center,Substudy-02
Seoul, , South Korea
Samsung Medical Center,Substudy-03
Seoul, , South Korea
Severance Hospital, Yonsei University Health System,Substudy-01
Seoul, , South Korea
Severance Hospital, Yonsei University Health System,Substudy-02
Seoul, , South Korea
Seoul National University,Substudy-01
Seoul, , South Korea
Seoul National University,Substudy-02
Seoul, , South Korea
Korea University Guro Hospital,Substudy-01
Seoul, , South Korea
Korea University Guro Hospital,Substudy-03
Seoul, , South Korea
Changhua Christian Hospital,Substudy-01
Changhua, , Taiwan
Changhua Christian Hospital,Substudy-02
Changhua, , Taiwan
Changhua Christian Hospital,Substudy-03
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
Kaohsiung City, , Taiwan
National Taiwan University Hospital,Substudy-01
Taipei, , Taiwan
National Taiwan University Hospital,Substudy-02
Taipei, , Taiwan
Memorial Ankara Hastanesi,Substudy-01
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital,Substudy-03
Ankara, , Turkey (Türkiye)
Dicle University,Substudy-01
Diyarbakır, , Turkey (Türkiye)
Dicle University Medical Faculty,Substudy-03
Diyarbakır, , Turkey (Türkiye)
Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01
Konya, , Turkey (Türkiye)
Necmettin Erbakan Universitesi,Substudy-03
Meram Konya, , Turkey (Türkiye)
Gazi University Medical Faculty,Substudy-03
Yenimahalle, , Turkey (Türkiye)
Birmingham Heartlands Hospital,Substudy-03
Birmingham, , United Kingdom
University Hospitals Birmingham NHS Trust,Substudy-01
Birmingham, , United Kingdom
University Hospitals Birmingham NHS Trust,Substudy-02
Birmingham, , United Kingdom
St James University Hospital,,Substudy-01
Leeds, , United Kingdom
St. Bartholomew's Hospital,Substudy-01
London, , United Kingdom
St. Bartholomew's Hospital,Substudy-02
London, , United Kingdom
St. Bartholomew's Hospital,Substudy-03
London, , United Kingdom
Countries
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Central Contacts
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Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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MOH_2022-12-13_012231
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-624-6376
Identifier Type: -
Identifier Source: org_study_id