Study of Novel Treatment Combinations in Patients With Lung Cancer (NCT05633667) — USA Trial Details

Condition(s) studied

Lung CancerAdvanced or Metastatic Non-Small-Cell Lung CancerResectable Non-Small-Cell Lung Cancer

Investigational drug(s) / intervention(s)

Zimberelimab (ZIM)Domvanalimab (DOM)Sacituzumab govitecan-hziy (SG)Etrumadenant (ETRUMA)CarboplatinCisplatinPemetrexedPaclitaxelNab-paclitaxelDocetaxelNivolumab

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

Study summary

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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

Primary outcome measure(s)

Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — Up to 5 years
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.
Substudy 03: Complete Pathological Response (pCR) Rate — Up to 5 years
pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.

Trial sites (89)

Facility	City	Region
Arizona Oncology Associates,Substudy-02	Tucson	Arizona
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03	Fort Wayne	Indiana
Baptist Health Lexington,Substudy-03	Lexington	Kentucky
Washington University School of Medicine - Siteman Cancer Center,Substudy-01	St Louis	Missouri
Washington University School of Medicine - Siteman Cancer Center,Substudy-02	St Louis	Missouri
Washington University School of Medicine - Siteman Cancer Center,Substudy-03	St Louis	Missouri
Washington University School of Medicine - Siteman Cancer Center	St Louis	Missouri
Oncology Hematology Care Clinical Trials, LLC,Substudy-01	Cincinnati	Ohio
Oncology Hematology Care Clinical Trials, LLC,Substudy-02	Cincinnati	Ohio
Oncology Associates of Oregon, PC,Substudy-01	Eugene	Oregon
Oncology Associates of Oregon, PC,Substudy-02	Eugene	Oregon
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 - Hospital do Câncer AC Camargo,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
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

+ 49 more sites — see the full list on the official registry below.

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