Clinical Trials in South Korea / NCT05633667
Active, not recruiting
Phase 2
Study of Novel Treatment Combinations in Patients With Lung Cancer
NCT05633667 · tracked via the Priya Life Science South Korea tracker
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)Carboplatin →Cisplatin →Pemetrexed →Paclitaxel →Nab-paclitaxel →Docetaxel →Nivolumab →
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
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 | Status |
|---|---|---|---|
| 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.
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05633667 on ClinicalTrials.gov ↗ ← All trials in South Korea