OncoMatch/Clinical Trials/NCT05671510
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Is NCT05671510 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Gotistobart and Docetaxel for non small cell lung cancer.
Treatment: Gotistobart · Docetaxel — The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: EGFR actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: ALK actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: ROS1 actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: HER2 (ERBB2) actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: MET actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: BRAF actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: RET actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: NTRK1 actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: NTRK2 actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Required: NTRK3 actionable mutation or genomic alteration
Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK; Exception: KRAS mutations are not excluded.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy — most recent line
At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy
Must have received: platinum-based chemotherapy followed by PD-1 or PD-L1 inhibitor-based immunotherapy — most recent line
Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Impaired heart function excluded
Adequate organ functions. Serum LDH level ≤ 2xULN. Impaired heart function [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- XCancer/Dothan Hematology & Oncology - 1114 · Dothan, Alabama
- Genesis Cancer and Blood Institute - 1123 · Russellville, Arkansas
- The Oncology Institute (TOI) Clinical Research - 1109 · Cerritos, California
- Emad Ibrahim MD Inc. - 1147 · Redlands, California
- UC Davis Comprehensive Cancer Center - 1103 · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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