At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 and ≤75 years
- ✓Histologically/cytologically confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC
- ✓Cohort A: No EGFR/ALK/ROS1 mutations, relapsed after first-line anti-PD-1/PD-L1 antibody with prior response ≥6 months
- ✓Cohort B: EGFR-sensitive mutations or ALK fusion, relapsed after anti-EGFR-TKI or ALK-TKI therapy
- ✕Small cell lung cancer (SCLC) or mixed SCLC/NSCLC
- ✕Imaging evidence of tumor necrosis, cavitation or large vessel invasion/proximity
- ✕Cohort A: Prior immunotherapy toxicity requiring permanent discontinuation or unrecovered to grade ≤1
- ✕Cohort B/C: Prior anti-PD-1/PD-L1/PD-L2 or other T-cell checkpoint inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04777084Phase 2RecruitingUpdate OverdueUpdated 15mo ago · Completion was 18mo agoA Prospective, Multi-cohort Clinical Research of Efficacy and Safety of Bispecific Anti-PD-1 / PD-L1 Antibody IBI318 Combined with Lenvatinib in the Treatment of Advanced NSCLC
In Brief
A Phase 2 clinical trial evaluating IBI318 for Non-Small Cell Lung Cancer. Currently recruiting, targeting 120 participants across 1 site.
Signals
Detailed Summary
The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type. After being screened to meet the inclusion criteria, they will receive IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.
Study Details
Timeline
Interventions
IBI318, 300 mg, administered by intravenous infusion on the first day of each cycle, 1 cycle every 2 weeks (Q2W), continuous medication; lenvatinib 8 mg, orally, continued medication until disease progression, death, toxicity is intolerable, Withdrawal of informed consent, start a new anti-tumor treatment or terminate the treatment for other reasons specified in the plan, the maximum use time is 2 years.