NCT04777084

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.

A 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.

Detailed description

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IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan. During the treatment, RECIST v1.1 was used for clinical tumor imaging evaluation, once every 6 weeks; after 24 weeks of medication, evaluation can be done every 8 weeks. Subjects receiving IBI318 combined with lenvatinib have the first evidence of imaging PD according to RECIST v1.1. If the subject is clinically stable, there is no evidence of rapid imaging progress, and the investigator assesses that it can continue from the study If the patient is benefited from the drug, the subject can continue the current study treatment, and the imaging evaluation must be repeated at least 6 weeks (± 7 days) later for confirmation. If PD is confirmed by re-assessment, the subject should stop the study treatment; if PD is not confirmed, the study treatment will continue, and the assessment will be carried out at the time point of the imaging examination plan specified in the plan until the PD is confirmed by imaging.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	IBI318	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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-12-30
• Completion: 2025-12-25
• First posted: 2021-03-02
• Last updated: 2025-03-05

Locations

1 site across 1 country: China