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Study identifier: NCT04777084 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-Small Cell Lung Cancer  ·  Sponsor: Hunan Province Tumor Hospital

PhasePhase 2
Planned participants120
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.

This description comes directly from the study's public registry record.

Talk to the study team

Yongchang Yongchang, MD  ·  +8613873123436  ·  zhangyongchang@csu.edu.cn

Nong Yang, MD  ·  +8613055193557  ·  yangnong0217@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Hunan Cancer hospitalChangsha, Hunan, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT04777084