Actively Recruiting
The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.
Led by Hunan Province Tumor Hospital · Updated on 2025-03-05
120
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.
CONDITIONS
Official Title
The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Age between 18 and 75 years old
- Any gender
- Cohort A: Advanced NSCLC without EGFR, ALK, or ROS1 mutations, progressed after first-line PD-1/PD-L1 therapy
- Cohort B: Advanced NSCLC with EGFR-sensitive mutations or ALK fusion, progressed after EGFR-TKI or ALK-TKI treatment
- Cohort C: Advanced NSCLC with negative PD-L1 expression and wild-type EGFR, ALK, and ROS1, no prior immunotherapy
- At least one measurable lesion by RECIST v1.1 criteria
- Stable or asymptomatic brain metastases allowed under specified conditions
- ECOG performance status 0-1
- Expected survival over 3 months
- Adequate organ function as defined by laboratory criteria
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during treatment and for a period afterward
- Controlled blood pressure (≤150/90 mmHg)
You will not qualify if you...
- Small cell lung cancer or mixed SCLC/NSCLC pathology
- Tumor invasion or proximity to large blood vessels with bleeding risk
- For Cohort A: prior immunotherapy toxicities that caused discontinuation or unresolved toxicities
- For Cohorts B and C: prior treatment with PD-1, PD-L1, or PD-L2 inhibitors or similar agents
- Recent systemic anti-tumor therapy within 2 weeks
- Prior use of lenvatinib, bevacizumab, or anlotinib
- Use of investigational drugs within 4 weeks
- Recent use of high-dose immunosuppressants within 4 weeks
- Recent live attenuated vaccine within 4 weeks
- Major surgery or unhealed wounds within 4 weeks
- Significant cardiovascular events within 12 months
- Gastrointestinal conditions affecting drug absorption or fistulas
- History of other malignancies without 3 years disease-free
- Severe allergy to study drugs
- Uncontrolled effusions
- Recent thoracic radiotherapy over 30 Gy within 6 months
- Active autoimmune disease requiring systemic treatment within 2 years
- Organ transplantation history except corneal
- Positive HIV infection
- Untreated active hepatitis B or C except under specified control
- Pregnancy or lactation
- Serious or uncontrollable systemic diseases including severe heart conditions, active infections, liver disease, uncontrolled diabetes, proteinuria, mental disorders preventing cooperation
- Any other conditions interfering with study participation or safety as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
Yongchang Yongchang, MD
CONTACT
N
Nong Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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