Actively Recruiting
A Multicenter Phase II Trial of Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III Non-Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2026-04-21
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with unresectable stage III non-small cell lung cancer (NSCLC) that combines neoadjuvant IBI308, bevacizumab, pemetrexed, and carboplatin followed by surgery. This approach is being studied because current combined chemoradiotherapy offers limited prognosis, and surgery may provide a chance for cure. IBI308 is a humanized anti-PD-1 monoclonal antibody being assessed for its role in this treatment. The study involves giving participants four cycles of neoadjuvant therapy every 21 days. During each cycle, IBI308 is given as a 200 mg intravenous infusion, bevacizumab is administered at 15 mg/kg, pemetrexed is injected intravenously at 500 mg/m², and carboplatin is dosed intravenously based on serum concentration. Surgery is scheduled at least 21 days after completing the neoadjuvant therapy. Participants will be closely monitored through the neoadjuvant treatment and surgery phases. Researchers will assess the resectability rate within three months and track perioperative complications for two years. The study includes blood tests and performance status evaluations to ensure safety and adherence. Overall participation involves treatment cycles, surgery, and follow-up assessments extending over multiple years.
CONDITIONS
Brief Title
Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unresectable stage III non-small cell lung cancer.
- Provided written informed consent.
- No previously detected sensitizing EGFR mutation or ALK fusion oncogene.
- Male or female aged 18 to less than 75 years.
- Able to follow the study protocol, attend follow-ups, and take oral medications.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate blood counts: ANC ≥ 2.0 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hemoglobin ≥ 9 g/dL (may be transfused).
- Adequate liver function: Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN without liver metastases or ≤ 5 x ULN with liver metastases.
- Adequate kidney function: Serum creatinine ≤ 1.25 x ULN or creatinine clearance ≥ 60 ml/min.
- Female participants must not be pregnant or breastfeeding.
You will not qualify if you...
- Known severe allergy to IBI308 or its components.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or similar immune therapies.
- Previous chemotherapy or radiotherapy.
- Active or suspected autoimmune disease requiring systemic treatment.
- Use of systemic corticosteroids above 10 mg prednisone equivalent daily within 14 days before treatment.
- Inability to comply with study procedures.
- Serious systemic illness that may prevent study completion.
- Recent serious heart conditions such as heart attack within 6 months or unstable angina.
- History of other cancers in the last 5 years except certain cured skin or cervical cancers.
- Unstable systemic diseases including infections, uncontrolled blood pressure, heart failure, arrhythmias, liver, kidney, or metabolic diseases.
- Active serious infection with fever over 38.0°C.
- Known HIV or AIDS.
- Active Hepatitis B or C infection.
- Pregnant or nursing women.
- Any other disease or condition that increases risk with investigational treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive neoadjuvant therapy with IBI308, bevacizumab, pemetrexed, and carboplatin in four 21-day cycles.
4 visits (in-person), one at the start of each 21-day cycle
Duration - Surgery day plus immediate recovery
Participants undergo thoracic surgery at least 21 days after completing neoadjuvant therapy.
1 visit (in-person) for surgery
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
S
Si-Yu Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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