Actively Recruiting
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-02-13
54
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the major pathologic response (MPR) rate of a neoadjuvant treatment combining sintilimab (a PD-1 inhibitor), IBI310 (an anti-CTLA-4 antibody), and chemotherapy in patients with PD-L1-negative stage II to IIIB non-small cell lung cancer (NSCLC) who are scheduled for surgery. The study focuses on patients without distant metastasis or unresectable tumor extension, assessing the effectiveness of this treatment strategy before surgery. Participants will receive a neoadjuvant therapy consisting of four planned doses of sintilimab (200 mg intravenous infusion every 3 weeks) at weeks -12, -9, -6, and -3, and one dose of IBI310 (1 mg/kg intravenous infusion) at week -12. Chemotherapy is also given at the same weeks, with regimens differing based on cancer type: non-squamous NSCLC patients receive pemetrexed plus carboplatin, while squamous NSCLC patients receive nanoparticle albumin-bound paclitaxel plus carboplatin. Surgery will occur at least 3 weeks after the last dose if the patient is deemed operable. After surgery, patients may continue standard adjuvant therapy with PD-1 inhibitors for up to one year. During the study, participants will be monitored for responses to treatment, including the major pathologic response rate approximately 5 months after enrollment. Safety and tolerability will be assessed by tracking treatment-emergent adverse events from consent through 30 days after the last drug administration. Additional outcomes include pathological complete response, overall response rate at 12 weeks, event-free survival, and overall survival for up to 5 years. The total study duration includes the neoadjuvant phase, surgery, possible adjuvant therapy, and long-term follow-up.
CONDITIONS
Brief Title
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age 18 years or older.
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).
- No prior anticancer therapy, including chemotherapy, immunotherapy, or radiotherapy; traditional Chinese medicine for anticancer intent must be stopped 2 weeks before first dose.
- Investigator-assessed resectable Stage II-IIIB NSCLC (excluding N3) according to AJCC 9th edition.
- Non-squamous NSCLC patients must have no EGFR mutation, ALK rearrangement, or other targetable driver mutations; squamous NSCLC patients must have no known EGFR mutation, ALK rearrangement, or actionable driver mutation.
- Negative PD-L1 expression by 22C3 or E1L3N assays.
- ECOG performance status 0 or 1.
- Adequate organ function within 7 days before first dose, including blood counts, kidney and liver function, coagulation, and lung function suitable for surgery.
- Fertile females must have a negative pregnancy test within 7 days before first dose.
- Fertile females and males with partners of childbearing potential must use highly effective contraception from 7 days before first dose until 24 weeks after last dose.
You will not qualify if you...
- Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery.
- Use of systemic corticosteroids over 10 mg/day for 7 or more consecutive days within 14 days before first dose, except for inhaled, topical, or physiological replacement doses; short courses under 7 days allowed.
- Receipt of live vaccines within 28 days before first dose.
- Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids.
- Active autoimmune disease or history of autoimmune disease, except type 1 diabetes, stable hypothyroidism under hormone therapy, psoriasis, or vitiligo not needing systemic treatment.
- Other malignancies within 5 years before first dose, except tumors deemed cured.
- Uncontrolled comorbidities including active hepatitis B or C, HIV/AIDS, active tuberculosis, prolonged infections requiring systemic antibiotics, significant cardiovascular disease, or abnormal urine protein tests.
- History of allogeneic stem-cell or solid-organ transplantation.
- Severe hypersensitivity to antibody therapies, history of anaphylaxis, uncontrolled asthma, or significant drug allergies.
- Pregnancy or lactation.
- Other conditions affecting safety or compliance, such as psychiatric disorders or uncontrolled serosal cavity effusions requiring repeated drainage.
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 9 weeks
Participants receive neoadjuvant therapy consisting of four planned doses of sintilimab combined with chemotherapy and one dose of IBI310 before surgery.
4 visits (intravenous infusions) every 3 weeks
Duration - 1 day
Participants undergo surgery at least 3 weeks after the last dose of neoadjuvant therapy if deemed operable by the investigator.
1 visit (in-person surgery)
Duration - Up to 1 year
Participants may continue standard adjuvant therapy with PD-1 inhibitor for up to one year after surgery.
Visits as per standard adjuvant therapy schedule
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Chang Chen, 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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