RecruitingPhase 2NCT07410975

Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer

Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer: A Phase II, Single-Arm Clinical Study


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

54 participants

Start Date

Jan 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding two immunotherapy drugs (anti-CTLA-4 antibody and sintilimab, a PD-1 inhibitor) together with standard chemotherapy before surgery improves outcomes for patients with surgically removable Stage II or III non-small cell lung cancer (NSCLC) that does not respond to PD-L1 immunotherapy alone. **You may be eligible if...** - You are 18 or older with confirmed NSCLC that can be surgically removed (Stage II to IIIB, excluding N3) - Your tumor is PD-L1 negative - You have not received any prior cancer treatment (chemotherapy, immunotherapy, or radiation) - Your tumor does not have targetable mutations like EGFR or ALK - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have active autoimmune disease or are on immune-suppressing medications - You have a history of serious lung inflammation (interstitial pneumonia) - You have had recent major surgery or another active cancer within the past 5 years - You have uncontrolled cardiovascular disease (recent heart attack, stroke, or severe heart failure) - You are pregnant or breastfeeding - You have active hepatitis B or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsintilimab+IBI310+chemotherapy

1. Neoadjuvant therapy phase: four planned doses of sintilimab 200 mg intravenous infusion at weeks -12, -9, -6, and -3 (Q3W); one planned dose of IBI310 1 mg/kg intravenous infusion at week -12; four planned doses of chemotherapy at weeks -12, -9, -6, and -3 (Q3W). Non-squamous NSCLC: pemetrexed 500 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. Squamous NSCLC: nanoparticle albumin-bound paclitaxel 260 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. 2. Surgery phase: At least 3 weeks after the last dose of the study drug , participants deemed operable by the investigator will undergo surgery.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

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NCT07410975


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