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.
Eligible patients were investigator - determined surgical candidates with resectable stage II-IIIB NSCLC, negative PD-L1 expression, no evidence of distant metastasis , and no evidence of unresectable localized tumor extension. This study plans to enroll 54 patients.Patients are scheduled to receive one preoperative dose of sintilimab plus IBI310 combined with chemotherapy and three doses of sintilimab combined with chemotherapy as neoadjuvant therapy. Surgery will be performed on patients deemed operable by the investigator at least 3 weeks after the last dose of study drug. Following surgery, the investigator will assess the patient's response. Postoperatively, patients may continue receiving standard adjuvant therapy with PD-1 inhibitor for one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGMPR Rate
Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.
Time frame: about 5 months after enrollment
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence and severity of adverse events (according to CTCAE v6.0 criteria), severity and its relationship to the experimental treatment; any abnormal laboratory test results, vital signs and physical examination results, etc.
Time frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug
pCR Rate
Defined as the proportion of all patients who completed treatment and had no invasive viable tumor in both the primary tumor and the sampled lymph nodes after surgery.
Time frame: about 5 months after enrollment
Overall Response Rate (ORR)
The proportion of patients who have had a complete response (CR) or partial response (PR) (according to RECIST1.1) after the neoadjuvant therapy.
Time frame: 12 weeks
Event Free Survival (EFS)
The time from enrollment to first occurrence of progression, disease recurrence (including local and distant recurrence), or death from any cause is assessed according to RECIST v1.1.
Time frame: up to 5 years
Overall Survival (OS)
Defined as the time from enrollment to the participant's death from any cause.
Time frame: up to 5 years
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