NCT07492342

Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC

Evaluation of Efficacy and Safety of Fulzerasib Sequentially Combined With Sintilimab Plus Platinum-Doublet Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer With KRAS G12 Mutation: a Single-Arm, Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jianxing He · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation. Approximately 30 treatment-naïve patients with stage IB-IIIA (AJCC 8th edition) NSCLC and confirmed KRAS G12C mutation will be enrolled. Eligible subjects will receive 6 weeks of fulzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy. An end-of-treatment visit will be performed within 7 days after the last dose of neoadjuvant therapy.

Detailed description

Following neoadjuvant therapy, subjects without disease progression (per RECIST 1.1) and meeting criteria for radical resection will undergo curative surgery within 7-28 days after the last dose of neoadjuvant therapy. Subjects with disease progression (per RECIST 1.1) or who do not meet criteria for radical resection will discontinue study treatment. Subjects assessed with disease progression during neoadjuvant therapy will also discontinue study treatment, with subsequent therapy at the investigator's discretion; subjects without disease progression will continue to complete remaining neoadjuvant therapy. Adjuvant and other postoperative therapy will be determined by the investigator. Pathologic complete response (pCR) and major pathologic response (MPR) rates will be evaluated by the investigator in resected pathological specimens according to the International Expert Consensus on Neoadjuvant Immunotherapy for NSCLC. Clinical tumor imaging assessments will be performed by the investigator per RECIST 1.1. Preoperative imaging will include at least neck, chest, abdomen, and pelvis (after 6 weeks of neoadjuvant targeted therapy and before sequential chemo-immunotherapy, and 7-28 days after the last neoadjuvant treatment and prior to surgery). Tumor assessment will be performed 14-28 days after surgery as the postoperative baseline, to be completed before the first adjuvant therapy. Imaging assessments will then be conducted every 12 weeks (±7 days) post-baseline for up to 2 years, or until disease progression, withdrawal, loss to follow-up, death, or other protocol-specified criteria, whichever occurs first.

Conditions

• Resectable NSCLC
• KRAS G12C Mutation
• Stage IB-IIIA NSCLC
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	fulzerasib	Eligible subjects will receive 6 weeks of furzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy.

Timeline

• Start date: 2026-01-29
• Primary completion: 2027-03-31
• Completion: 2027-12-31
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

3 sites across 1 country: China