drugset
drugset / Trial / NCT07492342

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

NCT07492342 ↗

Phase 2 Recruiting 30 enrolled Jianxing He Innovent Biologics (Suzhou) Co. Ltd. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-29
Primary completion
2027-03-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulzerasib Small molecule 600 mg Oral
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 260 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

acute myeloid leukemia, KRAS gene mutation non-small cell lung carcinoma