NCT07472478

Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)

An Exploratory Phase II Clinical Study Protocol of Perioperative Treatment With Glesorasib Sequentially Combined With Ivonescimab and Chemotherapy for Resectable, Stage IB-IIIB, KRAS G12C-Mutant NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, open-label clinical trial. It enrolls previously untreated patients with resectable stage IB-IIIB KRAS G12C mutation-positive NSCLC to evaluate the efficacy and safety of glesorasib sequentially combined with ivonescimab and chemotherapy as perioperative treatment for this patient population.

Conditions

• Lung Cancer (NSCLC)
• KRAS G12C Lung Cancer

Interventions

Type	Name	Description
DRUG	Garsorasib	Garsorasib 600 mg, twice daily, for 4 to 6 weeks
DRUG	Ivonescimab Combined With Chemotherapy	After a 2-week washout period, administer Ivonescimab 20 mg/kg in combination with the PC regimen (paclitaxel 135-175 mg/m² + carboplatin AUC 5) every 3 weeks.
PROCEDURE	Surgery	Surgery
DRUG	Garsorasib	If MRD is positive and KRAS is positive, adjuvant therapy with Garsorasib 600 mg twice daily should be administered until disease progression, unacceptable toxicity, withdrawal of informed consent, death, or termination due to other reasons, whichever occurs first.
DRUG	Ivonescimab	If MRD is positive and KRAS is negative, adjuvant therapy with Ivonescimab 20 mg/kg every 3 weeks should be administered until disease progression, unacceptable toxicity, withdrawal of informed consent, death, or termination due to other reasons, whichever occurs first.
BEHAVIORAL	Observation	If MRD is negative, the patient should be placed under observation; once it turns positive, they will enter the corresponding treatment group as described above.

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2026-03-16
• Last updated: 2026-03-16