NCT07472478PHASE2NOT_YET_RECRUITING

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

Sponsor: Guangdong Provincial People's Hospital

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Lung Cancer (NSCLC), KRAS G12C Lung Cancer

Interventions

Garsorasib, Ivonescimab Combined With Chemotherapy, Surgery, Garsorasib

Enrollment

32 participants

Primary completion

Dec 2027

Study completion

Mar 2028

First posted

Mar 2026

Last updated

Mar 2026

Primary Endpoints (CT.gov)

Pathologic complete response (pCR) rate assessed according to the IASLC recommendations for pathologic evaluation of lung cancer neoadjuvant therapy

Time frame: 14-24 weeks

Secondary Endpoints

Major Pathological Response (MPR) rate assessed according to the IASLC recommendations for pathologic evaluation of lung cancer neoadjuvant therapy

R0 resection rate

Objective Response Rate (ORR)

Eligibility Criteria

Inclusion Criteria: 1. Age Range: Males or females aged 18 years or older. 2. Diagnosis and Stage: Patients with histologically or cytologically confirmed resectable IB-IIIB NSCLC, staged according to the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, 9th Edition. 3. Informed Consent: Patients must voluntarily participate in the study, provide written informed consent, and be willing to comply with follow-up procedures. 4. Prior Therapy: No prior systemic therapy for locally advanced or metastatic NSCLC (including adjuvant chemo/radiotherapy, neoadjuvant chemo/radiotherapy, definitive chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, or anti-angiogenic therapy for locally advanced disease). 5. Mutation Status: KRAS G12C mutation positivity must be confirmed by next-generation sequencing (NGS) or polymerase chain reaction (PCR) testing. 6. Measurable Disease: At least one measurable target lesion …

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov