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

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT07472478
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • KRAS G12C Lung Cancer
  • Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Garsorasib — DRUG
    Garsorasib 600 mg, twice daily, for 4 to 6 weeks
  • Ivonescimab Combined With Chemotherapy — DRUG
    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.
  • Surgery — PROCEDURE
    Surgery
  • Garsorasib — DRUG
    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.
  • Ivonescimab — DRUG
    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.
  • Observation — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant therapy phase
    sequential preoperative regimen beginning with a 4- to 6-week lead-in phase of targeted monotherapy using Garsorasib (600 mg twice daily), followed by three cycles of combination chemoimmunotherapy comprising Ivonescimab (20 mg/kg), pemetrexed, and carboplatin, ultimately culminating in definitive surgical resection.

Primary Outcome Measure

Pathologic complete response (pCR) rate assessed according to the IASLC recommendations for pathologic evaluation of lung cancer neoadjuvant therapy [ Time Frame: 14-24 weeks ]

Central Contacts

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