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

NCT07472478 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2027-12-31
Completion
2028-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07472478 on ClinicalTrials.gov