RecruitingPhase 2NCT05118854

A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation


Sponsor

M.D. Anderson Cancer Center

Enrollment

27 participants

Start Date

Mar 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II, single-arm, open-label study evaluating the efficacy, safety and tolerability of neoadjuvant sotorasib in combination with cisplatin (or carboplatin) and pemetrexed chemotherapy for patients with surgically resectable stage IIA - IIIB (T3-T4/N2) (based on AJCC 8th edition), non-squamous NSCLC with a KRAS p.G12C mutation. The primary objective of the study is to determine whether neoadjuvant therapy with 4 cycles of at least one dose of sotorasib plus cisplatin (or carboplatin) and pemetrexed can be administered safely and result in improved MPR rate in patients with KRAS p.G12C-mutant non-squamous NSCLC compared with the historical control MPR rate for platinum-based chemotherapy alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a targeted drug called sotorasib — given before surgery — in combination with standard chemotherapy drugs (cisplatin or carboplatin plus pemetrexed) for people with early-stage non-small cell lung cancer that has a specific mutation called KRAS G12C. Sotorasib works by directly blocking the KRAS G12C protein that drives cancer growth. Giving it before surgery (neoadjuvant therapy) may shrink the tumor and improve surgical outcomes. **You may be eligible if...** - You are over 18 with confirmed non-squamous non-small cell lung cancer (e.g., adenocarcinoma) - Your tumor has a KRAS G12C mutation confirmed by testing - Your cancer is stage IIA to IIIB and considered surgically removable - You have not had prior treatment for this lung cancer - You are in adequate health to tolerate surgery and chemotherapy **You may NOT be eligible if...** - Your tumor is pure squamous cell carcinoma, neuroendocrine carcinoma, small-cell type, or sarcomatoid carcinoma - You have had previous systemic treatment for this cancer - You have uncontrolled infection, severe organ dysfunction, or cannot take the oral medication - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAMG 510

Given by IV

DRUGCisplatin

Given by IV

DRUGCarboplatin

Given by IV

DRUGPemetrexed

Given by IV


Locations(2)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05118854


Related Trials