Phase II Study of Sotorasib with Chemotherapy Before Surgery for Treatable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer with KRAS p.G12C Mutation

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05118854

Provider View

This clinical trial is testing a new treatment approach using sotorasib combined with chemotherapy drugs cisplatin or carboplatin and pemetrexed before surgery in patients with a specific type of lung cancer that can be surgically removed. The study aims to see if this combination is safe and more effective than chemotherapy alone.

Patient Parameters

Program Overview

This study is exploring whether a combination of sotorasib and chemotherapy drugs (cisplatin or carboplatin and pemetrexed) given before surgery can improve outcomes for patients with a specific type of lung cancer that has a KRAS p.G12C mutation. The main goal is to determine if this treatment can be safely administered and if it leads to better tumor response compared to traditional chemotherapy alone.

Description

The study focuses on patients with a specific type of lung cancer that can be surgically removed and has a KRAS p.G12C mutation. The treatment involves giving sotorasib along with chemotherapy drugs cisplatin or carboplatin and pemetrexed before surgery. Researchers aim to see if this combination can improve the rate of major pathologic response, which means a significant reduction in cancer cells in the tumor after treatment.

The study will also assess the safety and tolerability of this treatment combination. Secondary goals include evaluating how well the treatment works in terms of overall response rate, survival without cancer recurrence, and overall survival. Researchers will also explore how the treatment affects certain biological markers and the immune system's response to the cancer.

Participants will receive four cycles of the treatment before surgery. The study will monitor the effects of the treatment on the tumor and any side effects experienced by the participants. The results will help determine if this approach could be a better option for patients with this type of lung cancer.

Eligibility Criteria

Exclusion Criteria

  • Have received any previous cancer treatment for the current lung cancer.
  • Have a type of lung cancer that is not eligible for surgery.
  • Have a history of certain other cancers unless they have been treated and are not active for at least 2 years.
  • Have significant heart disease or recent heart attack.
  • Have gastrointestinal issues that prevent taking oral medication.
  • Have active infections requiring treatment within 2 weeks before starting the study.
  • Have a history of lung disease or drug-induced lung problems.
  • Have serious medical conditions that could increase risks or interfere with the study.
  • Have moderate or severe hearing loss.
  • Have significant nerve damage.
  • Are unable or unwilling to follow study procedures.
  • Have a positive test for hepatitis B or C, or HIV.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a history of substance abuse within the past year.
  • Are unwilling to take necessary medications or supplements required by the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are unwilling to use effective contraception during and after the study treatment.

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