A Phase 2 Study of Sotorasib Plus Pemetrexed and Cisplatin or Carboplatin for People With Non-Squamous Non-Small Cell Lung Cancer

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Full Title

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

Purpose

Sotorasib is used to treat non-small cell lung cancer (NSCLC) caused by a mutation (change) in the KRAS G12C gene. It is used for people with NSCLC that has spread or is inoperable (cannot be removed with surgery). In this study, researchers are assessing sotorasib with standard chemotherapy before surgery. They want to see if this drug combination increases the percentage of cancer cells killed before surgery, called “pathologic response.”

The people in this study have NSCLC that has not yet been treated and is operable (can be taken out). In addition, their cancer has a KRAS G12C gene mutation. This mutation can cause cancer cells to grow.

If you join this study, you will take sotorasib orally (by mouth) before surgery. You will also get pemetrexed and either carboplatin or cisplatin before surgery. Those anti-cancer drugs are given intravenously (by vein). Doctors routinely give these drugs to people with NSCLC who are scheduled to have surgery to take out the cancer.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have NSCLC that will be taken out with surgery and has a KRAS G12C mutation.
  • Not have squamous cell lung cancer.
  • Not have had prior treatment for NSCLC.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Jamie Chaft’s office at 646-608-3761.

Protocol

23-314

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05118854