Phase 3 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with non-small cell lung cancer (NSCLC) that is at an advanced stage (Stage IIIB, IIIC, or Stage IV) and is not suitable for surgery or radiation therapy aimed at curing the disease.
• For certain parts of the trial (Part B and Safety Lead-In Part B): People whose lung cancer is mainly a type called "non-squamous" (a specific cancer cell type — confirm with trial site if unsure which type applies).
• People whose cancer has a specific gene change called a KRAS G12C mutation.
• People whose cancer has been tested for a protein called PD-L1, with different levels required depending on which part of the trial is involved (Part A: 50% or higher; Part B: any level from 0–100%; Part C: less than 50%).
• People whose cancer can be measured using standard imaging guidelines (called RECIST v1.1).
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (ECOG score of 0 or 1).
• People with an estimated life expectancy of at least 12 weeks.
• People who are able to swallow capsules.
• People whose blood test results meet the required health levels set by the trial.
• People who are able to follow the contraception requirements set by local regulations for clinical trial participants.
• Women who could become pregnant must have a negative pregnancy test before joining and must not be breastfeeding during treatment.

Who may not be able to join:

• People whose cancer has other specific gene changes or mutations — such as in EGFR, ALK, BRAF (V600E), HER2, MET (exon 14), ROS1, RET, or NTRK1/2/3 — that could be targeted by other treatments.
• People who have already received systemic treatments for advanced or metastatic NSCLC, such as chemotherapy, immunotherapy, targeted therapy, or biological therapy — although one cycle of standard treatment may be allowed in cases where immediate treatment was medically necessary before enrolling (confirm with trial site).
• People who have active cancer that has spread to the brain or the membranes surrounding the brain or spinal cord.
• For Part B and Safety Lead-In Part B only: People whose NSCLC is mainly the squamous cell type.
• For Part B and Safety Lead-In Part B only: People with mild to moderate kidney problems who are unable to stop taking aspirin, ibuprofen, or similar anti-inflammatory pain medicines around the time of a specific treatment called pemetrexed.
• For Part B and Safety Lead-In Part B only: People who are unable or unwilling to take folic acid or vitamin B12 supplements as required.

Important: Always verify eligibility with the trial site directly before applying.