JDQ443 for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+74 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study aims to assess the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \< 1% regardless of STK11 mutation status (cohort A), or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation (KRAS G12C). Participants must have a PD-L1 expression level below 1% or above 1% with an STK11 co-mutation, and should not have had previous systemic treatment for metastatic NSCLC. They need to be able to swallow pills, have at least one measurable tumor lesion, and be in good physical condition.

Inclusion Criteria

I had chemotherapy, immunotherapy, or radiotherapy over a year ago for early-stage cancer.

My cancer has PD-L1 expression of 1% or more and an STK11 mutation.

My cancer has PD-L1 expression under 1%, STK11 mutation status doesn't matter.

+5 more

Exclusion Criteria

My cancer has EGFR mutation or ALK rearrangement.

I have a condition that makes my skin extra sensitive to sunlight.

I am not taking any strong medications that can't be stopped a week before starting the study treatment.

+3 more

Participant Groups

The study tests JDQ443 as the first-line treatment for NSCLC patients with KRAS G12C mutations. It's divided into two groups based on their PD-L1 expression levels: one group has less than 1%, while the other has more than 1% plus an STK11 mutation. The drug's effectiveness and safety are being evaluated.

2Treatment groups

Experimental Treatment

Group I: Cohort B- PD-L1≥ 1% and STK11 mutationExperimental Treatment1 Intervention

Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.

Group II: Cohort A- PD-L1<1%Experimental Treatment1 Intervention

Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \<1%, regardless of STK11 mutation status.