About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is > 12 months.
2. Presence of a KRAS G12C mutation (all participants) and:
3. Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status
4. Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation
5. At least one measurable lesion per RECIST 1.1.
6. ECOG performance status ≤ 1.
7. Participants capable of swallowing study medication. Key

Exclusion criteria

1. Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
2. Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
3. A medical condition that results in increased photosensitivity (i.e. solar urticaria, lupus erythematosus, etc).
4. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
5. Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study Other inclusion/

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.