About the study

This is a phase III open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.

Who can take part?

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

Inclusion criteria

1. Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
2. Participant has a KRAS G12C mutation present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
3. Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
4. Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.

Exclusion criteria

1. Participant has previously received docetaxel, KRAS G12C inhibitor or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune check point inhibitor
2. Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
3. Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
4. Participant has an history of interstitial lung disease or pneumonitis grade > 1. Other inclusion/exclusion criteria may apply

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.