JDQ443 vs Docetaxel for Non-Small Cell Lung Cancer
(KontRASt-02 Trial)

Recruiting in Palo Alto (17 mi)

+144 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a phase III randomized 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.

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer that has a specific mutation (KRAS G12C) and who have already tried platinum-based chemo and immune therapy. They can't join if they've had certain lung conditions, other mutations like EGFR or ALK, active brain metastases, or previous treatment with docetaxel or KRAS G12C inhibitors.

Inclusion Criteria

You have at least one spot that can be measured or seen on a scan at the screening visit.

My cancer has a KRAS G12C mutation.

You have at least one spot that can be measured and evaluated by doctors.

+2 more

Exclusion Criteria

I haven't had docetaxel or KRAS G12C inhibitors for advanced cancer, or if I did, my cancer didn't worsen within 12 months after treatment.

My cancer has EGFR mutation or ALK rearrangement.

I have cancer that has spread to my brain or spinal cord.

+1 more

Participant Groups

The study compares JDQ443 alone to the chemotherapy drug docetaxel in patients whose lung cancer has worsened despite prior treatments. It's an open-label phase III trial where participants are randomly assigned to one of the two drugs.

2Treatment groups

Experimental Treatment

Active Control

Group I: JDQ443Experimental Treatment1 Intervention

Participants will be treated with JDQ443

Group II: DocetaxelActive Control1 Intervention

Participant will be treated with docetaxel following local guidelines as per standard of care and product labels

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Taxotere for: