EGF816 + Targeted Agents for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced EGFR-mutant NSCLC.

Eligibility Criteria

This trial is for adults with advanced EGFR-mutant NSCLC who haven't had treatment yet or have specific mutations after initial therapy. They must have a tumor that can be biopsied and agree to the procedure. Excluded are those in other drug studies, with unstable brain tumors, lung conditions like pneumonitis, HIV, recent certain therapies, uncontrolled heart disease, or another cancer history.

Inclusion Criteria

My cancer has specific genetic changes known as EGFR and T790M mutations.

My lung cancer is advanced or has spread, and tests show it has specific EGFR mutations.

I am willing to have a biopsy of my cancer.

Exclusion Criteria

Patients participating in additional parallel investigational drug or medical device studies.

I have or had lung conditions like interstitial lung disease.

I have had another type of cancer in the past.

Treatment Details

Interventions

• EGF816 (Tyrosine Kinase Inhibitor)
• Gefitinib (Tyrosine Kinase Inhibitor)
• INC280 (Tyrosine Kinase Inhibitor)
• LXH254 (Other)
• Ribociclib (Other)
• Trametinib (Other)

Trial Overview The study tests how safe and effective EGF816 is when combined with INC280, trametinib, ribociclib, gefitinib, or LXH254 in patients with advanced EGFR-mutant NSCLC. It aims to find out if adding these targeted agents improves outcomes for these patients.

Participant Groups

Group I: Arm G Experimental Treatment 2 Interventions

EGF816 + INC280 in expansion phase (patients with known resistance mechanism)

Group II: Arm F Experimental Treatment 2 Interventions

EGF816 + gefitinib in expansion phase

Group III: Arm E Experimental Treatment 2 Interventions

EGF816 + LXH254 in expansion phase (patients with known resistance mechanism)

Group IV: Arm D Experimental Treatment 2 Interventions

EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism)

Group V: Arm C Experimental Treatment 2 Interventions

EGF816 + ribociclib in expansion phase

Group VI: Arm B Experimental Treatment 2 Interventions

EGF816 + trametinib in expansion phase

Group VII: Arm A Experimental Treatment 2 Interventions

EGF816 + INC280 in expansion phase (patients with no known resistance mechanism)

Group VIII: Arm 3 Experimental Treatment 2 Interventions

EGF816 + LXH254 in escalation phase

Group IX: Arm 2 Experimental Treatment 2 Interventions

EGF816 + ribociclib in escalation phase

Group X: Arm 1 Experimental Treatment 2 Interventions

EGF816+ trametinib in escalation phase

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Novartis Investigative Site Toronto, Canada

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals Lead Sponsor

References