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Tyrosine Kinase Inhibitor

Phase II- Group 3 (EGFRmut, T790M negative, any MET, 1L antineoplastic) for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants in Phase Ib and Phase II Groups 1 to 4 with histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or metastatic (Stage IV) NSCLC Participants in Phase II Group 5 must have stage IIIB/IIIC (not amenable to curative surgery, chemoradiation or radiation) or stage IV NSCLC
Patients must be screened for HCV. Patients must have negative hepatitis C antibody (HCV Ab) or are HCV Ab positive but with an undetectable level of HCV-RNA. Note: patients with detectable HCV-RNA are not eligible for the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years (while on inc280 monotherapy)
Awards & highlights

Study Summary

This trial is testing a new cancer drug combo to see what dose is safe and how well it works against lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years (while on inc280 monotherapy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years (while on inc280 monotherapy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II Group 1, 2 and 3: Overall Response Rate (ORR) by Investigator's Assessment Per RECIST 1.1
Phase II Group 4: Dose Intensity
Phase II Group 4: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
+3 more
Secondary outcome measures
Phase II Group 1, 2 3 and 4: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator's Assessment
Phase II Group 1, 2 and 3: Dose Intensity
Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618
+30 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L, EGFR TKI resistant)Experimental Treatment2 Interventions
NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants were to start with INC280 monotherapy (twice a day) and would have had the opportunity to continue to combination of EGF816 (once a day) and INC280 (twice a day) based on radiological disease progression evaluation by investigator's assessment per RECIST 1.1
Group II: Phase II- Group 4 (EGFRmut, any T790M, any MET, 1L (treatment naïve) 2-3L antineoplastic)Experimental Treatment2 Interventions
NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who were treatment naïve or failed maximum 2 prior lines of any systemic antineoplastic therapy for advanced disease. Participants were treated at the RP2D of INC280 and EGF816 in fed state
Group III: Phase II- Group 3 (EGFRmut, T790M negative, any MET, 1L antineoplastic)Experimental Treatment2 Interventions
NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic systemic therapy prior to study entry. Participants were treated at the RP2D of INC280 and EGF816 in fasted state
Group IV: Phase II- Group 2 (EGFRmut, de novo T790M, any MET, 1/3L antineoplastic, EGFR TKI naïve)Experimental Treatment2 Interventions
NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who are treatment naïve or received maximum 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated at the RP2D of INC280 and EGF816 in fasted state
Group V: Phase II- Group 1 (EGFRmut, any T790M, any MET, 2/4L antineoplastic, EGFR TKI resistant)Experimental Treatment2 Interventions
NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received one to three lines of systemic antineoplastic therapy prior to study entry including one line maximum of first or second generation EGFR TKI and who progressed on this EGFR TKI treatment line. Participants were treated at the RP2D of INC280 and EGF816 in fasted state
Group VI: Phase IB part- NSCLC with EGFR activating mutationsExperimental Treatment2 Interventions
NSCLC participants who have previously documented EGFR mutation and progressed on EGFR TKI treatment. Participants were treated at a starting dose of 50 mg once a day for EGF816 and 200 mg twice a day for INC280 in fasted state
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
2021
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,401 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~17 spots leftby Mar 2025