A Phase 1 interventional study of INC280 single agent and erlotinib in Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals. Terminated at 32 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.
The decision was taken to halt study enrollment with Cohort #3 in Phase Ib. Therefore, activities for the planned Phase II were not initiated.
This decision to stop further development of this combination was taken due to the challenge for enrollment in this very rare patient population along with the rapidly evolving disease landscape setting.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PhaseII : Prior treatment with any of the following agents:
Subjects who took INC280 200mg twice a day (BID) in combination with erlotinib (ERL) 150mg one a day (QD)
Drug: INC280 single agent · Drug: erlotinib
Subjects who took INC280 400mg twice a day (BID) in combination with erlotinib (ERL) 150mg one a day (QD)
Drug: INC280 single agent · Drug: erlotinib
Phase Ib: Frequency and characteristics of Dose Limiting Toxicity (DLTs) to the INC280 and erlotinib combination
To determine MTD and/or RP2D of INC280 in combination with erlotinib
Time frame: First 28 days of dosing
Phase Ib: Overall response rate (ORR)
ORR, proportion of patients with a best overall response of complete response or partial Response (CR+PR)
Time frame: Every 3 weeks, up to 5 years
Phase Ib: Disease Control Rate (DCR)
DCR, proportion of patients with best overall response of CR, PR or SD
Time frame: Every 6 weeks, up to 2 years
Phase Ib: Duration of Response (DOR)
DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause
Time frame: Every 6 weeks, up to 2 years
Phase Ib: Progression-free Survival (PFS)
PFS, defined as time from the first dose of study treatment to disease progression or death due to any cause
Time frame: Every 6 weeks, up to 2 years
Phase Ib: Number of patients with adverse events (AEs) as a measure of safety and tolerability
Safety and tolerability of INC280 in combination with erlotinib assessed by change in vital signs, laboratory results and electrocardiogram (ECG).
Time frame: Every 3 weeks, up to 2 years
Phase Ib: Plasma concentration-time profiles of INC280 and pharmacokinetic parameters
Composite pharmacokinetics of INC280 in the presence of erlotinib.
Time frame: 6 weeks
Phase Ib: Plasma concentration-time profiles of erlotinib in the presence of INC280
Composite pharmacokinetics of erlotinib in the presence of INC280.
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals