Study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer

Phase 1

• Conditions: EGFR mutated non-small cell lung cancer and cMet positive non-small cell lung cancer; MedDRA version: 17.1Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003731-20-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-09
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

? Advanced metastatic and/or unresectable NSCLC
? Measurable disease as determined by RECIST version 1.1
? ECOG performance ?2
? Patients in Group 1: confirmed T790M EGFR mutation
? Patients in Group 2: confirmed c-MET positive

Other inclusion criteria may apply as per protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

? For Group 1: Patients who have received more than one prior line of EGFR TKI therapy
? For Group 2: Previous treatment with a c-MET inhibitor or HGF-targeting therapy
? Prior treatment with PD1/PD-L1 targeting therapies
? Subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy
? Patients with interstitial lung disease
? Patients with any active or history of autoimmune disease

Other exclusion criteria may apply as per protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the clinical activity of Nivolumab in combination with EGF816 or INC280;Secondary Objective: 1. To evaluate the preliminary antitumor activity of EGF816 and Nivolumab and of INC280 and Nivolumab<br>2. To characterize the safety and tolerability of EGF816 and Nivolumab or of INC280 and Nivolumab<br>3. To evaluate PK of EGF816, INC280 and Nivolumab in the combination setting;Primary end point(s): PFS rate using RECIST version1.1;Timepoint(s) of evaluation of this end point: 6 month

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. ORR, DCR, PFS : 3 month <br> OS: 1 year<br><br>2. Please refer to table 7.1 of the protocol<br><br>3. EGF816 and INC280 (safety monitoring cohort): D1,8,15 cycle 1, D1 cycle 2 then on D1 cycles 4,6,8<br>EGF816 and INC280 (after safety monitoring cohort): D15 cycle 1, D1 cycle 2 then on D1 cycles 4,6,8<br>Nivolumab (all patients): D15 cycle 1, D1 cycle 2 then on D1 cycles 4, 6, 8 then every 8th cycle after cycle 8 D1.;Secondary end point(s): 1. ORR, DCR, other PFS measures, OS<br>2. Safety, incidence of AEs and SAEs, including changes in hematology and chemistry values, vital signs and ECGs<br>Tolerability: Dose interruptions, reductions, and dose intensity<br>3. PK parameters of Nivolumab,EGF816 and INC280 such as Cmax, AUC and Cmin