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

• Register: EUCTR
• Last refreshed on: 8 March 2021
• Main ID: EUCTR2014-003731-20-ES
• Date of registration: 09/01/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: 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
• Scientific title: A phase II, multicenter, open-label 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
• Date of first enrolment: 19/06/2015
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003731-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, France, Germany, Italy, Netherlands, Norway, Singapore, Spain, Switzerland, United States

Contacts

• Name: Departamento Médico Oncología (GMO)
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico Oncología (GMO)
• Affiliation: Novartis Farmacéutica, S.A.

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

EGFR mutated non-small cell lung cancer and cMet positive non-small cell lung cancer
MedDRA version: 17.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Code: INC280
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not applicable
CAS Number: 1197376-85-4
Current Sponsor code: INC280
Other descriptive name: INC280
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Product Code: INC280
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not applicable
CAS Number: 1197376-85-4
Current Sponsor code: INC280
Other descriptive name: INC280
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Code: EGF816
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not applicable
CAS Number: EGF816
Current Sponsor code: EGF816
Other descriptive name: EGF816
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Code: EGF816
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not applicable
CAS Number: EGF816
Current Sponsor code: EGF816
Other descriptive name: EGF816
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Code: EGF816
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not applicable
CAS Number: EGF816
Current Sponsor code: EGF816
Other descriptive name: EGF816
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: nivolumab
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: nivolumab
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558-01
Other descriptive name: BMS936558
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Code: INC280
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not applicable
CAS Number: 1197376-85-4
Current Sponsor code: I

Primary Outcome(s)

Secondary Objective: 1. To evaluate the preliminary antitumor activity of EGF816 and Nivolumab and of INC280 and Nivolumab
2. To characterize the safety and tolerability of EGF816 and Nivolumab or of INC280 and Nivolumab
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

Main Objective: To estimate the clinical activity of Nivolumab in combination with EGF816 or INC280

Secondary Outcome(s)

Secondary end point(s): 1. ORR, DCR, other PFS measures, OS
2. Safety, incidence of AEs and SAEs, including changes in hematology and chemistry values, vital signs and ECGs
Tolerability: Dose interruptions, reductions, and dose intensity
3. PK parameters of Nivolumab,EGF816 and INC280 such as Cmax, AUC and Cmin

Timepoint(s) of evaluation of this end point: 1. ORR, DCR, PFS : 3 month
OS: 1 year

2. Please refer to table 7.1 of the protocol

3. EGF816 and INC280 (safety monitoring cohort): D1,8,15 cycle 1, D1 cycle 2 then on D1 cycles 4,6,8
EGF816 and INC280 (after safety monitoring cohort): D15 cycle 1, D1 cycle 2 then on D1 cycles 4,6,8
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 ID(s)

2014-003731-20-DE

CEGF816X2201C

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 05/02/2015
Contact: