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 (CEGF816X2201C)

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 (CEGF816X2201C) - CEGF816X2201C

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44688

Enrollment

Registered

2015-02-23

Start date

2015-05-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer (NSCLC)

Interventions

Treatment with nivolumab in combination with EGF816 or INC280.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Female and male patients * 18 years of age. * Advanced metastatic and/or unresectable NSCLC. * Measurable disease. * Group 1: confirmed T790M EGFR mutation. * Group 2: confirmed c-MET positive. * ECOG performance status 0, 1, 2.

Exclusion criteria

Exclusion criteria: * Group 1: More than one prior line of EGFR TKI therapy. * Group 2: Previous treatment with a c-MET inhibitor or HGFtargeting therapy. * Prior treatment with PD1/PD-L1 targeting therapies. * Patients who require emergent use of systemic steroids, emergent surgery and/or radiotherapy. * Interstitial lung disease. * Any active or history of autoimmune disease, hepatitis B virus or hepatitis C virus * Prohibited co-medication: see protocol page 46. * Pregnancy, lactation, inadequate contraception (males and females). See protocol page 30-31 for details. * Group 2: GI impariment resulting in altered absorption of INC280

Design outcomes

Primary

Measure	Time frame
Progression free survival 6 months.	—

Secondary

Measure	Time frame
Other progression free survivals, overall response rate, disease control rate and overall survival. Adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)