A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung cancer

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 18.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002569-39-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-27
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

- Confirmed c-MET pathway dysregulation
- EGFR mutated NSCLC patient who have developed acquired resistance to EGFR inhibitor treatment
- Measurable disease as determined by RECIST version 1.1
-ECOG performance status =2
- Documented c-Met amplification
- Prior clinical benefit on EGFR inhibitors and then subsequent progression
- = 18 years of age
- Life expectancy =3 months
Other protocol inclusion criteria may apply
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous treatment with a c-MET inhibitor or HGF-targeting therapy
Patients with documented EGFR T790M mutation
- Previous radiation therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1
- history of cystic fibrosis
- history of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis.
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
- Unable to swallow tablets once or twice daily
- Any unresolved toxicity from previous anticancer therapy greater than Grade 1 except alopecia.
- Unable to undergo an MRI or CT procedures
- Known history of HIV
- Undergone a bone marrow or solid organ transplant
- Pregnant or nursing

Other protocol exclusion criteria may apply

Study & Design

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