A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic nonsmall cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI) - Study of INC280 alone and in combination with erlotinib vs. chemotherapy in EGFR+/cMET amp NSCLC

ovartis Pharma Services AG0 sites23 target enrollmentFebruary 23, 2016

Conditionson-small cell lung cancer MedDRA version: 18.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)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]

DrugsTarceva Alimta

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on-small cell lung cancer
Sponsor: ovartis Pharma Services AG
Enrollment: 23
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 23, 2016

End Date

December 5, 2018

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•Specific for Phase Ib:
•? Must have received at least one line of systemic therapy, including one prior 1st generation (e.g., erlotinib, gefitinib) or 2nd generation (e.g., afatinib) EGFR TKI; any line of prior systemic chemotherapy is allowed
•? cMET\-amplification (GCN \= 6\) by FISH assessed from a biopsy or an archival tumor sample collected at or any time after the progression on prior 1st or 2nd generation EGFR TKI, determined locally or by a Novartis\-designated central laboratory. Patients with known EGFRT\-790M mutation are not eligible.
•? Adequate organ function at screening including platelet count \= 75 x 10^9/L
•Specific for Phase II:
•? Must have received one and only one prior line of 1st generation (e.g., erlotinib, gefitinib) or 2nd generation (e.g., afatinib) EGFR TKI for the treatment of locally advanced or metastatic NSCLC
•? No prior chemotherapy is allowed, except patients, who switched from platinum\-based chemotherapy to EGFR TKI during first line treatment within 28 days since the start date of chemotherapy, will be allowed to enter the study, in the absence of disease progression. Prior neoadjuvant/adjuvant cytotoxic chemotherapy is not allowed, unless the relapse occurred more than 12 months after the last administration of neoadjuvant/adjuvant chemotherapy
•? cMET\-amplification (GCN \= 6\) by FISH determined by a Novartis\-designated central laboratory on a newly obtained tumor biopsy (preferred) or an archival tumor sample obtained at or any time after the progression on prior 1st or 2nd generation EGFR TKI
•? EGFR\-T790M negative status assessed from a biopsy or an archival tumor sample collected at or any time after the progression on prior 1st or 2nd generation EGFR TKI, determined locally by either Roche Cobas or Qiagen therascreen test or by a Novartis designated central laboratory
•? Presence of at least one measurable lesion according to RECIST v1\.1\. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.

Exclusion Criteria

•Specific Phase II:
•? History of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs.
•? Prior treatment with any of the following agents: crizotinib, or any other cMET inhibitor or HGF\-targeting inhibitor, concomitant EGFR TKI and platinum based chemotherapy as first line regimen, platinum\-based chemotherapy as first line treatment
•Common for Phase Ib and Phase II:
•? Known hypersensitivity to any of the excipients of INC280
•? Prior treatment with any 3rd generation EGFR TKI (e.g., CO1686, AZD9192, EGF816\).
•? Symptomatic central nervous system (CNS) metastases
•? Presence or history of carcinomatous meningitis
•? 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)
•? Thoracic radiotherapy to lung fields \= 4 weeks prior to study enrollment or patients who have not recovered from radiotherapy\-related toxicities