Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)

NCT03240393 | Withdrawn Phase 2

• 1 other identifier: CINC280A2202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

Conditions

Carcinoma; Non-Small-Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; NSCLC; INC280; EGFR wild-type (wt); advanced non-small cell lung cancer; advanced/metastatic disease; Non-small cell lung carcinoma (NSCLC); treatment of lung cancer after first metastasis; lung cancer; lung adenocarcinoma; Non small cell lung carcinoma; Non-small cell lung cancer; MET exon 14 deletion; MET exon 14 skipping; MET exon 14 mutation; MET mutation; MET amplification; MET inhibitor; MET dysregulation; MET activation; MET signaling; MET pathway; MET; cMET

Outcome Measures

Primary Outcomes (1)

• ORR based on Central Radiology review/assessment (BIRC)

  Proportion of patients with a best overall response defined as complete response (CR) or partial response (PR) by Blinded Independent Review Committee (BIRC) assessment per RECIST 1.1

  at least 18 weeks

Secondary Outcomes (16)

• Duration of Response (DOR) by BIRC - Key Secondary

  at least 18 weeks

• ORR by Investigator

  at least 18 weeks

• Duration of Response (DOR) by investigator

  at least 18 weeks

• Time to Response (TTR) by BIRC

  at least 18 weeks

• Time to Response (TTR) by investigator

  at least 18 weeks

Study Arms (3)

cMET GCN ≥ 6

EXPERIMENTAL

Pre-treated patients with cMET GCN ≥ 6 treated with INC280 at 400mg BID

Drug: INC280

cMET GCN ≥ 4 and < 6

EXPERIMENTAL

Pre-treated patients with cMET GCN ≥ 4 and \< 6 treated with INC280 at 400 mgBID

Drug: INC280

cMET mutations

EXPERIMENTAL

Pre-treated patients with cMET mutations regardless of cMET GCN treated with INC280 at 400mg BID

Drug: INC280

Interventions

INC280 DRUG

cMET GCN ≥ 6 cMET GCN ≥ 4 and \< 6 cMET mutations

Also known as: capmatinib

cMET GCN ≥ 4 and < 6; cMET GCN ≥ 6; cMET mutations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IIIB or IV NSCLC (any histology) at the time of study entry
• Histologically or cytologically confirmed diagnosis of NSCLC that is:
• EGFR wt as per patient standard of care by a validated test
• AND ALK-negative rearrangement as part of the patient standard of care by a validated test
• AND (by central assessment) either:
• Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
• Cohort 2: Pre-treated patients with cMET GCN ≥4 and \< 6, or
• Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
• Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
• At least one measurable lesion as defined by RECIST 1.1
• Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
• Patients must have adequate organ function
• ECOG performance status (PS) of 0 or 1

You may not qualify if:

• Prior treatment with crizotinib, or any other cMET or HGF inhibitor
• Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
• Patients with characterized ALK-positive rearrangement
• Clinically significant, uncontrolled heart diseases.
• Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
• Strong and moderate inhibitors of CYP3A4
• Strong inducers of CYP3A4
• Impairment of GI function or GI disease that may significantly alter the absorption of INC280
• Patients receiving treatment with any enzyme-inducing anticonvulsant
• Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
• Pregnant or nursing women
• Women of child-bearing potential, unless they are using highly effective methods of contraception
• Sexually active males unless they use a condom during intercourse

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms; Adenocarcinoma of Lung

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 7, 2017
• Study Start: July 31, 2018
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: July 26, 2018

Record last verified: 2018-07