Back to resultsARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Primary Purpose
Non-small-cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ARQ 197
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring NSCLC, c-MET, EGFR mutation-positive, gefitinib, erlotinib, EGFR-TKI resistance
Eligibility Criteria
Key Inclusion Criteria:
- Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
- Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
Key Exclusion Criteria:
- Prior therapy with a c-Met inhibitor.
- Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
- Major surgical procedure within 4 weeks prior to randomization
- Known symptomatic brain metastases.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARQ 197
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
Secondary Outcome Measures
To examine the progression free survival
To examine the progression free survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
To examine the overall survival
To examine the overall survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
To examine the disease control rate
To examine the disease control rate of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
To estimate the safety profile
To estimate the safety profile of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01580735
Brief Title
ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Official Title
A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
NSCLC, c-MET, EGFR mutation-positive, gefitinib, erlotinib, EGFR-TKI resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARQ 197
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ARQ 197
Intervention Description
ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM)
erlotinib: 150 mg qd
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
To examine the progression free survival
Description
To examine the progression free survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Time Frame
30 months
Title
To examine the overall survival
Description
To examine the overall survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Time Frame
30 months
Title
To examine the disease control rate
Description
To examine the disease control rate of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Time Frame
30 months
Title
To estimate the safety profile
Description
To estimate the safety profile of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function
Key Exclusion Criteria:
Prior therapy with a c-Met inhibitor.
Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
Major surgical procedure within 4 weeks prior to randomization
Known symptomatic brain metastases.
Facility Information:
City
Arakawa-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
27843623
Citation
Azuma K, Hirashima T, Yamamoto N, Okamoto I, Takahashi T, Nishio M, Hirata T, Kubota K, Kasahara K, Hida T, Yoshioka H, Nakanishi K, Akinaga S, Nishio K, Mitsudomi T, Nakagawa K. Phase II study of erlotinib plus tivantinib (ARQ 197) in patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer just after progression on EGFR-TKI, gefitinib or erlotinib. ESMO Open. 2016 Jul 21;1(4):e000063. doi: 10.1136/esmoopen-2016-000063. eCollection 2016.
Results Reference
derived
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ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
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