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A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor


Phase 3
20 Years
N/A
Open (Enrolling)
Both
Non-small-cell Lung Cancer

Thank you

Trial Information

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor


Inclusion Criteria:



- Histologically or cytologically confirmed surgically unresectable locally advanced or
metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type EGFR.

- Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
criteria, Version 1.1.

- Received one or two prior lines of systemic anti-cancer therapy for advanced or
metastatic disease, one of which must be a platinum-based therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Prior therapy with an EGFR inhibitor and/or c-Met inhibitor.

- Any systemic anti-tumor treatment for NSCLC within 4 weeks prior to randomization.

- Major surgical procedure within 4 weeks prior to randomization

- Known symptomatic brain metastases.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ARQ197-006

NCT ID:

NCT01377376

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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