Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib (ATTENTION)

This study has been terminated.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd Identifier:
First received: June 17, 2011
Last updated: December 5, 2016
Last verified: December 2016
The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.

Condition Intervention Phase
Non-small-cell Lung Cancer
Drug: ARQ 197 and Erlotinib
Drug: Placebo and Erlotinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Progression free survival
  • Objective response rate
    Each assessment will be determined based on RECIST criteria version 1.1 by investigator

  • Number of patients with adverse events

Study Start Date: July 2011
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197
ARQ 197 and Erlotinib
Drug: ARQ 197 and Erlotinib
Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
Placebo Comparator: Placebo
Placebo and Erlotinib
Drug: Placebo and Erlotinib
Oral twice daily administration of placebo and oral once daily administration of erlotinib


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Male or female at least 20 years of age with life expectancy ≥ 3 months
  2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay
  3. Evaluable disease according to RECIST, Version 1.1
  4. 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
  5. ECOG performance status of 0 or 1
  6. Demonstrate adequate bone marrow, liver, and renal functions, defined as:

    • ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, ANC ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥9.0 g/dL, and serum creatinine ≤1.5 mg/dL.

  7. Voluntary written informed consent form before performance of any study-specific procedures or tests

Exclusion Criteria

  1. Prior therapy with an EGFR inhibitor and/or tivantinib
  2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization
  3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization
  4. Major surgical procedure within 4 weeks prior to randomization
  5. History of cardiac disease
  6. Known symptomatic brain metastases
  7. Need to breastfeed a child during or within 12 weeks of completing the study
  8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib
  9. History of malignancy other than NSCLC
  10. Known infection with HIV, active HBV or HCV
  11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases
  12. Psychiatric disease that could affect the informed consent process
  13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective
  14. Positive serum or urine pregnancy test in female subjects of childbearing potential
  15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01377376

Osaka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01377376     History of Changes
Other Study ID Numbers: ARQ197-006
Study First Received: June 17, 2011
Last Updated: December 5, 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017