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Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

NCT01244191 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1048

Last updated 2021-04-06

Study results available
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Summary

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

Conditions

  • Non Squamous, Non-small-cell Lung Cancer

Interventions

DRUG

Tivantinib

Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day

DRUG

Placebo

Tivantinib Placebo tablets given twice a day

DRUG

Erlotinib

Erlotinib 150 mg oral tablets, given once a day

Sponsors & Collaborators

  • ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

    collaborator INDUSTRY

  • Daiichi Sankyo

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-11
Primary Completion
2012-12-15
Completion
2012-12-15

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01244191 on ClinicalTrials.gov