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A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

NCT01310036 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2018-09-12

Study results available
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Summary

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Erlotinib

Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-02-14
Completion
2016-12-30

Countries

  • Hong Kong
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

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 NCT01310036 on ClinicalTrials.gov