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A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

NCT01174563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-17

Study results available
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Summary

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

erlotinib [Tarceva]

150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

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
2011-05-23
Primary Completion
2016-12-20
Completion
2016-12-20

Countries

  • Israel

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 NCT01174563 on ClinicalTrials.gov