This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatment erlotinib [tarceva]
Phase phase 2
Sponsor Hoffmann-La Roche
Collaborator Clalit Health Services
Start date May 2011
End date December 2016
Trial size 60 participants
Trial identifier NCT01174563, ML25200


This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Patients 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 occurs.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
erlotinib [tarceva]
150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Primary Outcomes

Progression-free survival according to grade of rash; tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST criteria
time frame: up to 3 years

Secondary Outcomes

Rate of Tarceva dose reductions due to grade III-IV rash
time frame: approximately 3 years
Progression-free survival in patients with Tarceva dose reductions due to grade III-IV rash; tumor assessments by CT or MRI according to RECIST criteria
time frame: up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC) - Presence of epidermal growth factor receptor (EGFR) mutations - Previously untreated with any systemic anti-neoplastic therapy for advanced disease - Last dose of a prior systemic anti-neoplastic therapy for early-stage disease >/= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy Exclusion Criteria: - Pregnant or breast feeding women - Known allergy or other adverse reaction to study drug or any other related compound - Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy) - Newly diagnosed or not yet definitively treated (i.e. stable disease >/= 2 months) CNS metastases or spinal cord compression - Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study) - Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

Additional Information

Official title A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.