This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Target EGFR
Sponsor Hoffmann-La Roche
Start date December 2013
End date June 2017
Trial size 144 participants
Trial identifier NCT01723878, ML28361


This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
time frame: 3 years

Secondary Outcomes

Objective response rate, tumor assessments according to RECIST v1.1 criteria
time frame: 3 years
One-year overall survival (from initiation of treatment to 12 months after disease progression)
time frame: 3 years
Time to progression
time frame: 3 years
Exposure (dosage/duration) with first-line Tarceva in clinical practice
time frame: 3 years
Safety: Incidence of adverse events
time frame: 3 years
Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression
time frame: 3 years
Treatments used after disease progression in clinical practice
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria - EGFR mutation-positive disease according to local laboratory testing - Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice Exclusion Criteria: - Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva - Participation in another clinical study - Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment

Additional Information

Official title Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.