Roche trials database

Trial information

A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

Status:

Completed

Protocol number:

ML20569

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

STUDY OF TARCEVATM (ERLOTINIB) IN PATIENTS WITH ADVANCED STAGE NON-SMALL- CELL LUNG CANCER IN FIRST OR SECOND LINE THERAPY

Brief summary:

This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 5.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Open label; Single group; Safety/efficacy study

Conditions:

• Non-Small Cell Lung Cancer

Primary outcome:

1. Incidence of adverse events (AEs) Time frame: Length of patient on study (length of time of patient on study determined by investigator)

Key secondary outcomes:

1. Best Response Rate per investigator assessment Time frame: Length of patient on study (length of time of patient on study determined by investigator)
2. Time to Progression (TTP) Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
3. Overall survival Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Inclusion criteria:

• adult patients >= 18 years of age;
• inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
• ECOG performance status of 0-3;
• previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

Exclusion criteria:

• prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
• unstable systemic disease;
• any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
• any significant ophthalmologic abnormality.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A N/A

Accepts healthy volunteers:

No

Anticipated start date:

June, 2009

Trial registration date:

09.09.2008

Date last updated:

10.06.2013

This trial was conducted at the following locations:

Russian Federation

• BALASHIKHA

RUSSIAN FEDERATION

• Krasnoyarsk

Link to trial result