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

NCT01066884 | Completed Phase 4

• 1 other identifier: ML20569
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  Length of patient on study (length of time of patient on study determined by investigator)

Secondary Outcomes (3)

• Best Response Rate per investigator assessment

  Length of patient on study (length of time of patient on study determined by investigator)

• Time to Progression (TTP)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

• Overall survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Study Arms (1)

1

EXPERIMENTAL

Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva] DRUG

150mg po daily

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

Balashikha, 143900, Russia

Location

Unknown Facility

Krasnoyarsk, 660133, Russia

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 10, 2010
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

RU (2)