A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer.

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701558
• Other study ID #: ML20951
• Secondary ID: 2007-002135-83
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2008
• Last updated: March 1, 2016
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in chemotherapy-naive patients with unresectable, advanced and/or metastatic non-small cell lung cancer. Patients will receive Tarceva 150mg po daily, in combination with gemcitabine 1000mg/m2 i.v. weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;

• no previous systemic chemotherapy, radiation therapy or immunotherapy;

• ECOG >=2.

Exclusion Criteria:

• prior systemic anti-tumor therapy with HER1/EGFR inhibitors;

• active, non-controlled systemic disease;

• any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• erlotinib [Tarceva]
150mg po daily
• gemcitabine
1000mg/m2 i.v. weekly for 3 weeks of each 4 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression; pathological response rate.		Event driven	No
Secondary	Median and overall survival		Event driven	No
Secondary	AEs, laboratory parameters.		Throughout study	No