Trial information
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.
Status: Not yet recruiting
Protocol number: ML20951
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
Brief 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. Target sample size is 12.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Time to disease progression; pathological response rate. Time frame: Event driven
Key secondary outcomes: 1. Median and overall survival Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
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).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2008
Trial registration date: 06/18/2008
Date last updated: 8/19/2008
Link to trial result
This trial will be conducted at the following locations:
Romania
