An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Tracking Information

Start Date  ICMJENovember 2004
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Safety:Adverse events, serious adverse events, premature withdrawals [ Time Frame: At each clinic visit, throughout study.Length of study not specified ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00949910 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 15, 2009)
Efficacy: Response rate, time to progression, survival [ Time Frame: At each clinic visit, throughout study. length of study not specified ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEAn Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJEAn Open-label, Expanded-access Study of the Effect of Tarceva on Treatment Response in Patients With Advanced Stage IIIB/IV Non-small-cell Lung Cancer
Brief Summary

This study will provide treatment with Tarceva to patients with advanced NSCLC who have received >=1 course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. The anticipated time on study treatment is as long as the patient is, in the investigator's opinion, benefiting from the therapy and the target sample size is 500+ individuals.

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJENon-small Cell Lung Cancer
Intervention  ICMJEDrug: erlotinib
Other Name: Tarceva
Study Arms / Comparison Groups1: Experimental
Intervention: Drug: erlotinib

Recruitment Information

Estimated Enrollment  ICMJE7041
Estimated Completion DateMarch 2013
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC;
  • previous treatment with <=2 prior chemotherapy regimens.

Exclusion Criteria:

  • previous systemic anti-cancer therapy with HER1/EGFR inhibitors;
  • inability to take oral medication;
  • any other malignancies within 5 years.
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MO18109888-662-6728 (U.S. Only)
Location Countries  ICMJEAlbania,   Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Ecuador,   Egypt,   Estonia,   Finland,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   India,   Indonesia,   Ireland,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Panama,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Uruguay,   Venezuela

Administrative Information

Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMO18109
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche