A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: erlotinib [Tarceva]

• Registration Number: NCT01996332
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-27
• Status Verified: 2014-06
• Results First Submitted: 2014-06-09
• Results First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Results First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1805

Inclusion Criteria

• adult patients >=18 years of age;
• locally advanced or metastatic NSCLC (Stage IIIB or IV);
• not a candidate for curative surgery or radical chemotherapy;
• no brain metastases, or clinically stable metastases for >=2 months.

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Exclusion Criteria

• radiotherapy over the previous 2 weeks;
• weight loss >10% in the previous 6 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tarceva Arm	erlotinib [Tarceva]	-

Primary Outcome Measures

Name	Time	Method
Time to Disease Progression or Death by Line of Treatment	Baseline, every 6-8 weeks up to 3 years until disease progression or death	Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) by Line of Treatment	Baseline, every 6-8 weeks up to 3 years, or until death	Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date was unavailable\] minus the date of first dose of study medication plus 1 divided by 30.44).
Percentage of Participants Achieving Clinical Benefit by Line of Treatment	Baseline, every 6-8 weeks up to 3 years or until death	Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response \[CR\], partial response \[PR\], or stable disease \[SD\]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.