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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996332
• Other study ID #: ML17915
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2013
• Last updated: June 9, 2014
• Start date: April 2004
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espaniola de Medicamentos y Productos Sanitarios (AEMPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1805
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• radiotherapy over the previous 2 weeks;

• weight loss >10% in the previous 6 weeks.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• erlotinib [Tarceva]
150 mg/day until progressive disease or unacceptable toxicity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Disease Progression or Death by Line of Treatment	Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.	Baseline, every 6-8 weeks up to 3 years until disease progression or death	No
Secondary	Percentage of Participants Achieving Clinical Benefit by Line of Treatment	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.	Baseline, every 6-8 weeks up to 3 years or until death	No
Secondary	Overall Survival (OS) by Line of Treatment	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).	Baseline, every 6-8 weeks up to 3 years, or until death	No