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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949910
• Other study ID #: MO18109
• Secondary ID: 2004-000564-28IN
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2009
• Last updated: October 4, 2016
• Start date: November 2004
• Est. completion date: April 2009

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board
• Study type: Interventional

Clinical Trial Summary

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6586
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults greater than or equal to (=) 18 years of age

• Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC

• Previous treatment with no more than 2 prior chemotherapy regimens

Exclusion Criteria:

• Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors

• Inability to take oral medication

• Any other malignancies within 5 years

Study Design

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
Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Albania,  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,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Panama,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  Slovenia,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Uruguay,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)	Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (=) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed =28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.	Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter	No
Secondary	Percentage of Participants With Disease Control According to RECIST	Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as =30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.	Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter	No
Secondary	Percentage of Participants by Best Overall Response According to RECIST	Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as =30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.	Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter	No
Secondary	Percentage of Participants With Death or Disease Progression According to RECIST	Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.	Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter	No
Secondary	Progression-Free Survival (PFS) According to RECIST	Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.	Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter	No
Secondary	Percentage of Participants Who Died	The percentage of participants (in nearest integer) who died from any cause was reported.	Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter	No
Secondary	Overall Survival (OS)	OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.	Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter	No