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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason. | Drug: Erlotinib<br>* Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |