An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 6,586
- Primary Endpoint
- Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Erlotinib
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.
Intervention: Erlotinib (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: 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
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.
Secondary Outcomes
- Percentage of Participants With Disease Control According to RECIST(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(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(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(Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter)
- Percentage of Participants With Death or Disease Progression According to RECIST(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)
- Overall Survival (OS)(Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter)