A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)
Overview
- Phase
- Phase 3
- Intervention
- Erlotinib [Tarceva]
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 315
- Primary Endpoint
- Progression-Free Survival (PFS) at the End of Study
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients aged ≥18 years
- •inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
- •Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy ≥12 weeks
- •Current cigarette smoker (having smoked \>100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study
Exclusion Criteria
- •Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
- •Radiotherapy within 28 days prior to enrollment
- •Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
Arms & Interventions
Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Intervention: Erlotinib [Tarceva]
Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Intervention: Erlotinib [Tarceva]
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) at the End of Study
Time Frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Progression-Free Survival (PFS)
Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Secondary Outcomes
- Overall Response Rate (ORR)(Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months))
- Overall Survival (OS) at the End of Study(Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months))
- Time to Progression (TTP)(Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months))
- Overall Survival (OS)(Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months))
- Disease Control Rate (DCR)(Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months))
- Number of Participants With Adverse Events (AEs) at the End of the Study(Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months))