Phase 3
Completed N=313
A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
Source: ClinicalTrials.gov NCT01183858 ↗Enrolled (actual)
313
Serious AEs
20.5%
Results posted
Feb 2015
Primary outcomePrimary: Progression-Free Survival (PFS) — 6.86; 7.00 weeks — p=0.671
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
6.86; 7.00 | 0.671 |
| PRIMARY Progression-Free Survival (PFS) at the End of Study |
6.86; 7.00 | 0.625 |
| SECONDARY Overall Survival (OS) |
6.77; 6.83 | — |
| SECONDARY Overall Response Rate (ORR) |
0.0; 0.0; 7.1; 2.5; 33.1; 34.0 | — |
| SECONDARY Disease Control Rate (DCR) |
40.3; 36.5 | — |
| SECONDARY Time to Progression (TTP) |
9.86; 9.14 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) at the End of the Study |
130; 141; 29; 35; 18; 15 | — |
| SECONDARY Overall Survival (OS) at the End of Study |
7.00; 6.90 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01183858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.