N/A
Completed N=57
An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy
Source: ClinicalTrials.gov NCT01664533 ↗Enrolled (actual)
57
Serious AEs
29.8%
Results posted
Dec 2015
Primary outcomePrimary: Progression-free Survival — 1.8 Months
Summary
This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
1.8 | — |
| SECONDARY Best Overall Response |
0.0; 0.0; 34.6; 65.4 | — |
| SECONDARY Overall Survival |
5.8 | — |
| SECONDARY Percentage of Participants Who Developed Rash |
60.7 | — |
| SECONDARY Percentage of Participants Who Developed Diarrhea |
42.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 18 years of age.
- Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
- Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).
Exclusion Criteria
- Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
- Contraindication for Tarceva according to the Summary of Product characteristics.
Data sourced from ClinicalTrials.gov (NCT01664533). 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.