N/A
Completed N=347
An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer
Nonsquamous Nonsmall Cell Neoplasm of Lung
Source: ClinicalTrials.gov NCT01161173 ↗
Enrolled (actual)
347
Serious AEs
60.5%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) — 0.8; 3.7; 48.2; 47.3 Percentage of participants
Summary
This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) |
0.8; 3.7; 48.2; 47.3 | — |
| SECONDARY Time to Disease Progression |
3.6 | — |
| SECONDARY Progression-free Survival |
2.7 | — |
| SECONDARY Overall Survival |
7.1 | — |
| SECONDARY Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores |
0.15; 0.20; -0.09 | — |
| SECONDARY Percentage of Participants Who Developed Rash |
63.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 18 years of age.
- Written informed consent.
- Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
- Measurable disease (Response Evaluation Criteria In Solid Tumors).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Prior course of standard systemic chemotherapy.
Exclusion Criteria
- Contra-indications to treatment with Tarceva.
Data sourced from ClinicalTrials.gov (NCT01161173). 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.