N/A
Completed N=156
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
Source: ClinicalTrials.gov NCT02133508 ↗Enrolled (actual)
156
Serious AEs
12.8%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 — 17.9 percentage of participants
Summary
This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed from the start of treatment for 8 months or until death. The extension of the retrospective versus prospective observation will depend on the lag between the date of the participant enrollment and the date of beginning of erlotinib therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
17.9 | — |
| PRIMARY Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
3.8; 45.5; 28.8; 3.8 | — |
| SECONDARY Progression-free Survival (PFS) According to RECIST v1.1 |
271.0 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
71.2 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with stage IIIb or IV NSCLC
- Participants aged >/= 18 years
- Second-line treatment with Tarceva started before study inclusion and SD response, or CR/PR according to RECIST v1.1, lasting for at least 4 weeks
Exclusion Criteria
- Known presence of epidermal growth factor receptor (EGFR) mutation
- Participation in a clinical trial with Tarceva during the study observation period
Data sourced from ClinicalTrials.gov (NCT02133508). 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.