Phase 2
Completed N=50
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)
Source: ClinicalTrials.gov NCT01378962 ↗Enrolled (actual)
50
Serious AEs
20.0%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death at 12 Months After Baseline — 42 percentage of participants
Summary
This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death at 12 Months After Baseline |
42 | — |
| PRIMARY Progression-Free Survival (PFS) |
12.58 | — |
| PRIMARY Probability of Being Progression Free 12 Months After Baseline |
0.51 | — |
| SECONDARY Percentage of Participants Who Died |
28 | — |
| SECONDARY Overall Survival (OS) |
17.48 | — |
| SECONDARY Percentage of Participants With a Response by Best Overall Response |
6; 62; 12; 4; 16 | — |
| SECONDARY Percentage of Participants With Objective Response |
68 | — |
| SECONDARY Percentage of Participants Achieving CR, PR, or SD as Best Overall Response |
80 | — |
| SECONDARY Percentage of Participants With Primary and Secondary Resistance |
8.33; 91.67 | — |
| SECONDARY Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type |
0.00; 51.11; 2.22; 15.56; 0.00; 50.00 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Locally advanced or metastatic non-small cell lung cancer
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy over >/=12 weeks
- Adequate hematological, liver, or kidney function
Exclusion Criteria
- Previous therapy against epidermal growth factor receptor for metastatic disease
- Treatment with investigational drug during the 3 weeks before enrollment
- History of neoplasm
- Patients with symptomatic cerebral metastases
- Unstable systemic disease
Data sourced from ClinicalTrials.gov (NCT01378962). 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.