Phase 2
Completed N=52
A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy
Source: ClinicalTrials.gov NCT02013206 ↗Enrolled (actual)
52
Serious AEs
42.9%
Results posted
Dec 2014
Primary outcomePrimary: Non-Progression Rate (NPR) at 8 Weeks — 41.4; 65.2 percentage of participants
Summary
This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-Progression Rate (NPR) at 8 Weeks |
41.4; 65.2 | — |
| SECONDARY Objective Response Rate |
17; 35 | — |
| SECONDARY Disease Control Rate |
41; 65 | — |
| SECONDARY Duration of Response |
13.1; 5.7 | — |
| SECONDARY Time to Progression |
1.9; 5.5 | — |
| SECONDARY Progression-Free Survival |
1.9; 4.1 | — |
| SECONDARY Overall Survival |
9.9; 13.9 | — |
| SECONDARY Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
26; 23; 14; 7 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- no previous chemotherapy.
Exclusion Criteria
- previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
- clinical evidence of brain metastasis;
- any unstable systemic disease;
- unable to take oral medication;
- any significant ophthalmological abnormality.
Data sourced from ClinicalTrials.gov (NCT02013206). 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.