Phase 2
Completed N=17
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Source: ClinicalTrials.gov NCT00518011 ↗Enrolled (actual)
17
Serious AEs
68.8%
Results posted
Apr 2016
Primary outcomePrimary: Progression Free Survival — 23.3; 24.4 Week — p=0.3644
Summary
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
23.3; 24.4 | 0.3644 |
| SECONDARY Objective Response Rate |
0; 28.6 | — |
| SECONDARY Disease Control Rate |
50; 85.7 | — |
| SECONDARY Duration of Response |
16.3 | — |
| SECONDARY Overall Survival |
21.1; 39.0 | 0.7165 |
| SECONDARY Mean Change in Pulse Rate From Baseline |
2.37; 3.00; 3.00; -3.00; 2.75; -1.80 | — |
| SECONDARY Mean Change in Blood Pressure From Baseline |
3.00; -0.87; -6.87; -5.37; -4.85; -17.83 | — |
| SECONDARY Mean Change in Body Temperature From Baseline |
-0.02; -0.012; 0.14; -0.30; -0.07; -0.32 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
- ECOG PS 2;
- adequate organ function.
Exclusion Criteria
- prior chemotherapy or systemic anti-tumor therapy;
- hypersensitivity to erlotinib;
- any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
Data sourced from ClinicalTrials.gov (NCT00518011). 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.