Phase 2
Completed N=19
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer Metastatic
Source: ClinicalTrials.gov NCT00701558 ↗
Enrolled (actual)
19
Serious AEs
10.5%
Results posted
May 2016
Primary outcomePrimary: Time to Disease Progression — 15 weeks
Summary
This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression |
15 | — |
| PRIMARY Overall Response Rate (ORR) |
15.8 | — |
| SECONDARY Overall Survival |
39 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
- no previous systemic chemotherapy, radiation therapy or immunotherapy;
- Eastern Cooperative Oncology Group (ECOG) >=2.
Exclusion Criteria
- prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
- active, non-controlled systemic disease;
- any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
Data sourced from ClinicalTrials.gov (NCT00701558). 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.