Phase 4
N=51
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01230710 ↗Enrolled (actual)
51
Serious AEs
7.8%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Participants With Progression-free Survival at Week 52 — 22.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-free Survival at Week 52 |
22.5 | — |
| SECONDARY Progression-free Survival (PFS) |
99 | — |
| SECONDARY Overall Survival |
671 | — |
| SECONDARY Percentage of Participants With a Complete Response (CR) or a Partial Response (PR) |
2.1; 23.4 | — |
| SECONDARY Percentage of Participants With Disease Control |
55.3 | — |
Summary
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 18 years of age.
- Histologically documented non-small cell lung cancer (NSCLC).
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients of reproductive potential must agree to use effective contraception.
Exclusion Criteria
- Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- Prior treatment with any monoclonal antibody therapy.
- Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- Pre-existing interstitial lung disease.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT01230710). 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.