Phase 3
N=217
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01342965 ↗Enrolled (actual)
217
Serious AEs
17.8%
Results posted
Feb 2015
Primary outcome: Primary: Investigator-assessed Duration of Progression-free Survival — 11.0; 5.5 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erlotinib (Drug); Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator-assessed Duration of Progression-free Survival |
11.0; 5.5 | — |
| SECONDARY Percentage of Responders as Assessed by the Investigator |
68.2; 39.3 | — |
| SECONDARY Percentage of Participants With Disease Control |
91.8; 82.2 | — |
| SECONDARY Duration of Response |
10.8; 4.2 | — |
| SECONDARY Overall Survival |
28.9; 27.1 | — |
| SECONDARY Safety: Incidence of Adverse Events |
— | — |
| SECONDARY Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire |
— | — |
Summary
This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.
Eligibility Criteria
Inclusion Criteria
- Adult participants, ≥ 18 years of age.
- Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
- Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
- European Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria
- Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
- Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
- Any inflammatory changes of the surface of the eye.
- ≥ Grade 2 peripheral neuropathy.
- History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
- Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
- Human immunodeficiency virus (HIV) infection.
- Pregnant, nursing, or lactating women.
Data sourced from ClinicalTrials.gov (NCT01342965). 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.