Phase 3
Completed N=1,250
A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors
Source: ClinicalTrials.gov NCT00373425 ↗Enrolled (actual)
1,250
Serious AEs
21.1%
Results posted
Jun 2014
Primary outcomePrimary: Disease Free Survival (DFS) — 50.5; 48.2 months — p=0.3235
Summary
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival (DFS) |
55.0; 56.2 | 0.5620 |
| PRIMARY Disease Free Survival (DFS) |
55.0; 56.2 | 0.5620 |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Disease-free Survival in Participants With EGFR Mutation - Positive Tumors |
47.8; 28.5 | — |
| SECONDARY Disease-free Survival in Participants With EGFR Mutation - Positive Tumors |
47.8; 28.5 | — |
| SECONDARY Overall Survival in Participants With EGFR Mutation - Positive Tumors |
NA; NA | — |
| SECONDARY Overall Survival in Participants With EGFR Mutation - Positive Tumors |
NA; NA | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
599; 307; 279; 96; 118; 79 | — |
Eligibility Criteria
Inclusion Criteria
- Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests
- Patients may have up to 4 cycles of chemotherapy after surgery
- Complete removal of the tumor by surgery
- Able to start drug under the following timelines:
- 6 months from the day of surgery for patients who get chemotherapy
- 3 months from the day of surgery for those who do not get chemotherapy
- Confirmed diagnosis of Stage IB-IIIA NSCLC
- Patients must be accessible for follow-up visits
Exclusion Criteria
- History of prior radiotherapy for NSCLC either before or after surgery
- History of heart disease or uncontrolled heart arrhythmias within the previous year
- History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug
- History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years
- Patients who have received chemotherapy for NSCLC before surgery
- Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.
Data sourced from ClinicalTrials.gov (NCT00373425). 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.