Phase 2
N=84
Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
Adenocarcinoma · Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00137839 ↗Enrolled (actual)
84
Serious AEs
39.8%
Results posted
Nov 2019
Primary outcome: Primary: Overall Response Rate (ORR) — 27.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pasi A. Janne, MD, PhD
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
27.7 | — |
| SECONDARY Overall Response Rate (ORR) by EGFR Mutation Status |
56.4; 2.9; 0.0 | — |
| SECONDARY Overall Survival (OS) |
22.9 | — |
| SECONDARY Overall Survival by EGFR Mutation Status |
32.6; 9.9; 15.7 | — |
Summary
The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
- Female
- Diagnosis of adenocarcinoma of the lung
- Patient has had at least one core biopsy of her tumor
- Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
- Stage four (IV) or three (III) B non-small cell lung cancer
- Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
- Three or more weeks since last radiation therapy
- Three or more weeks since last major surgery
- Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
- Life expectancy of 8 weeks or more
- Blood tests that show kidneys, liver and bone marrow to be working adequately
- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study
Exclusion Criteria
- Prior exposure to Tarceva (OSI-774, erlotinib)
- Uncontrolled central nervous system problems
- Prior chemotherapy regimen
- Difficulty swallowing
- A disease or disorder that interferes with ability to digest and absorb food
- Incomplete healing of previous oncologic or other major surgery
- Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
- Pregnant or breast feeding
- A medical condition that could make it unsafe for patient to participate in this study
Data sourced from ClinicalTrials.gov (NCT00137839). 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.