Phase 3
N=375
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01667562 ↗Enrolled (actual)
375
Serious AEs
20.0%
Results posted
Dec 2019
Primary outcome: Primary: Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) — 9.574 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) |
9.574 | — |
| SECONDARY Proportion of Participants With Objective Response as Assessed by RECIST v 1.1 |
0.67 | — |
| SECONDARY Proportion of Participants With Disease Control as Assessed by RECIST v 1.1 |
0.97 | — |
| SECONDARY Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations |
0.08 | — |
| SECONDARY Percentage of Participants With Adverse Events |
76.7 | — |
| SECONDARY Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) |
-2.83 | — |
Summary
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
- Measurable disease according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematological, liver and renal function
- Participants with asymptomatic and stable cerebral metastases receiving medical treatment
Exclusion Criteria
- Previous chemotherapy or treatment against EGFR for metastatic disease
- Treatment with an investigational agent less than 3 weeks before enrollment
- History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
- Participants with symptomatic cerebral metastases
- Any significant ophthalmologic abnormality
- Unstable systemic disease
- Coumarins use
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
- Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
- Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
Data sourced from ClinicalTrials.gov (NCT01667562). 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.