Phase 2
N=247
A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer
Non-Small-Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00550173 ↗Enrolled (actual)
247
Serious AEs
27.0%
Results posted
Feb 2013
Primary outcome: Primary: Progression-Free Survival (PFS) — 7.4; 3.8; 4.4 months — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug); erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
7.4; 3.8; 4.4 | 0.003 sig |
| SECONDARY Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)] |
44.7; 29.3; 10.0 | <0.001 sig |
| SECONDARY Overall Survival (OS) |
20.5; 22.8; 17.7 | 0.194 |
| SECONDARY Number of Participants With Adverse Events |
25; 18; 22; 72; 76; 67 | — |
| SECONDARY Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR) |
64.5; 52.4; 56.3 | 0.306 |
| SECONDARY Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS) |
1.0; 0.8; 1.5 | 0.013 sig |
| SECONDARY Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status |
7; 8; 9; 10; 6; 3 | 0.040 sig |
| SECONDARY Probability of OS at 12 Months |
40.2; 26.2; 18.1 | — |
Summary
The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.
Eligibility Criteria
Inclusion Criteria
- Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
- Patients must be non-smokers
- Patients must have at least one measurable lesion
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
- Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.
Exclusion Criteria
- Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
- Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
- Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
- Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
- Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed
Data sourced from ClinicalTrials.gov (NCT00550173). 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.