Phase 2
N=123
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01565538 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Progression-Free Survival — 4.1; 3.9 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib (Drug); Pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Si-Yu Wang
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
4.1; 3.9 | — |
| SECONDARY Best Tumor Response |
12; 5; 49; 57 | — |
| SECONDARY Overall Survival |
11.7; 13.4 | — |
Summary
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed Lung adenocarcinoma
- Wld-type EGFR
- Stage IIIB/IV
- Failure to prior chemotherapy
- Life expectancy of more than 3 months
- Tissue sample desired for genomic study
- Age ≥ 18 years
- Performance status (WHO) 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Informed consent
Exclusion Criteria
- Have previously received pemetrexed or TKIs
- Other concurrent uncontrolled illness
Data sourced from ClinicalTrials.gov (NCT01565538). 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.