At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- ✓Recurrent or metastatic disease not amenable to curative therapy
- ✓Measurable disease by RECIST criteria
- ✓At least one prior platinum-containing chemotherapy regimen for locally advanced or metastatic disease
- ✕Active infection that would compromise ability to tolerate therapy
- ✕Serious concomitant systemic disorders that would compromise safety or ability to complete study
- ✕Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer disease-free ≥2 years
- ✕Major thoracic or abdominal surgery within 30 days of enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79
In Brief
A Phase 2 clinical trial evaluating Pemetrexed and Cetuximab for Non-Small Cell Lung Cancer. Completed, enrolled 36 participants across 11 sites.
Detailed Summary
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
Study Details
Timeline
Interventions
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle