At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic, unresectable, or locally-advanced NSCLC
- ✓Disease progression during or after exactly one platinum-based chemotherapy regimen for advanced disease (stage IIIB or IV)
- ✓Bidimensionally measurable disease per protocol criteria
- ✓Karnofsky performance status 60-100
- ✕Pregnant or breastfeeding women
- ✕Dementia, altered mental status, or psychiatric condition prohibiting informed consent
- ✕Serious uncontrolled medical disorder impairing ability to receive protocol therapy
- ✕Symptomatic or uncontrolled brain metastases (patients on glucocorticoids for brain mets excluded; anticonvulsant users eligible)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase III Study of Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer After Platinum-Based Therapy
In Brief
A Phase 3 clinical trial evaluating Pemetrexed, Cetuximab, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 939 participants across 67 sites in 2 countries.
Detailed Summary
This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).
Study Details
Timeline
Interventions
Pemetrexed 500 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
Cetuximab 400/250 mg/m\^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.
Docetaxel 75 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.