Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Resected Carboplatin Docetaxel Bevacizumab Erlotinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief summary:
Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Docetaxel/Carboplatin/Bevacizumab/Erlotinib intervention 2: Docetaxel/Carboplatin
Intervention descriptions: intervention 1: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1

Docetaxel should be administered before carboplatin.

After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:

Maintenance Treatment for patients in Cohort A:

Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily

Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. intervention 2: Adjuvant Treatment Cohort B:

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1

Docetaxel should be administered before carboplatin.

Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.

Protocol document: