| General information |
| Database: | DB00851 |
| Objective: | Epidermal growth factor receptor tyrosine kinase inhibitors (TKIs) administered concurrently with chemotherapy did not improve outcome in non small cell lung cancer (non small cell lung cancer). however, in preclinical models and earlyphase noncomparative studies, pharmacodynamic separation of chemotherapy and TKIs did show a synergistic effect. |
| Authors: | Aerts JG, et al |
| Title: | A randomizedphase II study comparing erlotinib versus erlotinib with alternating chemotherapy in relapsed non small cell lung cancer patients: the NVALT10 study. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23986090 |
| Trial Design |
| Clinical Trial Id: | NCT00835471 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Erlotinib+chemotherapy |
| Study Type: | A randomizedphase II study |
| Key Patients Feature: | patients with advanced non small cell lung cancer who had progressed on or following firstline chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Erlotinib versu Erlotinib+chemotherapy |
| Treatment Info: | Erlotinib 150 mg daily (monotherapy) or erlotinib 150 mg during 15 days intercalated with four 21day cycles docetaxel for squamous (SQ) or pemetrexed for nonsquamous (NSQ) patients was administered (combination therapy). After completion of chemotherapy, erlotinib was continued daily |
| Primary End Point: | Primary end point was progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 231 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 54% versus 39% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.9 months (95% CI 4.2-6.3 months) for patients treated with erlotinib monotherapy and 6.1 months (95% CI 4.7-7.9 months) for the combination arm |
| Median OS A vs. C: | 5.5 months (95% CI 4.5-8.5 months) versus 7.8 months (95% CI 6.5-10.8 months) for monotherapy versus combination therapy, respectively (adjusted logrank, P = 0.01; HR = 0.67, 95% CI 0.49-0.91) |
| Adverse Event(agent arm): | Hematological toxic effect was observed in the combination arm only, with febrile neutropenia in 6% of patients; 4% in the pemetrexed treated cohort and 10% in the docetaxel treated cohort. Toxic deaths were not observed in this study. |
| Conclusions: | PFS was not significantly different bettheyen the arms. OS was significantly improved in the combination arm, an effect restricted to NSQ histology. |