| General information |
| Database: | DB00808 |
| Objective: | Patients with stage III non small cell lung cancer and poor performance status and/or weight loss do not seem to benefit from standard therapy. Based on the preclinical interaction between epidermal growth factor receptor inhibitors and radiation, they designed a trial of induction chemotherapy followed by thoracic radiotherapy and concurrent erlotinib |
| Authors: | Lilenbaum R, et al |
| Title: | a phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poorrisk stage III non small cell lung cancer: results of CALGB 30605 (Alliance)/RTOG 0972 (NRG). |
| Journal: | J Thorac Oncol |
| Year: | 2015 |
| PMID: | 25384173 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | stage III non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | induction chemotherapy followed by thoracic radiotherapy + erlotinib |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with poorrisk unresectable stage III non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received two cycles of carboplatin at an AUC of 5 and nabpaclitaxel at 100 mg/m on days 1 and 8 every 21 days, followed by erlotinib administered concurrently with thoracic radiotherapy. |
| Primary End Point: | ORR, PFS, OS |
| Secondary End Point: | NA |
| Patients Number: | 78 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 67% |
| Disease Control Rate: | 93% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11 months |
| Median OS A vs. C: | 17 months |
| Adverse Event(agent arm): | NA |
| Conclusions: | Patients with poorrisk stage III non small cell lung cancer had better than expected outcomes with a regimen of induction carboplatinnabpaclitaxel followed by thoracic radiotherapy and erlotinib. Hotheyver, as per the statistical design, the 12month OS was not sufficiently high to warrant further studies. |