| General information |
| Database: | DB00793 |
| Objective: | they conducted a phase II study of docetaxel in combination with everolimus, a mammalian target of rapamycin (mTOR) inhibitor, for salvage therapy of advanced non small cell lung cancer (non small cell lung cancer) based on promising preclinical and earlyphase clinical data |
| Authors: | Ramalingam SS, et al |
| Title: | Phase II study of docetaxel in combination with everolimus for second or thirdline therapy of advanced non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2013 |
| PMID: | 23407561 |
| Trial Design |
| Clinical Trial Id: | NCT00401778 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | docetaxel + everolimus |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with advancedstage non small cell lung cancer treated with one or two previous systemic therapy regimens |
| Biomarker: | Archived tumor specimens were evaluated for markers of mTOR pathway activation (total and phosphorylated mTOR, Akt, S6, eIF4e, and 4EBP1). |
| Biomark Analysis: | Low pAkt expression correlated with clinical benefit rate (p = 0.01) but not with progression free survival or overall survival. |
| Control Group Info: | single arm |
| Treatment Info: | patients were given docetaxel (60 mg/m) and everolimus (5 mg orally once daily on days 119) every 3 weeks. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 28 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 8% |
| Disease Control Rate: | 71% |
| Median Time to Progression: | 4.42 months |
| Median PFS A vs. C: | The 6month progression free survival rate was 5% |
| Median OS A vs. C: | 9.6 months |
| Adverse Event(agent arm): | Neutropenia, anorexia, fatigue, and hyperlipidemia were the most frequently reported toxicities |
| Conclusions: | The combination of everolimus and docetaxel was tolerated well, but the efficacy was relatively modest in an unselected population of patients with non small cell lung cancer. |