| General information |
| Database: | DB00770 |
| Objective: | Thisphase III study examined efficacy of the synthetic Tolllike receptor 9activating oligodeoxynucleotide PF3512676 in combination with standard paclitaxel/carboplatin chemotherapy in patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Hirsh V, et al |
| Title: | Randomizedphase III trial of paclitaxel/carboplatin with or without PF3512676 (Tolllike receptor 9 agonist) as firstline treatment for advanced non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 21632509 |
| Trial Design |
| Clinical Trial Id: | NCT00254891 |
| Agent: | PF3512676
|
| Target: | tolllike receptor
|
| 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: | paclitaxel/carboplatin with PF3512676 (Tolllike receptor 9 agonist |
| Study Type: | Randomizedphase III trial |
| Key Patients Feature: | Chemotherapynaive patients with stage IIIB or IV non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | paclitaxel/carboplatin with or without PF3512676 (Tolllike receptor 9 agonist |
| Treatment Info: | patients were randomly assigned (1:1) to receive up to six courses of paclitaxel/carboplatin (intravenous paclitaxel 200 mg/m(2) and carboplatin at area under the [concentrationtime] curve 6 on day 1 of a 3week cycle) alone (control arm) or in combination with 0.2 mg/kg subcutaneous PF3512676 on days 8 and 15 (investigational arm). |
| Primary End Point: | overall survival (OS) |
| Secondary End Point: | NA |
| Patients Number: | 828 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | the investigational arm compared with the control arm (28% v 23%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | investigational arm, 4.8 months v control arm, 4.7 months; P = .79 |
| Median OS A vs. C: | investigational arm, 10.0 months v control arm, 9.8 months; P = .56 |
| Adverse Event(agent arm): | The most common treatmentemergent, allcausality hematologic AEs were neutropenia, anemia, and thrombocytopenia |
| Conclusions: | Addition of PF3512676 to paclitaxelcarboplatin did not improve OS or PFS versus paclitaxelcarboplatin alone for firstline treatment of patients with advanced non small cell lung cancer but did increase toxicity. This regimen cannot be recommended for treating patients with advanced non small cell lung cancer. |