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Y. Nakamura
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-042 - Feasibility Study of Nivolumab and Docetaxel in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer (ID 9936)
09:30 - 09:30 | Author(s): Y. Nakamura
- Abstract
Background:
Nivolumab (NIV) is a standard second-line treatment for previously treated patients with advanced non-small cell lung cancer (NSCLC). Although there is a possibility that a higher effect can be expected by combination NIV and cytotoxic agents, verification in a clinical trial is required. Because there was only one report of phase Ib trial (N=6) of NIV + docetaxel (DTX) combination (Kanda et al, Ann Oncol 2016), we planned a feasibility study to examine the safety of this combination prior to large scale clinical trials.
Method:
Eligibility criteria included a history of platinum-based chemotherapy, PS 0-1, and adequate organ functions. Patients received NIV 3 mg/kg (days 1, 15) and DTX 60mg/m[2 ](day 1) every 4 weeks for a maximum of 2 courses. The primary endpoint was safety of 1st course and evaluated dose-limiting toxicities (DLT). This study used a 3 + 3 design and was considered to be feasible if DLT occurred in one-thirds or less of the patients. The secondary endpoints were the adverse events and the response rate. DLT was defined in accordance with the phase Ib study of Kanda et al .
Result:
Between Aug 2016 and Sep 2016, three patients were enrolled into this trial in 2 centers in Japan. First case was 57 years old female / adenocarcinoma, 2nd case was 44 years old male / squamous cell carcinoma, 3rd case was 58 years old male / adenocarcinoma. Grade 3 or more adverse events occurred only in one case of Grade 4 neutropenia, and no DLTs were observed in any cases. All patients completed 2 courses and objective tumor responses were PD, SD, PR, respectively. Two of three patients still survive more than 10 months from start of this therapy.
Conclusion:
NIV+ DTX combination therapy was acceptable for safety and further evaluation is warranted. Because the use of combination NIV plus cytotoxic agents is not approved in Japan, we are planning to conduct a phase II / III trial (CONDUCT study) comparing NIV + DTX with NIV alone in previously treated patients with advanced NSCLC in the Thoracic Oncology Research Group (TORG), using an Advanced Medical Healthcare in Japan.
