Turtle Study: A Phase 2 Study of Durvalumab Plus Carboplatin and Etoposide in Elderly Patients With Extensive-Stage SCLC (LOGiK 2003).

INTRODUCTION

The combination of immune checkpoint inhibitors with chemotherapy is the standard treatment for extensive-stage (ES) SCLC. However, its safety for elderly patients is not fully validated. We evaluated the safety and efficacy of durvalumab plus carboplatin and etoposide in elderly patients with ES-SCLC.

METHODS

In this prospective, single-arm, multicenter, phase 2 clinical trial, patients with ES-SCLC aged above or equal to 75 years received chemotherapy with up to four cycles of durvalumab 1500 mg on day 1, carboplatin at a dose equivalent to an area under the curve of 5 on day 1, and etoposide 80 mg/m on days 1 to 3 every 3 weeks as induction therapy. Maintenance therapy with durvalumab 1500 mg was administered every 4 weeks until disease progression or unacceptable toxicity. The primary end point was safety, and key secondary end points were objective response rate, progression-free survival, overall survival, quality of life, and Geriatric Assessment.

RESULTS

Between August 2021 and February 2023, 40 patients were enrolled at 17 institutions and 38 were assessable for safety and efficacy. Grade 3 or higher adverse events occurred in 36 patients (94.6%). The most common adverse events were hematologic, including grade 3 or higher neutropenia (76.3%) and febrile neutropenia (15.8%). The objective response rate, median progression-free survival, and median overall survival were 89.5%, 5.4 months, and 16.1 months, respectively. No decrease in quality of life or functional assessment scores was observed after treatment.

CONCLUSION

Durvalumab plus carboplatin and etoposide was tolerable and expected to be effective in elderly patients with ES-SCLC.