Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically...

Area of Science:

• Oncology
• Clinical Trials
• Cancer Therapeutics

Background:

• Transformed small cell lung cancer (T-SCLC) is aggressive with poor prognosis, often arising from EGFR-mutant non-small cell lung cancer (NSCLC).
• Current treatments like platinum-etoposide offer unsatisfactory progression-free survival, highlighting an unmet need for novel strategies.
• No standard treatment exists for T-SCLC, necessitating research into new therapeutic approaches.

Purpose of the Study:

• To evaluate the efficacy and safety of serplulimab combined with chemotherapy in untreated T-SCLC patients.
• To assess the potential of this combination therapy for patients with T-SCLC originating from EGFR-mutant NSCLC.
• To provide valuable insights into novel treatment strategies for this challenging cancer type.

Main Methods:

• A multicentre, open-label, single-arm phase II clinical trial (NCT05957510).
• Enrolling 36 participants with SCLC transformation from EGFR-mutant NSCLC.
• Administering serplulimab, etoposide, and carboplatin for 4-6 cycles, followed by serplulimab maintenance for up to 2 years.

Main Results:

• Enrolment began in July 2023 and is ongoing.
• The estimated completion date is December 2025.
• Primary endpoint is progression-free survival; secondary endpoints include objective response rate, overall survival, and safety.

Conclusions:

• The study aims to offer valuable data on the efficacy and safety of serplulimab plus chemotherapy for T-SCLC.
• This research addresses the urgent need for effective treatments in T-SCLC patients.
• Findings will contribute to developing improved therapeutic strategies for EGFR-mutant NSCLC transformed to SCLC.