NCT06698965

Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

A Randomized, Controlled Phase II Clinical Study on the Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, controlled phase II study aims to evaluate the efficacy of combination therapy with Envafolimab and chemotherapy in first-line extensive stage SCLC, as well as the impact of Trilaciclib on the incidence of myelosuppression and anti-tumor effects in patients.

Conditions

• Lung Cancer, Small Cell

Interventions

Type	Name	Description
DRUG	Chemotherapy （Etoposide and Carboplatin）	Etoposide: 80-100mg/m2, Q3W, intravenous infusion is administered on day 1, 2 and 3 of each cycle. Carboplatin: AUC=5, Q3W, intravenous infusion is administered on day 1 of each cycle.
DRUG	Immunotherapy （Envafolimab）	Envafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle.
DRUG	Trilaciclib	Trilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy

Timeline

• Start date: 2024-10-13
• Primary completion: 2029-10-31
• Completion: 2029-10-31
• First posted: 2024-11-21
• Last updated: 2024-11-21

Locations

1 site across 1 country: China