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RECRUITING
NCT06698965
PHASE2

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

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-10-13

Completion Date

2029-10-31

Last Updated

2024-11-21

Healthy Volunteers

No

Interventions

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

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China