RecruitingPhase 2NCT06698965

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


Sponsor

Shanghai Chest Hospital

Enrollment

52 participants

Start Date

Oct 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two drugs — trilaciclib (a bone marrow protector) and envafolimab (an immunotherapy) — to standard chemotherapy (etoposide plus carboplatin) improves outcomes for people with extensive-stage small cell lung cancer, a fast-growing lung cancer that has spread widely. **You may be eligible if...** - You are 18 years or older - You have small cell lung cancer confirmed by biopsy - Your cancer is extensive-stage (spread beyond one lung) - You have at least one measurable tumor on imaging - You have not yet received any systemic treatment for the extensive-stage disease **You may NOT be eligible if...** - You have received prior systemic anti-tumor treatment for extensive-stage SCLC - You have significant organ dysfunction - You have uncontrolled brain metastases - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy (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.

DRUGImmunotherapy (Envafolimab)

Envafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle.

DRUGTrilaciclib

Trilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06698965


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