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

NCT06698965 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-11-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-13
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698965 on ClinicalTrials.gov