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RecruitingPhase 4NCT05874401

Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy

Sponsor

Pharmacosmos A/S

Enrollment

302 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small-cell Lung Cancer

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
  • Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
  • Measurable or evaluable disease as defined by RECIST v1.1

Exclusion Criteria6

  • History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
  • Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
  • Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
  • Radiotherapy within 2 weeks
  • History of ILD/pneumonitis
  • History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers

Interventions

DRUGTrilaciclib

Participants will receive intravenous trilaciclib infusion

DRUGPlacebo

Participants will receive intravenous placebo infusion

DRUGTopotecan

Participants will receive intravenous topotecan infusion

Locations(1)

Hospital

Seville, Spain

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NCT05874401

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