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NCT Number: NCT05874401

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

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.

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Key information

Conditions

Extensive-stage Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital

Seville, Spain

Location status: Recruiting

Location contact

MD, MD

CONTACT

About this study

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.

Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Trilaciclib

Drug

Participants will receive intravenous trilaciclib infusion

Other names: G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor

Placebo

Drug

Participants will receive intravenous placebo infusion

Topotecan

Drug

Participants will receive intravenous topotecan infusion

Other names: Hycamtin

Primary outcomes

  1. Overall survival (OS)

    Time frame: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months

    To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan

Secondary outcomes

  1. Anti-tumor efficacy

    Time frame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months

    To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan

  2. Anti-tumor efficacy

    Time frame: From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months

    To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan

  3. Anti-tumor efficacy

    Time frame: From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months

    To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan

  4. Neutrophil-related myeloprotection efficacy

    Time frame: From date of randomization until end of cycle 1 (each cycle is 21 days)

    Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1

  5. Neutrophil-related myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs

  6. Neutrophil-related myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Occurrence of G-CSF administration

  7. RBC related myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration

  8. RBC related myeloprotection efficacy

    Time frame: From date of randomization until end of Week 5

    RBC transfusions on or after Week 5 (occurrence)

  9. RBC related myeloprotection efficacy

    Time frame: From date of randomization until end of Week 5

    RBC transfusions on or after Week 5 (number of transfusions)

  10. Platelet related myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence)

  11. Platelet related myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions)

  12. Myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Occurrence of hospitalizations due to chemotherapy-induced myelosuppression

  13. Myeloprotection efficacy

    Time frame: From date of randomization until end of treatment, assessed up to 52 months

    Number of hospitalizations due to chemotherapy-induced myelosuppression

  14. Chemotherapy dosing

    Time frame: From the date of randomization until end of treatment, assessed up to 52 months

    To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan.

  15. Chemotherapy dosing

    Time frame: From the date of randomization until end of treatment, assessed up to 52 months

    To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan.

  16. Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE

    Time frame: From the date of randomization until end of treatment, assessed up to 52 months

    To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest

Study contacts

Contact information is provided by the study sponsor or research team.

Pharmacosmos Clinical and non-clinical Department

CONTACT

[email protected]

+45 5948 5959

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 24, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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