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

NCT05874401 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: G1T28-2112022-502357-34-00
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive-stage Small-cell Lung Cancer

Keywords

myelosuppression; ES-SCLC; chemotherapy-induced myelosuppression; chemotherapy-induced neutropenia; chemotherapy-induced anemia; myeloprotection

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

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

  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

Secondary Outcomes (16)

• Anti-tumor efficacy

  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

• Anti-tumor efficacy

  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

• Anti-tumor efficacy

  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

• Neutrophil-related myeloprotection efficacy

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

• Neutrophil-related myeloprotection efficacy

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

Study Arms (2)

Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²

EXPERIMENTAL

Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)

Drug: Trilaciclib; Drug: Topotecan

Placebo + Topotecan 1.5 mg/m²

PLACEBO COMPARATOR

Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).

Drug: Placebo; Drug: Topotecan

Interventions

Trilaciclib DRUG

Participants will receive intravenous trilaciclib infusion

Also known as: G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor

Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²

Placebo DRUG

Participants will receive intravenous placebo infusion

Placebo + Topotecan 1.5 mg/m²

Topotecan DRUG

Participants will receive intravenous topotecan infusion

Also known as: Hycamtin

Placebo + Topotecan 1.5 mg/m²; Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Hospital

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

trilaciclib; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Pharmacosmos Clinical and non-clinical Department

  Pharmacosmos A/S

  STUDY DIRECTOR

Central Study Contacts

Pharmacosmos Clinical and non-clinical Department

CONTACT

+45 5948 5959; info@pharmacosmos.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 24, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)