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

NCT ID: NCT05874401

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2027-10-30

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.

Detailed Description

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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)

Group Type: EXPERIMENTAL

Trilaciclib

Intervention Type: DRUG

Participants will receive intravenous trilaciclib infusion

Topotecan

Intervention Type: DRUG

Participants will receive intravenous topotecan infusion

Placebo + Topotecan 1.5 mg/m²

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive intravenous placebo infusion

Topotecan

Intervention Type: DRUG

Participants will receive intravenous topotecan infusion

Interventions

Trilaciclib

Participants will receive intravenous trilaciclib infusion

Intervention Type: DRUG

Placebo

Participants will receive intravenous placebo infusion

Intervention Type: DRUG

Topotecan

Participants will receive intravenous topotecan infusion

Intervention Type: DRUG

Other Intervention Names

G1T28; CDK 4/6 inhibitor; cyclin-dependent kinase 4/6 inhibitor; Hycamtin

Eligibility Criteria

Inclusion Criteria

1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology

2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.

3. Measurable or evaluable disease as defined by RECIST v1.1

Exclusion Criteria

1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC

2. 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

3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids

4. Radiotherapy within 2 weeks

5. History of ILD/pneumonitis

6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacosmos A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pharmacosmos Clinical and non-clinical Department

Role: STUDY_DIRECTOR

Pharmacosmos A/S

Locations

Hospital

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Pharmacosmos Clinical and non-clinical Department

Role: CONTACT

info@pharmacosmos.com

+45 5948 5959

Facility Contacts

MD, MD

Role: primary

Other Identifiers

2022-502357-34-00

Identifier Type: OTHER

Identifier Source: secondary_id

G1T28-211

Identifier Type: -

Identifier Source: org_study_id