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

G1 Therapeutics

Status and phase: Enrolling; Phase 4

Conditions: Extensive-stage Small-cell Lung Cancer

Treatments: Drug: Topotecan; Drug: Trilaciclib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05874401

G1T28-211

2022-502357-34-00 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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)

Treatment:

Drug: Trilaciclib

Drug: Topotecan

Placebo + Topotecan 1.5 mg/m²

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo

Drug: Topotecan