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

• Status: Not yet recruiting
• Trial end date: 2027-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G1 Therapeutics, Inc.
• Treatments: Topotecan

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