Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Extensive Stage Small Cell Lung Cancer (SCLC)

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study is a randomized, double-blinded, placebo-controlled design. The study will include 3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be enrolled in the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G1 Therapeutics, Inc.
• Treatments: Antibodies, Monoclonal; Atezolizumab; Carboplatin; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

• Male or female subjects aged ≥18 years

• Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry

• At least 1 target lesion that is measurable by RECIST, Version 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

• Adequate organ function

Exclusion Criteria:

• Prior chemotherapy for extensive-stage SCLC

• Prior immunotherapies including but not limited to CD137, anti-PD-1, anti-PD-L1, and CTLA4.

• Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.

• History of pulmonary fibrosis, organizing pneumonia or pneumonitis on screening chest CT

• Active, known, suspected autoimmune disease requiring systemic treatment in the past 2 years

• Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure

• Known history of stroke or cerebrovascular accident within 6 months prior to enrollment

• Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol

• Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment

• Receipt of any investigational medication within 4 weeks prior to enrollment

• Administration of attenuated vaccine within 4 weeks before enrollment

• Systemic treatment with corticosteriods or other immunosuppressive medications within 14 days of study drug administration