Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
18 Years and older, Male and Female
G1T28-05 (primary)
NCT03041311
2017-000358-20
Summary
This was 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 was a randomized, double-blinded, placebo-controlled design. Approximately, 100
patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.
Objectives
The posted results represent the final results from Study G1T28-05, a Phase 2 study of
carboplatin, etoposide, and atezolizumab with or without trilaciclib (G1T28) in patients
with untreated extensive-stage small cell lung cancer (SCLC).
The final myelopreservation efficacy results are from database lock 1 (data cut-off [DCO]
17 Aug 2018). The final anti-tumor efficacy data (BOR, DOR, PFS) are from a second
database lock 2 (DCO 28 June 2019) that occurred to support the trilaciclib New Drug
Application (NDA). Final overall survival and safety data are reported from the final
study database lock (DCO 11 Dec 2020, last patient last visit date of 29 October 2020).
Please note the last patient last visit date description above which is recorded as the
study completion date. Following the last patient last visit, the final database lock
occurred a few weeks later which accounts for the discrepancy between the study
completion date and the reported assessment time frames.
Eligibility
- 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
- Extensive-stage SCLC
- At least 1 target lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Predicted life expectancy of =3 months
- Able to understand and sign an informed consent
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