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Type(s) of Cancer
Lung
Study Phase
Phase 2B
Study Completion Date
2018-08-17
NCT03041311Uploaded 11-05-2020
Available for Download
PDS UID: LungSm_G1Thera_2017_435
Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)
Provider Information
Provider Data DescriptionPrimary: Evaluate potential of trilaciclib, compared with placebo, to reduce chemotherapy-induced myelosuppression in patients with SCLC undergoing treatment with etoposide, carboplatin, and atezolizumab (E/P/A) Key Secondary: Evaluate potential of trilaciclib, compared with placebo, to reduce chemotherapy-induced myelosuppression and its consequences in patients with SCLC undergoing treatment with E/P/A *** A complete list can be found in the NCT listing;
SponsorG1 Therapeutics, Inc.
Data ProviderG1 Therapeutics, Inc.
Partial set or SubsetOriginal Data
Patients in dataset107
# of Patients Control53
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/54pc-ep24
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: Trilaciclib
Drug: Placebo
Drug: Carboplatin
Drug: Etoposide
Drug: Atezolizumab
Drug(s)Drug: Trilaciclib
Drug: Carboplatin
Drug: Etoposide
Drug: Atezolizumab
Drug: Placebo
Total Enrolled107
RandomizationRandomized
Blinding MethodDouble
Arms Interventiontrilaciclib+etoposide/carboplatin/atezolizumab - Experimental
placebo+etoposide/carboplatin/atezolizumab - Experimental
Secondary ID2017-000358-20
PubMed (PMID)33348420
33895103
34873975
34777341
34408488
34405547
Collaborator(s)Roche-Genentech
Region(s)United States
Bulgaria
Estonia
France
Latvia
Spain
Ukraine
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLNot Provided
CRFNot Provided
DATA DICTIONARYData descriptors for SCLC 03.xlsx
DATA SUMMARYDescriptive_Stats_G1T_NCT03041311.xlsx
DATA SUMMARYProc Contents Data Dictionary G1T_NCT03041311.pdf
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DATA (COMPARATOR ARM)adlb.sas7bdat
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