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Type(s) of Cancer
Lung (Small Cell)
Study Phase
Phase 2B
Study Completion Date
July 2018
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
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 SubsetN/A
Patients in dataset107
# of Patients Control53
# of Patients Experimental53
DOIhttps://doi.org/10.34949/54pc-ep24
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis 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.
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 Enrolled105
RandomizationRandomized
Blinding MethodDouble
Arms Interventiontrilaciclib+etoposide/carboplatin/atezolizumab - Experimental
placebo+etoposide/carboplatin/atezolizumab - Experimental
Secondary ID2017-000358-20
PubMed (PMID)NA
Collaborator(s)NA
Region(s)United States
Bulgaria
Estonia
France
Latvia
Spain
Ukraine
Age RangeMinimum Age: 18 Years
Maximum Age: N/A
Files:
PROTOCOLDummy.txt
CRFBlank.txt
DATA DICTIONARYData descriptors for SCLC 03.xlsx
DATA SUMMARYDescriptive_Stats_G1T_NCT03041311.xlsx
DATA SUMMARYProc Contents Data Dictionary G1T_NCT03041311.pdf
DATA (COMPARATOR ARM)addv.sas7bdat
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DATA (COMPARATOR ARM)adsl.sas7bdat
DATA (COMPARATOR ARM)adcm.sas7bdat
DATA (COMPARATOR ARM)adtr2.sas7bdat
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DATA (COMPARATOR ARM)adrs.sas7bdat
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DATA (COMPARATOR ARM)adtr.sas7bdat
DATA (COMPARATOR ARM)advs.sas7bdat
DATA (COMPARATOR ARM)adlb.sas7bdat
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