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Lung (Small Cell)

Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive Stage Small Cell Lung Cancer

Unique Dataset IDLungSm_G1Thera_2017_435ClinicalTrial.gov IDNCT03041311
DownloadableYes
SponsorG1 Therapeutics, Inc.Data ProviderG1 Therapeutics, Inc.Total Study Enrolled Patients107Comparator (Control) Arm Enrolled Patients53RandomizationYes
Study PhaseClinical Study Phase IIBBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyDataset TypeADS

Clinical Trial Title

Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive Stage Small Cell Lung Cancer

Trial Summary and Conditions

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.

Data Summary

Control arm data on demographics, safety, efficacy (ORR, PFS, OS), treatment exposure, concomitant medications, medical history, ECOG performance status, prior/concomitant procedures, and labs

Study Objectives

Primary: 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;

Outcome Measures

Primary: Duration of Severe (Grade 4) Neutropenia in Cycle 1; Occurrence of Severe (Grade 4) Neutropenia Key Secondary: Overall survival; All-cause dose reductions; Occurrence of RBC transfusions on/after Week 5 ; Occurrence of G-CSF administration; Major Adverse Hematologic Events (MAHE) and Components *** A complete list can be found in the NCT listing;

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Dummy.txt

CRF: Blank.txt

DATA DICTIONARY: Data descriptors for SCLC 03.xlsx

DATA SUMMARY: Descriptive_Stats_G1T_NCT03041311.xlsx

DATA SUMMARY: Proc Contents Data Dictionary G1T_NCT03041311.pdf

DATA (COMPARATOR ARM): addv.sas7bdat

DATA (COMPARATOR ARM): adecog.sas7bdat

DATA (COMPARATOR ARM): adeg.sas7bdat

DATA (COMPARATOR ARM): adex.sas7bdat

DATA (COMPARATOR ARM): admh.sas7bdat

DATA (COMPARATOR ARM): adae.sas7bdat

DATA (COMPARATOR ARM): adpr.sas7bdat

DATA (COMPARATOR ARM): adsl.sas7bdat

DATA (COMPARATOR ARM): adcm.sas7bdat

DATA (COMPARATOR ARM): adtr2.sas7bdat

DATA (COMPARATOR ARM): adtte.sas7bdat

DATA (COMPARATOR ARM): adrs.sas7bdat

DATA (COMPARATOR ARM): adex2.sas7bdat

DATA (COMPARATOR ARM): adtr.sas7bdat

DATA (COMPARATOR ARM): advs.sas7bdat

DATA (COMPARATOR ARM): adlb.sas7bdat