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

This study is currently recruiting participants.
Verified September 2017 by G1 Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03041311
First Posted: February 2, 2017
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
G1 Therapeutics, Inc.
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer Drug: Trilaciclib Drug: Placebo Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by G1 Therapeutics, Inc.:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 36 Months ]
  • Treatment related adverse events (AE) based on NCI CTCAE v4.0 [ Time Frame: 24 Months ]

Secondary Outcome Measures:
  • Number of patients with objective response (CR or PR) based on RECIST v1.1 [ Time Frame: 36 Months ]
  • PFS based on RECIST v1.1 [ Time Frame: 36 Months ]
  • Abnormal Laboratory Events [ Time Frame: 24 Months ]
    Incidence of Grade 3 and 4 abnormalities in safety-related laboratory parameters

  • Incidence of of immune-related adverse events (irAEs) [ Time Frame: 24 Months ]

Estimated Enrollment: 100
Actual Study Start Date: April 7, 2017
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trilaciclib+etoposide/carboplatin/atezolizumab

Induction: Patients will receive trilaciclib 240 mg/m2 administered IV once daily on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m2 will be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin will be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg will be administered as an IV on Day 1 of each 21-day cycle.

Maintenance: Following the induction phase, patients will receive maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, withdrawal of consent, death, or study termination by the Sponsor.

Drug: Trilaciclib
Trilaciclib IV
Other Name: G1T28
Drug: Carboplatin
Carboplatin IV
Other Name: Paraplatin
Drug: Etoposide
Etoposide IV
Other Name: VP-16
Drug: Atezolizumab
Atezolizumab IV
Other Name: Tecentriq
Experimental: placebo+etoposide/carboplatin/atezolizumab

Induction: Patients will receive placebo administered IV once daily on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m2 will be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin will be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg will be administered as an IV on Day 1 of each 21-day cycle.

Maintenance: Following the induction phase, patients will receive maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, withdrawal of consent, death, or study termination by the Sponsor.

Drug: Placebo
Placebo IV
Drug: Carboplatin
Carboplatin IV
Other Name: Paraplatin
Drug: Etoposide
Etoposide IV
Other Name: VP-16
Drug: Atezolizumab
Atezolizumab IV
Other Name: Tecentriq

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041311


Contacts
Contact: G1Therapeutics Clinical Contact 1-855-418-7425 clinicalinfo@g1therapeutics.com

  Show 42 Study Locations
Sponsors and Collaborators
G1 Therapeutics, Inc.
Investigators
Study Director: Clinical Contact G1 Therapeutics, Inc.
  More Information

Responsible Party: G1 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03041311     History of Changes
Other Study ID Numbers: G1T28-05
2017-000358-20 ( EudraCT Number )
First Submitted: February 1, 2017
First Posted: February 2, 2017
Last Update Posted: October 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by G1 Therapeutics, Inc.:
Small Cell Lung Cancer
CDK 4/6 Inhibitor
Immune Checkpoint Inhibitor

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Atezolizumab
Carboplatin
Etoposide
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs