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Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

Primary Purpose

Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer

Status

Approved for marketing

Phase

Locations

Study Type

Expanded Access

Intervention

Trilaciclib

About this trial

This is an expanded access trial for Myelosuppression Adult focused on measuring Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Limited Stage, Small Cell Lung Cancer Metastatic, Chemotherapy-induced Neutropenia, Chemotherapy-induced Anemia, CDK 4/6 Inhibitor, trilaciclib, etoposide, carboplatin, cisplatin, topotecan, checkpoint inhibitor, myelosuppression, cyclin-dependent kinase 4/6 inhibitor, myelopreservation, Real World Data, chemotherapy-induced myelosuppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

Patients who require treatment with either intravenous etoposide + platinum (carboplatin or cisplatin) ± an anti-PDL1 or anti-PD1 checkpoint inhibitor OR intravenous topotecan
Pathologically confirmed diagnosis of SCLC
Extensive-stage or limited-stage SCLC; patients with limited-stage SCLC receiving chemotherapy with concurrent radiation are NOT eligible.
Age ≥ 18 years
ECOG 0 to 2
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L at time of initiation of therapy in this EAP
Platelet count ≥ 100 x 10^9/L at time of initiation of therapy in this EAP
Glomerular filtration rate (GFR) of ≥ 20 mL/minute at time of initiation of therapy in this EAP
Total bilirubin ≤ 1.5x ULN (upper limit normal) at time of initiation of therapy in this EAP
AST or ALT ≤ 2.5x ULN (≤ 5x ULN in the presence of liver metastases) at time of initiation of therapy in this EAP
QTcF interval ≤ 450 msec (males) or ≤ 470 msec (females) at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF ≤ 500 msec
No personal or family history of long QT syndrome
Female patient is not lactating or currently pregnant, or plans to become pregnant, while participating in this expanded access program
Female patients of reproductive potential agree to use effective contraception while in the program and for at least 3 weeks after the last dose of trilaciclib
Patient agrees not to participate in another expanded access program or clinical trial with an experimental treatment during participation in this EAP
Active clinical trial with trilaciclib is not available (or if available, it is not appropriate) for the patient

Exclusion Criteria:

Patients requiring treatment with oral etoposide or oral topotecan
Patients outside of the United States

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04504513

First Posted

August 5, 2020

Last Updated

March 17, 2021

Sponsor

G1 Therapeutics, Inc.

Collaborators

Bionical Emas

1. Study Identification

Unique Protocol Identification Number

NCT04504513

Brief Title

Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

Official Title

Expanded Access Program: Trilaciclib for Chemotherapy-induced Myelosuppression in Patients Receiving Chemotherapy for Small Cell Lung Cancer

Study Type

Expanded Access

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Approved for marketing

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

G1 Therapeutics, Inc.

Collaborators

Bionical Emas

4. Oversight

5. Study Description

Brief Summary

The purpose of this expanded access protocol is to provide access to trilaciclib for chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for small cell lung cancer (SCLC). Patients will receive trilaciclib intravenously as a 30-minute infusion prior to chemotherapy dosing and on each day that chemotherapy is administered. Supplementary to providing access to trilaciclib, this expanded access program will also capture Real World Data to help inform subsequent trilaciclib development. Requests for access to trilaciclib will be managed by Bionical Emas. G1 Therapeutics will review eligibility of, as well as complete a medical review of, each patient access request.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer

Keywords

Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Limited Stage, Small Cell Lung Cancer Metastatic, Chemotherapy-induced Neutropenia, Chemotherapy-induced Anemia, CDK 4/6 Inhibitor, trilaciclib, etoposide, carboplatin, cisplatin, topotecan, checkpoint inhibitor, myelosuppression, cyclin-dependent kinase 4/6 inhibitor, myelopreservation, Real World Data, chemotherapy-induced myelosuppression

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Trilaciclib

Other Intervention Name(s)

G1T28

Intervention Description

Trilaciclib is a highly potent, selective, and reversible cyclin-dependent kinase 4/6 inhibitor administered intravenously prior to chemotherapy for chemotherapy-induced myelosuppression (CIM). In patients being treated for SCLC, trilaciclib transiently maintains G1 cell cycle arrest of hematopoietic stem and progenitor cells (HSPCs) in the bone marrow, thus protecting the cells from damage by cytotoxic chemotherapy (myelopreservation). This can reduce chemotherapy-related toxicity, making chemotherapy safer and more tolerable, and also reduce the need for rescue interventions that address the effects of myelosuppression, such as growth factors or blood and platelet transfusions.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: Patients who require treatment with either intravenous etoposide + platinum (carboplatin or cisplatin) ± an anti-PDL1 or anti-PD1 checkpoint inhibitor OR intravenous topotecan Pathologically confirmed diagnosis of SCLC Extensive-stage or limited-stage SCLC; patients with limited-stage SCLC receiving chemotherapy with concurrent radiation are NOT eligible. Age ≥ 18 years ECOG 0 to 2 Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L at time of initiation of therapy in this EAP Platelet count ≥ 100 x 10^9/L at time of initiation of therapy in this EAP Glomerular filtration rate (GFR) of ≥ 20 mL/minute at time of initiation of therapy in this EAP Total bilirubin ≤ 1.5x ULN (upper limit normal) at time of initiation of therapy in this EAP AST or ALT ≤ 2.5x ULN (≤ 5x ULN in the presence of liver metastases) at time of initiation of therapy in this EAP QTcF interval ≤ 450 msec (males) or ≤ 470 msec (females) at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF ≤ 500 msec No personal or family history of long QT syndrome Female patient is not lactating or currently pregnant, or plans to become pregnant, while participating in this expanded access program Female patients of reproductive potential agree to use effective contraception while in the program and for at least 3 weeks after the last dose of trilaciclib Patient agrees not to participate in another expanded access program or clinical trial with an experimental treatment during participation in this EAP Active clinical trial with trilaciclib is not available (or if available, it is not appropriate) for the patient Exclusion Criteria: Patients requiring treatment with oral etoposide or oral topotecan Patients outside of the United States

12. IPD Sharing Statement

Links:

URL

https://www.g1therapeutics.com/patients/access-to-investigational-therapies/

Description

G1 Therapeutics policy on expanded access

Learn more about this trial

Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

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