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

Sponsor

G1 Therapeutics, Inc. (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT04504513

Collaborator

Bionical Emas (Industry)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelosuppression Adult Chemotherapeutic Toxicity Small Cell Lung Cancer	Drug: Trilaciclib

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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