Clinical trial NCT04504513: 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
Overall status: APPROVED_FOR_MARKETING
Conditions: 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
Lead sponsor: G1 Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bionical Emas
First posted: 2020-08-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


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

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