Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer (NCT04504513) | Clinical Trial Compass
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Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.