Status:
APPROVED_FOR_MARKETING
Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer
Lead Sponsor:
G1 Therapeutics, Inc.
Collaborating Sponsors:
Bionical Emas
Conditions:
Myelosuppression Adult
Chemotherapeutic Toxicity
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients requiring treatment with oral etoposide or oral topotecan
- Patients outside of the United States
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04504513
Last Update
March 19 2021
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