Access to Trilaciclib for Patients Undergoing Chemotherapy for Small Cell Lung Cancer

Sponsor: G1 Therapeutics, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04504513

Provider View

This program provides access to the drug trilaciclib for patients with small cell lung cancer (SCLC) who are receiving chemotherapy. Trilaciclib is given to help manage side effects from chemotherapy. The program also collects data to support future development of the drug.

Patient Parameters

Program Overview

This program allows patients with small cell lung cancer (SCLC) who are receiving chemotherapy to access trilaciclib, a drug that helps manage side effects caused by chemotherapy. Trilaciclib is given through an IV for 30 minutes before each chemotherapy session. The program also gathers real-world data to aid in the development of trilaciclib. Requests for the drug are handled by Bionical Emas, and G1 Therapeutics reviews each patient's eligibility.

Eligibility Criteria

Inclusion Criteria

  • Must need treatment with specific chemotherapy drugs, such as etoposide with platinum (carboplatin or cisplatin) or topotecan, possibly with additional cancer drugs.
  • Must have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Can have either extensive-stage or limited-stage SCLC, but not if receiving chemotherapy with radiation for limited-stage SCLC.
  • Must be 18 years or older.
  • Must be in relatively good health with an ECOG performance status of 0 to 2.
  • Must have certain blood counts and organ functions within specified limits.
  • Must not have a personal or family history of long QT syndrome.
  • Female patients must not be pregnant or breastfeeding and must agree to use contraception during the program and for three weeks after the last dose.
  • Must not be participating in another experimental treatment program or trial.
  • No active clinical trial with trilaciclib is available or suitable for the patient.

Exclusion Criteria

  • Cannot be receiving oral forms of etoposide or topotecan.
  • Must be located within the United States.

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