Combining Trilaciclib with Lurbinectedin for Small-cell Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of Trilaciclib on reducing myelosuppression in patients with extensive stage small-cell lung cancer (SCLC) who are receiving Lurbinectedin after failing platinum-based chemotherapy. The trial aims to improve the safety and tolerability of Lurbinectedin by mitigating its side effects, particularly myelosuppression, which is a common and serious complication. Participants will be closely monitored for their response to treatment and any adverse effects. The study is designed for patients who have previously been treated with platinum agents and PD1 or PDL1 inhibitors.

Why it matters

Who can join: the full rules

In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Age ≥ 18 years at the time of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Measurable disease according to RECIST v1.1 within 28 days prior to start of treatment.
* Previous treatment with a platinum agent, PD1 or PDL1 agent.

Exclusion Criteria:

* Active infection requiring systemic therapy.

  * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  * Treatment with any investigational drug within 4 weeks prior to start of treatment.
  * A known allergy or sensitivity to either study drug or its excipients.
  * Subject is receiving prohibited medications or treatments as listed in the protocol.

Where it's running

• Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Dartmouth Hitchcock Medical Center
  Lebanon, New Hampshire, United States Withdrawn

Study contacts

• Principal investigator: Jared Weiss, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Shamina Williams
• Email: shamina_williams@med.unc.edu
• Phone: 919-966-4432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.