A Phase II Study of Rovalpituzumab Tesirine for Recurrent Small Cell Lung Cancer: the TRINITY Study

Full Title

An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects with Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)(SCRX001-002)

Purpose

There is no standard "third-line" therapy for people with small cell lung cancer that has continued to grow despite two prior regimens of therapy. In this study, researchers are evaluating third-line therapy with the investigational drug rovalpituzumab tesirine in patients with recurrent small cell lung cancer.

Rovalpituzumab tesirine is an "antibody-drug conjugate." This means it contains an antibody that binds to a receptor on cancer cells (in this case, a protein called DLL3), and then enters and kills the cancer cells. Rovalpituzumab tesirine is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have small cell lung cancer that came back or continued to grow despite at least two prior regimens of therapy.
  • Patients' lung cancers must be positive for the DLL3 protein.
  • At least 4 weeks must pass since completion of any prior immunotherapies and 2 weeks since other treatments and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Charles Rudin at 646-888-4336.

Protocol

16-270

Phase

II

Investigator

Co-Investigators

Locations