Study on MGC018 for Patients with Relapsed or Hard-to-Treat Extensive-Stage Small-Cell Lung Cancer

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06227546

Provider View

This clinical trial is testing a new drug, MGC018, to see if it can help patients with extensive-stage small-cell lung cancer (ES-SCLC) that has returned or is not responding to treatment. The study aims to find out if MGC018 can achieve a significant response rate in these patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of MGC018 in treating patients with extensive-stage small-cell lung cancer (ES-SCLC) that has either come back or is not responding to previous treatments. Participants will receive MGC018 through an IV infusion every 28 days until the cancer progresses or side effects become too severe. Tumors will be assessed every two cycles (each cycle is 28 days). Blood samples will be collected for analysis before treatment, on the first day of the third cycle, and if the cancer progresses. A biopsy will be done before starting treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to follow the study procedures.
  • Must have advanced small cell lung cancer that cannot be treated with standard therapy. Patients with a specific type of lung cancer that has changed to small cell lung cancer can join if their cancer has worsened after chemotherapy.
  • Cancer must have worsened during or after chemotherapy.
  • Must have measurable cancer according to specific criteria.
  • Must be in good overall health with a performance status score of 0 to 2.
  • Must have adequate blood cell counts and organ function based on lab tests.
  • Must understand and agree to sign a consent form.
  • Must provide a tumor sample from a biopsy before starting treatment.
  • Women of childbearing potential must agree to use effective birth control during treatment and for six months after, and not donate eggs.
  • Men must agree to use effective birth control during treatment and for 90 days after, and not donate sperm.

Exclusion Criteria

  • Patients with treated brain metastases can join if they are stable and not on steroids for at least 7 days.
  • Cannot have a history of cancer spreading to the brain's lining.
  • Cannot be taking other experimental drugs.
  • Cannot have had major surgery within 4 weeks before starting the study or need major surgery during the study.
  • Cannot have another cancer that could interfere with the study.
  • Cannot have fluid buildup around the lungs or heart unless it is small and not causing symptoms.
  • Cannot have any other health issues that could make the study unsafe or affect the results.
  • Cannot be pregnant or breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose.

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