Study of NC318 Alone or with Pembrolizumab for Advanced Non-Small Cell Lung Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04699123

Provider View

This clinical trial is exploring the effects of a new drug, NC318, alone or combined with Pembrolizumab, in patients with advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of NC318, a new drug, either by itself or in combination with Pembrolizumab, in treating patients with advanced non-small cell lung cancer (NSCLC). The study is divided into different groups based on previous treatments and specific characteristics of the cancer.

Description

This study involves several groups of patients with advanced non-small cell lung cancer (NSCLC):

  • Group 1a and 1b: These patients have advanced NSCLC and have already tried treatments that target the PD-1 pathway but their cancer has continued to grow. Patients in Group 1a will receive NC318 alone, while those in Group 1b will receive NC318 combined with Pembrolizumab. The study will first test the safety of these treatments with a small group of patients. If safe, more patients will be added to see how well the treatments work.

  • Group 2: This group includes patients with advanced NSCLC who have not yet received PD-1 pathway treatments and have a specific marker (PD-L1) less than 50%. They will receive the combination of NC318 and Pembrolizumab. Like the other groups, the study will start with a safety check before enrolling more patients.

The study was updated in May 2023 to include additional groups (1c and 2a) that will receive NC318 at a specific dose schedule. Patients in Group 1a may switch to the combination treatment if their cancer progresses, after a required tumor biopsy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or has spread.
  • Be in good overall health, able to carry out daily activities with little or no assistance.
  • Have measurable cancer that can be tracked during the study.
  • For Groups 1a, 1b, and 1c: Have previously received PD-1 pathway treatments and have documented cancer growth.
  • For Group 2a: Have not received PD-1 pathway treatments and have a PD-L1 marker less than 50%.
  • If the cancer has specific genetic changes (ALK, ROS1, EGFR, BRAF), must have tried and not responded to specific targeted treatments.
  • Have a tumor that can be biopsied and agree to provide a sample before starting the study and if the cancer progresses.
  • Have adequate blood counts and organ function.

Exclusion Criteria

  • Have had severe side effects from previous PD-1 pathway treatments that could be life-threatening.
  • Have untreated or symptomatic cancer that has spread to the brain or spinal cord. Patients with treated, stable brain metastases may be eligible if they meet specific conditions.
  • Have a history of cancer spreading to the membranes around the brain and spinal cord.
  • Have received radiation therapy outside the brain or spinal cord within two weeks before starting the study.
  • Are taking medications that suppress the immune system within two weeks before starting the study, except for certain allowed medications.
  • For Group 2a: Have not received any PD-1 pathway treatments before.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.