Study on Photoimmunotherapy with ASP-1929 and Cemiplimab for Treating Advanced Non-Small Cell Lung Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06943664

Provider View

This clinical trial is exploring a new treatment that combines light-activated drugs with immunotherapy to target and kill cancer cells in patients with advanced non-small cell lung cancer (NSCLC) that cannot be operated on or has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to test how well a new treatment called photoimmunotherapy (PIT) works in patients with advanced non-small cell lung cancer (NSCLC) that hasn't responded to previous treatments, can't be removed by surgery, or has spread to other areas. PIT uses a drug called ASP-1929, which becomes active when exposed to light, combined with an immunotherapy drug called cemiplimab. ASP-1929 includes a component that binds to a protein on tumor cells, potentially stopping them from growing. When activated by a special laser light, it helps destroy tumor cells. Cemiplimab helps the immune system attack the cancer. This combination may be more effective in killing cancer cells in patients with advanced NSCLC.

Description

The main goal of this study is to see how well the combination of photoimmunotherapy and cemiplimab works in shrinking tumors and lymph nodes in patients with advanced non-small cell lung cancer (NSCLC). Researchers will also look at how long patients live after receiving this treatment and how long they remain free from cancer progression. The study will evaluate the safety of the treatment and explore how changes in certain tumor markers relate to the treatment's effectiveness.

Participants will receive cemiplimab through an IV on specific days of each treatment cycle and ASP-1929 through an IV on another day. They will undergo a procedure where a special light is used to activate the treatment in the tumor. This process is repeated every 9 weeks for up to 2 years, as long as the cancer does not progress and side effects are manageable. Throughout the study, participants will have regular blood tests and imaging scans to monitor their health and the treatment's impact. After completing the treatment, participants will have follow-up visits every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of stage IIIB-IV non-small cell lung cancer (NSCLC).
  • Have previously received certain treatments for NSCLC and have not responded or have progressed after treatment.
  • Have at least two measurable tumors.
  • Have at least one tumor that can be treated with photoimmunotherapy.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose.
  • Must understand the study and sign a consent form before participating.

Exclusion Criteria

  • Have received an investigational drug within 30 days before starting the study.
  • Have had major surgery within 4 weeks before starting the study.
  • Have received chemotherapy or chemoimmunotherapy within 21 days before starting the study.
  • Have received high-dose or curative radiotherapy to the target tumors within 30 days before starting the study.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of severe immune-related side effects from previous treatments.
  • Have a history of organ or stem cell transplantation.
  • Have significant heart problems or abnormal heart rhythms.
  • Have active bleeding disorders or require blood thinners that cannot be adjusted.
  • Have untreated or unstable brain metastases.
  • Have a history of hepatitis B, hepatitis C, or HIV, unless under control.
  • Have active autoimmune disorders requiring systemic treatment.
  • Have significant lung disease or active pneumonitis.
  • Have uncontrolled illnesses or psychiatric conditions that would interfere with the study.
  • Are pregnant or breastfeeding.
  • Are unwilling or unable to follow the study requirements.

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