Study on Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer

Sponsor: Montefiore Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07146230

Provider View

This clinical trial is testing a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that involves a combination of immunotherapy and personalized radiotherapy. The study aims to determine if this approach is safe and effective for patients with a high PD-L1 tumor score.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment for locally advanced non-small cell lung cancer (NSCLC) that combines two immunotherapy drugs with personalized radiotherapy. The study focuses on patients whose tumors have a high level of PD-L1, a protein that can affect how the immune system responds to cancer. Participants will receive two different combinations of immunotherapy drugs, either durvalumab with monalizumab or durvalumab with oleclumab, followed by personalized radiotherapy and additional immunotherapy cycles.

Description

Lung cancer is a leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) being the most common type. This study is exploring a new treatment for patients with locally advanced NSCLC, which includes stage III and some stage II cancers that cannot be removed by surgery. Traditionally, these patients receive chemotherapy and radiotherapy, but this can cause side effects and may not be effective for everyone.

This trial is testing a new approach that uses immunotherapy drugs, which help the immune system fight cancer, in combination with personalized radiotherapy. The study will compare two different immunotherapy combinations: durvalumab with monalizumab and durvalumab with oleclumab. These drugs work by blocking proteins that can stop the immune system from attacking cancer cells.

Participants will receive two cycles of immunotherapy, followed by a four-week course of radiotherapy tailored to their specific needs, and then up to ten more cycles of immunotherapy. The goal is to see if this approach can improve treatment outcomes and reduce side effects compared to traditional methods.

The study will include regular evaluations, such as imaging scans and lab tests, to monitor the cancer's response to treatment and ensure the safety of participants. Researchers hope that this personalized approach will lead to better control of the cancer and improve survival rates for patients with high PD-L1 expression.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent and willing to follow study requirements.
  • Age over 18 years and body weight of at least 35 kg.
  • Life expectancy of at least 12 weeks.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Diagnosed with untreated, locally advanced NSCLC, including certain stage II and III cases.
  • High PD-L1 tumor score of at least 50%.
  • Recent imaging showing at least one active lung lesion or lymph node.
  • Adequate organ and bone marrow function based on specific lab tests.

Exclusion Criteria

  • Participation in another clinical trial with an investigational product in the last 3 months.
  • Unresolved side effects from previous cancer treatments, except for certain conditions.
  • Current or recent use of other cancer treatments, except for specific non-cancer therapies.
  • History of another primary cancer, except for certain treated cases.
  • Certain autoimmune or inflammatory disorders, unless well-controlled.
  • Uncontrolled health conditions that could interfere with the study.
  • Recent history of severe edema or blood clots.
  • Significant heart or vascular disease.
  • Active infections, including hepatitis or HIV.
  • Recent use of immunosuppressive medications, except for specific cases.
  • Recent receipt of live vaccines.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Known allergies to study drugs.
  • Previous treatment with similar immunotherapy drugs, unless specific conditions are met.

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