Study on the Effectiveness and Safety of Olvimulogene Nanivacirepvec with Chemotherapy and Immune Therapy Compared to Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Genelux Corporation

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06463665

Provider View

This clinical trial is testing a new treatment using a virus-based therapy called Olvi-Vec, combined with chemotherapy and an immune therapy of the doctor's choice, to see if it works better than the standard drug docetaxel for patients with advanced non-small cell lung cancer (NSCLC) that has progressed after initial treatment.

Patient Parameters

Program Overview

This Phase 2 study is open to patients with advanced non-small cell lung cancer (NSCLC) to evaluate the effectiveness and safety of a new treatment. The treatment involves an oncolytic virus called Olvi-Vec, given through an IV, followed by chemotherapy and an immune therapy chosen by the doctor. This will be compared to the standard treatment with the drug docetaxel. The study is for patients whose cancer has progressed after initial treatment with chemotherapy and immune therapy.

Description

Olvi-Vec is a type of virus-based therapy that targets and kills cancer cells. It has shown promise in laboratory studies for treating non-small cell lung cancer (NSCLC). This study aims to test if Olvi-Vec, followed by chemotherapy and an immune therapy, can effectively treat advanced NSCLC. Patients eligible for this study will have advanced or metastatic NSCLC without specific genetic changes in certain cancer-related genes. They must have experienced cancer progression after initial treatment with chemotherapy and immune therapy. The study will compare the new treatment to the standard drug docetaxel. Patients will be divided into groups based on how long they were on immune therapy before their cancer progressed. The study will start with three initial groups to determine the best dose and schedule for Olvi-Vec. After this, patients will be randomly assigned to receive either the new treatment or docetaxel. If the cancer progresses on docetaxel, patients may switch to the new treatment if eligible.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC).
  • Have received 2 to 6 cycles of initial chemotherapy with immune therapy, regardless of specific protein expression levels.
  • Have experienced cancer progression after initial or maintenance immune therapy.
  • Have at least one measurable tumor outside the brain.
  • Have adequate kidney, liver, and bone marrow function, as well as normal blood clotting and immune function.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Be willing to attend scheduled visits and follow the treatment plan, including tests and scans.

Exclusion Criteria

  • Have an active and untreated infection like a urinary tract infection or pneumonia.
  • Have untreated cancer that has spread to the brain.
  • Have any uncontrolled medical condition that could interfere with the study.
  • Have severe side effects from previous cancer treatments, except for hair loss or skin color changes.
  • Require additional immune-suppressing medications or high doses of steroids.
  • Are taking antiviral medications that work against the vaccinia virus.
  • Have had major surgery within the last 4 weeks or are not fully recovered from surgery.
  • Have received previous virus-based gene therapy or treatments with a virus.
  • Have been vaccinated against smallpox or monkeypox within the last year.
  • Have received any non-cancer vaccines within 2 weeks of starting the study.
  • Have significant skin conditions like severe eczema or psoriasis.
  • Are allergic to any of the study drugs or their components.
  • Have had severe allergic reactions to immune therapy in the past.
  • Have mental health conditions that prevent understanding the study or following its requirements.

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