Study on Durvalumab and Tremelimumab with Chemotherapy for Virus-Infected Patients with Advanced Non-Small Cell Lung Cancer

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04499053

Provider View

This clinical trial is testing a combination of two immunotherapy drugs, durvalumab and tremelimumab, with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who are also infected with HIV, hepatitis B, or hepatitis C.

Patient Parameters

Program Overview

The study aims to find out if combining the immunotherapy drugs durvalumab and tremelimumab with standard chemotherapy is safe and effective for treating stage IV non-small cell lung cancer (NSCLC) in patients who also have HIV, hepatitis B, or hepatitis C. Participants will receive chemotherapy and durvalumab for four cycles, followed by maintenance therapy with durvalumab, with or without another drug called pemetrexed, depending on the type of NSCLC.

Description

This study is open to patients with stage IV non-small cell lung cancer (NSCLC) who are also infected with HIV, hepatitis B, or hepatitis C. The trial will test the safety and effectiveness of combining two immunotherapy drugs, durvalumab and tremelimumab, with standard chemotherapy. Participants will receive four cycles of treatment with these drugs every three weeks. After the initial treatment, those who respond well will continue with maintenance therapy using durvalumab, and possibly pemetrexed for certain types of NSCLC.

The study will enroll patients in two groups: one for those with HIV and another for those with hepatitis B or C. The trial will use a two-stage design to determine if the treatment is effective. If the first few patients in a group respond well, more patients will be enrolled. The study will monitor the safety of the treatment by checking for any severe side effects during the first 42 days.

Participants will receive chemotherapy drugs based on their type of NSCLC. The study will also evaluate the response to treatment using specific criteria and monitor any side effects using standard guidelines. The goal is to see if this combination of drugs can help control the cancer in patients with these viral infections.

Eligibility Criteria

Inclusion Criteria

  • Have stage IV non-small cell lung cancer (NSCLC) and have not received previous treatment for this stage.
  • For HIV-positive patients: Must be on effective anti-retroviral therapy for at least 4 weeks, with a viral load under 400 copies/mL, no recent opportunistic infections, and no incurable AIDS-related cancers.
  • For hepatitis B patients: Must have chronic infection or certain antibody markers, and be on anti-HBV therapy if needed.
  • For hepatitis C patients: Must have detectable HCV RNA and be on therapy, or have completed treatment with undetectable RNA.
  • Be over 18 years old.
  • Have a performance status score of 0-2, indicating good overall health.
  • Weigh more than 30 kg.
  • Have adequate organ and bone marrow function, as shown by specific blood tests.
  • Women must be post-menopausal or have a negative pregnancy test.
  • Be willing to follow the study protocol and attend all visits.
  • Have a life expectancy of at least 12 weeks.

Exclusion Criteria

  • Have specific genetic mutations or translocations in the cancer cells.
  • Have co-infections of HIV with hepatitis B or C, unless on appropriate therapy.
  • Have no measurable cancer.
  • Have received cancer treatment within 21 days before starting the study.
  • Have unresolved severe side effects from previous treatments.
  • Have had major surgery within 4 weeks before starting the study.
  • Have a history of organ transplantation.
  • Have active autoimmune or inflammatory disorders, with some exceptions.
  • Have uncontrolled illnesses or infections.
  • Have untreated brain metastases or leptomeningeal disease.
  • Have active tuberculosis.
  • Have used immunosuppressive medication recently, with some exceptions.
  • Have received a live vaccine recently.
  • Be pregnant or breastfeeding, or not using effective birth control.
  • Have allergies to the study drugs.
  • Have received similar immunotherapy drugs recently.
  • Be deemed unsuitable by the investigator.

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