Study on Nivolumab and Ramucirumab for Patients with Recurrent, Advanced, Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03527108

Provider View

This clinical trial is exploring a combination of two drugs, Nivolumab and Ramucirumab, to see if they can help control advanced non-small cell lung cancer (NSCLC) that has returned or spread after previous treatments.

Patient Parameters

Program Overview

The study aims to find out if combining Nivolumab, an immune checkpoint inhibitor, with Ramucirumab, a drug that targets blood vessel growth in tumors, can improve survival in patients with advanced NSCLC. This combination targets two different pathways that help the immune system fight cancer. The trial will include patients who have had previous immunotherapy treatments, regardless of their PD-L1 levels, and will focus on the rate of disease control as the main outcome.

Description

This study is testing a new treatment approach for advanced non-small cell lung cancer (NSCLC) by combining two drugs: Nivolumab, which helps the immune system attack cancer cells, and Ramucirumab, which blocks the growth of blood vessels that tumors need to grow. Researchers believe that using these two drugs together might be more effective than using them separately. The study will look at how well this combination works in controlling the cancer and whether it can improve survival rates. Patients who have previously received immunotherapy, either alone or with chemotherapy, can participate. The study will monitor the safety and effectiveness of this treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) that has returned or is not responding to treatment.
  • Have at least one tumor that can be measured by scans.
  • Have completed at least one previous treatment for NSCLC, including specific chemotherapy or immunotherapy regimens.
  • Be 18 years or older.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have normal organ and bone marrow function based on specific blood tests.
  • Be able to provide a recent tumor biopsy sample.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after.
  • Men must agree to use effective contraception if their partners are of childbearing potential.
  • Be willing to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Have not fully recovered from previous cancer treatments.
  • Have received Ramucirumab before.
  • Have had significant bleeding or blood clotting issues recently.
  • Have severe liver disease or other serious health conditions.
  • Have uncontrolled high blood pressure.
  • Have a history of coughing up blood or tumors involving major blood vessels.
  • Have serious wounds or fractures that are not healing.
  • Have had major surgery recently.
  • Are taking certain medications that affect blood clotting.
  • Have active autoimmune diseases requiring treatment.
  • Have untreated or unstable brain metastases.
  • Have lung diseases like interstitial lung disease or active infections like tuberculosis.
  • Have received a live vaccine recently.
  • Have other serious health conditions that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Have a history of severe side effects from similar treatments.

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