Study on Immunotherapy Combinations for Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Servier Bio-Innovation LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06162572

This clinical trial is testing different combinations of immunotherapy drugs to see if they can effectively treat adults with advanced non-small cell lung cancer (NSCLC) that has not been treated before and shows high levels of a protein called PD-L1.

Patient Parameters

Program Overview

The study is exploring the use of an immunotherapy drug called cemiplimab, combined with one of three other drugs (S095018, S095024, or S095029), in adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has not been treated before. The cancer must have high levels of a protein called PD-L1. The study has two parts: the first part is to find the best dose of the drug combinations, and the second part is to see how well these combinations work. Participants will receive the treatment for up to 108 weeks, or until their cancer progresses or they meet other criteria to stop treatment.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Provide written informed consent to participate.
  • Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery or treated with chemoradiation, or has spread to other parts of the body.
  • Have not received any prior treatment for advanced or metastatic NSCLC.
  • Have high levels of PD-L1 protein in the tumor cells (Tumor Proportion Score of 50% or higher).
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer as defined by standard criteria.

Exclusion Criteria

  • Have specific genetic mutations in the cancer for which targeted treatments are available, such as EGFR, ALK, or ROS1 mutations.
  • Have received prior treatment with immune checkpoint inhibitors.
  • Have active cancer that has spread to the brain.
  • Have active and uncontrolled hepatitis B or C infections.
  • Have uncontrolled HIV infection. Participants with controlled HIV (undetectable viral load and CD4 count above 350) are allowed.
  • Have an active autoimmune disease or immune deficiency.
  • Have a history of severe allergic reactions to the study drugs or similar medications.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have a history of inflammatory bowel disease or colitis.
  • Be on chronic steroid therapy at doses higher than 10mg/day of prednisone or equivalent.
  • Have an active infection requiring antibiotics.
  • Be pregnant or breastfeeding.
  • Have had an organ transplant.
  • Have any medical condition that the study doctor believes would prevent participation.

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