Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Launched by GILEAD SCIENCES · Jan 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread to other parts of the body. The trial is focused on using combinations of immunotherapy, a treatment that helps the body’s immune system fight cancer, to see how well it works and how safe it is for patients. Researchers are looking for participants to assess how many patients show a positive response to this treatment.

To be eligible for the trial, participants need to be adults aged 65 to 74 with a confirmed diagnosis of Stage IV metastatic NSCLC and a good level of health (measured by a specific performance scale). They should also have at least one measurable tumor and be willing to provide a sample of their tumor tissue. Participants can expect to receive a combination of immunotherapy treatments, and the study aims to monitor their health and any side effects that may occur. It's important to note that people with certain medical conditions or those who have had specific treatments recently may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically documented Stage IV metastatic, NSCLC
• • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
• • At least one measurable target lesion per RECIST v1.1.
• • Adequate organ function
• • Participants must be willing to provide adequate tumor tissue
• Exclusion Criteria:
• • Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
• • Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
• • Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded).
• • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• • Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.