Study on New Treatment Combinations for Lung Cancer Patients

Sponsor: Gilead Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05633667

Provider View

This clinical trial is exploring new treatment combinations for patients with different stages of non-small-cell lung cancer (NSCLC). The study aims to compare these new treatments with the current standard care to see which works better.

Patient Parameters

Program Overview

The purpose of this study is to test how well new treatment combinations work for people with lung cancer. There are three parts to the study: Substudy-01 will look at patients with advanced lung cancer that has spread and who haven't been treated before. Substudy-02 will focus on patients whose cancer has worsened after previous treatment. Substudy-03 will involve patients with lung cancer that can be surgically removed. The main goals are to see how well the cancer responds to the treatments and how effective the treatments are in completely removing the cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-small-cell lung cancer (NSCLC).
  • No known genetic changes that have specific treatments available.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer according to standard criteria.
  • Have good blood and organ function.
  • Agree to use contraception if of childbearing potential and engaging in heterosexual intercourse.

Substudy 01:

  • Have advanced (Stage IV) NSCLC.
  • For those with a specific type of lung cancer (nonsquamous), must not have certain genetic changes (EGFR or ALK).
  • Have a confirmed PD-L1 status.
  • Have not received any prior treatment for advanced NSCLC.

Substudy 02:

  • Have advanced (Stage IV) NSCLC.
  • If there are specific genetic changes (EGFR, ALK, or others), must have received at least one targeted therapy.

Substudy 03:

  • Have not been treated before and have lung cancer that can be surgically removed (Stage II, IIIA, IIIB).
  • Surgery must involve specific types of lung removal.
  • Have a confirmed PD-L1 status.
  • For those with a specific type of lung cancer (nonsquamous), must not have certain genetic changes (EGFR or ALK).

Exclusion Criteria

  • Have a mix of small-cell lung cancer and NSCLC.
  • Have another active cancer.
  • Have an active autoimmune disease.
  • Have a history of or current lung inflammation not caused by infection.
  • Have a serious infection within 4 weeks before starting the study.

Substudy 01 and 02:

  • Have active cancer spread to the brain or spinal fluid.
  • Have received cancer treatment within 4 weeks before joining the study.

Substudy 03:

  • Have received previous treatment for NSCLC with drugs or radiation.
  • Have been treated with any immune checkpoint inhibitors before.

Note: Other specific criteria may apply.

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