A Comparison of New Immunotherapies in Combination with Chemotherapy or Chemotherapy Alone in Patients with Advanced, Previously Treated Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is a malignant disease in which cells in the lungs multiply uncontrollably and can destroy healthy tissue. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer and generally grows more slowly than small cell lung cancer. In advanced stages of the disease (stage II and beyond), surgical removal of the tumor alone is often no longer sufficient. In such cases, chemotherapy or immunotherapy is used as an adjunct treatment. Immunotherapies specifically activate the body’s own immune system against cancer cells by binding to specific target structures on immune or tumor cells.

These studies are investigating two new immunotherapies: The study drug cobolimab binds to the TIM-3 protein, while dostarlimab binds to the PD-1 protein on immune cells. Neither drug has yet been approved for the treatment of NSCLC. The therapy is supplemented with docetaxel, an approved chemotherapy drug that is already used as monotherapy when the disease recurs after initial treatment.

The goal of this Phase 2/3 study is to investigate the efficacy and safety of the combination therapy of cobolimab, dostarlimab, and docetaxel compared to dostarlimab plus docetaxel or docetaxel alone. As part of the study, patients will be randomly assigned to three groups. Group 1 will receive the combination therapy consisting of cobolimab, dostarlimab, and docetaxel; Group 2 will receive the combination of dostarlimab and docetaxel; and Group 3 will receive docetaxel alone. The study is open-label, meaning that both medical staff and patients know which medications are being administered. Overall survival will be monitored for up to 52 months after the start of the study.

Women and men aged 18 and older with advanced or metastatic NSCLC are eligible to participate in this study. The disease must be demonstrably progressive despite a maximum of two prior treatments with platinum-based chemotherapy and PD-L1 or PD-1 antibodies. Participation is only possible if certain genetic alterations (EGFR, ALK, and ROS1 mutations) have been ruled out and the patients have not previously been treated with anti-TIM-3 or anti-CTLA-4 therapy or docetaxel.