This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.

Study Summary

This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer. Such medicines are called immune checkpoint inhibitors. The study has two parts. In the first part, doctors want to find out the highest dose of 2 medicines that people with solid tumors can tolerate. This dose is then used for the second part of the study. In the second part, the combination of the two medicines is tested in patients with non-small cell lung cancer and other types of solid cancer. These patients had gotten treatment with anti-PD-1 or anti-PD-L1 medicines but their tumors have come back. The doctors check whether the combination of BI 754111 and BI 754091 makes tumors shrink. Both medicines are given as an infusion into the vein every 3 weeks. If there is benefit for the patients and if they can tolerate it, the treatment is given for maximum of 1 year. During the entire study doctors will regularly check the health of the patients.

Primary Outcome

The MTD is defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33%. DLTs include: Haematologic toxicities: * Any Grade 5 toxicity * Neutropenia ≥ Grade 4 for \>5 days * Any duration febrile neutropenia * Grade 4 thrombocytopenia or Grade 3 with bleeding/platelet transfusion need * Unexplained Grade 4 anaemia. Non-haematological toxicities: * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x Upper limit of normal

Interventions

• DRUG Ezabenlimab
• DRUG BI 754111