BI 1438-0009/ DAREON-9

Thoracic tumors
Small cell lung carcinoma
Second line + Treatment (Metastatic Disease)
DAREON-9 is an open-label, multicentre, Phase Ib dose escalation and dose confirmation safety study evaluating the bispecific T-cell engager (BiTE) BI 764532 in combination with Topotecan in patients with small cell lung cancer (SCLC). The primary objective is to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of BI 764532 in combination with Topotecan. Eligible participants are adult patients with extensive stage SCLC who have progressed after prior platinum-based chemotherapy and are eligible for Topotecan treatment. BI 764532 is administered intravenously, while Topotecan can be given intravenously or orally. Key secondary endpoints include assessing the safety and tolerability of the combination and evaluating the objective response rate (ORR) and duration of response (DoR) according to RECIST v1.1.
This study is open to adults with advanced-stage small cell lung cancer. The study is being conducted in patients with with relapsed/refractory small cell lung cancer (SCLC) who have previously received platinum-based chemotherapy and are eligible for treatment with topotecan. The aim of this study is to determine the highest dose of BI 764532 that patients can tolerate while taking topotecan. BI 764532 is an antibody-like molecule that can help the immune system fight cancer. Participants will receive BI 764532 and topotecan as an infusion into a vein. Alternatively, topotecan can also be taken orally (in tablet form). Participants can take BI 764532 for as long as they benefit from and tolerate the treatment. During this time, participants will visit the study center regularly. The visits are also based on the response to the treatment. During the study visits, the doctors will check the participants' health, perform the necessary laboratory tests and note any health problems that may have been caused by the study treatment.