BI 1438-0009/ DAREON-9

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive topotecan treatment. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets). Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

This study is open to adults with advanced-stage small cell lung cancer. The study is being conducted in patients with advanced cancer 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.

{ "short_title": "BI 1438-0009/ DAREON-9", "data_mode": "900", "data_mode_number": "000002305", "official_title": "DAREON-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "second", "ctgov_number": "NCT05990738", "eudract_number": null, "general_contact_email": "ectu@ukdd.de", "general_contact_phone": "+49 351-4587566", "hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke", "description_laie_de": "Die Studie wird bei Patienten mit fortgeschrittenem Lungenrebs durchgef\u00fchrt, die zuvor eine platinbasierte Chemotherapie erhalten haben und f\u00fcr eine Behandlung mit Topotecan in Frage kommen. Ziel dieser Studie ist es, die h\u00f6chste Dosis von BI 764532 herauszufinden, die die Patienten bei gleichzeitiger Einnahme von Topotecan vertragen. BI 764532 ist ein antik\u00f6rper\u00e4hnliches Molek\u00fcl, das das Immunsystem bei der Krebsbek\u00e4mpfung unterst\u00fctzen kann. Die Teilnehmer erhalten BI 764532 und Topotecan als Infusion in eine Vene. Alternativ kann Topotecan auch oral (in Tablettenform) eingenommen werden. Die Teilnehmer k\u00f6nnen BI 764532 so lange einnehmen, wie sie von der Behandlung profitieren und diese vertragen. W\u00e4hrend dieser Zeit besuchen die Teilnehmer regelm\u00e4\u00dfig das Studienzentrum. Die Besuche richten sich auch nach dem Ansprechen auf die Behandlung. Bei den Studienbesuchen \u00fcberpr\u00fcfen die \u00c4rzte den Gesundheitszustand der Teilnehmer, f\u00fchren die erforderlichen Laboruntersuchungen durch und notieren alle gesundheitlichen Probleme, die durch die Studienbehandlung verursacht worden sein k\u00f6nnten.", "description_laie_en": "This study is open to adults with advanced-stage small cell lung cancer. The study is being conducted in patients with advanced cancer 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.", "description_expert_de": "Die Studie wird bei Patienten mit fortgeschrittenem Lungenrebs durchgef\u00fchrt, die zuvor eine platinbasierte Chemotherapie erhalten haben und f\u00fcr eine Behandlung mit Topotecan in Frage kommen. Ziel dieser Studie ist es, die h\u00f6chste Dosis von BI 764532 herauszufinden, die die Patienten bei gleichzeitiger Einnahme von Topotecan vertragen. BI 764532 ist ein antik\u00f6rper\u00e4hnliches Molek\u00fcl, das das Immunsystem bei der Krebsbek\u00e4mpfung unterst\u00fctzen kann. Die Teilnehmer erhalten BI 764532 und Topotecan als Infusion in eine Vene. Alternativ kann Topotecan auch oral (in Tablettenform) eingenommen werden. Die Teilnehmer k\u00f6nnen BI 764532 so lange einnehmen, wie sie von der Behandlung profitieren und diese vertragen. W\u00e4hrend dieser Zeit besuchen die Teilnehmer regelm\u00e4\u00dfig das Studienzentrum. Die Besuche richten sich auch nach dem Ansprechen auf die Behandlung. Bei den Studienbesuchen \u00fcberpr\u00fcfen die \u00c4rzte den Gesundheitszustand der Teilnehmer, f\u00fchren die erforderlichen Laboruntersuchungen durch und notieren alle gesundheitlichen Probleme, die durch die Studienbehandlung verursacht worden sein k\u00f6nnten.", "description_expert_en": "This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive topotecan treatment. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets). Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I", "main_cat_id": 10, "sub_cat_id": 51 }

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