Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

BI 764532

Boehringer Ingelheim

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.

DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan

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

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Neuroendocrine Tumors

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Successive cohorts of patients will receive increasing doses of BI 764532 in combination with ezabenlimab until the maximum tolerated dose (MTD) is reached, or upon decision of Dose Escalation Committee (DEC).

Ezabenlimab

This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.

The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with another medicine called ezabenlimab. BI 764532 and ezabenlimab are antibodies that may help the immune system fight cancer. Participants get BI 764532 and ezabenlimab as infusions into a vein.

If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about every week. 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.

A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Objective response, defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined by the investigator's assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in patients with measurable disease from date of first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent

Atezolizumab

Carboplatin

Etoposide

Cisplatin

Durvalumab

Etoposide phosphate

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy.

The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein.

If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. 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.

DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

DAREONᵀᴹ-8: A Phase I, Open-label, Dose Escalation and Expansion Trial of Repeated Intravenous Infusions of BI 764532 Combined With Standard of Care (Platinium, Etoposide, and Anti-PD-L1) in Patients With Extensive-stage Small Cell Lung Carcinoma

OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent

DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response

Carcinoma, Neuroendocrine

[89Zr]Zr-BI 764532

This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.

Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.

A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer

An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan	NCT05990738	Small Cell Lung...	BI 764532 Topotecan	18 Years -	Boehringer Ingelheim
A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3	NCT05879978	Small Cell Lung... Neuroendocrine ...	BI 764532 Ezabenlimab	18 Years -	Boehringer Ingelheim
DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer	NCT06077500	Small Cell Lung...	BI 764532 Carboplatin Etoposide Atezolizumab Durvalumab Cisplatin	18 Years -	Boehringer Ingelheim
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan	NCT05990738	Small Cell Lung...	BI 764532 Topotecan	18 Years -	Boehringer Ingelheim
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan	NCT05990738	Small Cell Lung...	BI 764532 Topotecan	18 Years -	Boehringer Ingelheim
A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer	NCT05963867	Small Cell Lung... Neuroendocrine ...	BI 764532 [89Zr]Zr-BI 764...	18 Years -	Boehringer Ingelheim

Spots Global Cancer Trial Database for small cell lung carcinoma (sclc)