DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
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|ClinicalTrials.gov Identifier: NCT05882058|
Recruitment Status : Not yet recruiting
First Posted : May 31, 2023
Last Update Posted : September 25, 2023
This study is open to adults with small cell lung cancer and other neuroendocrine tumours. 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 a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer.
Participants are put into 2 groups randomly, which means by chance. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. Participants get BI 764532 infusions into a vein when starting treatment. 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. The first study visits include an over-night stay to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Carcinoma Neuroendocrine Neoplasms||Drug: BI 764532||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed/Refractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed/Refractory Neuroendocrine Carcinomas|
|Estimated Study Start Date :||September 27, 2023|
|Estimated Primary Completion Date :||September 25, 2024|
|Estimated Study Completion Date :||July 3, 2025|
|Experimental: Dose group 1||
Drug: BI 764532
|Experimental: Dose group 2||
Drug: BI 764532
- Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) [ Time Frame: up to 23 months ]according to RECIST v 1.1 by investigator 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.
- Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period [ Time Frame: up to 23 months ]
- Duration of objective response (DOR) based on investigator assessment [ Time Frame: up to 23 months ]DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR.
- Progression-free survival (PFS) based on investigator assessment [ Time Frame: up to 23 months ]PFS is defined as the time from treatment start until the earliest date of tumour progression according RECIST v 1.1 or death from any cause, whichever occurs first.
- Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment [ Time Frame: up to 23 months ]where best overall response is defined according to RECIST v 1.1, from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent
- Overall survival (OS), defined as the time from treatment start until death from any cause [ Time Frame: up to 23 months ]
- Change from baseline in EORTC QLQ-C30 physical functioning domain score [ Time Frame: at baseline, at month 23 ]
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) The QLQ-C30 is comprised of 30 questions. It incorporates both multi-item scales and single-item measures. These include one global health status/Quality of Life (QoL) scale, five functional scales, three symptom scales and six single items to assess dyspnea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.
All scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
- Change from baseline in EORTC QLQ-C30 role functioning domain score [ Time Frame: at baseline, at month 23 ]
- Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period [ Time Frame: up to 23 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05882058
|Contact: Boehringer Ingelheimemail@example.com|