DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
- Conditions
- Small Cell Lung CarcinomaNeuroendocrine NeoplasmsExtra-pulmonary Neuroendocrine Carcinoma
- Interventions
- Drug: BI 764532, dose 1Drug: BI 764532, dose 2
- Registration Number
- NCT05882058
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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. 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.
The study has 2 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2, all participants receive the same dose of BI 764532. Part 2 is open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma.
All participants receive BI 764532 as an infusion 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 overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 174
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Dose group 1 BI 764532, dose 1 - Part 1: Dose group 2 BI 764532, dose 2 - Part 2: Expansion cohort BI 764532, dose 1 -
- Primary Outcome Measures
Name Time Method Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) up to 26 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.
Part 1: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period up to 26 months Part 2: Objective response (OR) up to 27 months Objective response is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v 1.1 by blinded independent central review 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
- Secondary Outcome Measures
Name Time Method Part 1: Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment up to 26 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
Part 1: Overall survival (OS), defined as the time from treatment start until death from any cause up to 26 months Part 1: Duration of objective response (DOR) based on investigator assessment up to 26 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.
Part 1: Progression-free survival (PFS) based on investigator assessment up to 26 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.
Part 1: Change from baseline in EORTC QLQ-C30 physical functioning domain score at baseline, at month 26 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 (physical, role, cognitive, emotional, and social),
* three symptom scales (fatigue, pain, and nausea and vomiting),
* 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.Part 1: Change from baseline in EORTC QLQ-C30 role functioning domain score at baseline, at month 26 Part 1: Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period up to 26 months Part 2: Duration of objective response (DOR) based on blinded independent central review up to 27 months Part 2: Progression-free survival (PFS) based on blinded independent central review up to 27 months Part 2: Disease control (DC) based on blinded independent central review up to 27 months Part 2: Overall survival (OS), defined as the time from treatment start until death from any cause up to 27 months Part 2: Change from baseline in EORTC QLQ-C30 physical functioning domain score up to 27 months Part 2: Change from baseline in EORTC QLQ-C30 role functioning domain score up to 27 months Part 2: Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period up to 27 months Part 2: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period up to 27 months
Trial Locations
- Locations (60)
Evangelische Lungenklinik Berlin
🇩🇪Berlin, Germany
Mayo Clinic-Arizona
🇺🇸Phoenix, Arizona, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Mayo Clinic Cancer Center
🇺🇸Jacksonville, Florida, United States
Kansas University Medical Center
🇺🇸Fairway, Kansas, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
West China Hospital
🇨🇳Chengdu, China
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
NCKUH
🇨🇳Tainan, Taiwan
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Infirmary Cancer Care
🇺🇸Mobile, Alabama, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
University of Miami
🇺🇸Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
🇺🇸New York, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University Health- Adult Outpatient Pavilion
🇺🇸Richmond, Virginia, United States
UNIV UZ Gent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
MHAT UniHospital
🇧🇬Panagyurishte, Bulgaria
MHAT Heart and brain
🇧🇬Pleven, Bulgaria
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, China
Qilu Hospital, Shangdong University
🇨🇳Jinan, China
960 Hospital of the Chinese People's Liberation Army
🇨🇳Jinan, China
The Second Affiliated Hospital to Nanchang University
🇨🇳Nanchang, China
Shanghai Chest Hospital
🇨🇳Shanghai, China
HOP Intercommunal
🇫🇷Créteil, France
HOP Cochin
🇫🇷Paris, France
HOP Civil
🇫🇷Strasbourg, France
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Asklepios Fachkliniken München-Gauting
🇩🇪Gauting, Germany
LungenClinic Grosshansdorf GmbH
🇩🇪Großhansdorf, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Aichi Cancer Center Hospital
🇯🇵Aichi, Nagoya, Japan
Sendai Kousei Hospital
🇯🇵Miyagi, Sendai, Japan
Kindai University Hospital
🇯🇵Osaka, OsakaSayama, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Osaka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Japanese Foundation for Cancer Research
🇯🇵Tokyo, Koto-ku, Japan
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital CUF Descobertas-Lisboa-69316
🇵🇹Lisboa, Portugal
Hospital CUF Porto
🇵🇹Porto, Portugal
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital(Linkou)
🇨🇳Taoyuan County, Taiwan
The Christie
🇬🇧Manchester, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom