DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Rekrutierend
NCT-Nummer:
NCT05882058
Studienbeginn:
September 2023
Letztes Update:
26.03.2024
Wirkstoff:
BI 764532, formulation 1, BI 764532, formulation 2
Indikation (Clinical Trials):
Carcinoma, Small Cell Lung Carcinoma, Neuroendocrine Tumors
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Boehringer Ingelheim
Collaborator:
-
Kontakt
Boehringer Ingelheim Kontakt: Phone: 1-800-243-0127 E-Mail: clintriage.rdg@boehringer-ingelheim.com» Kontaktdaten anzeigen
Studienlocations (3 von 48)
Mobile United States Los Angeles San Francisco Miami Indianapolis Lexington Boston Bronx New York Gent Belgium Leuven Panagyurishte Bulgaria Pleven Chengdu China Hangzhou Jinan Nanchang Shanghai Berlin Germany Dresden Sachsen Erlangen Bayern Deutschland Gauting Großhansdorf Schleswig-Holstein Mainz Rheinland-Pfalz Aichi, Nagoya Japan Chiba, Kashiwa Miyagi, Sendai Osaka, OsakaSayama Osaka, Osaka Tokyo, Chuo-ku Tokyo, Koto-ku Seoul Korea, Republic of Lisboa Portugal Porto Barcelona Spain Madrid Malaga Valencia Tainan Taiwan Taipei Taoyuan County Leicester United Kingdom London Newcastle Upon Tyne
Evangelische Lungenklinik Berlin 13125 Berlin (Berlin) GermanyRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08007234742 E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen Universitätsklinikum Carl Gustav Carus Dresden 01307 Dresden (Sachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08007234742 E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen Hautkrebszentrum Universitätsklinikum Erlangen Ulmenweg 18 91054 Erlangen (Bayern) DeutschlandRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08007234742 E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen Asklepios Fachkliniken München-Gauting 82131 Gauting (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08007234742 E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen LungenClinic Grosshansdorf GmbH 22927 Großhansdorf (Schleswig-Holstein) GermanyRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08007234742 E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen Universitätsmedizin der Johannes Gutenberg-Universität Mainz 55131 Mainz (Rheinland-Pfalz) GermanyRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08007234742 E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen Infirmary Cancer Care 36607 Mobile United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen Valkyrie Clinical Trials 90067 Los Angeles United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen University of California San Francisco 94143 San Francisco United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen University of Miami 33136 Miami United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen Indiana University 46202 Indianapolis United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen University of Kentucky Medical Center 40536 Lexington United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen Dana-Farber Cancer Institute 02215 Boston United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen Montefiore Medical Center 10461 Bronx United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen Laura & Isaac Perlmutter Cancer Center at NYU Langone Health 10016 New York United StatesRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 833-602-2368 E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen UNIV UZ Gent 9000 Gent BelgiumRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 080049616 E-Mail: belgique@bitrialsupport.com» Ansprechpartner anzeigen UZ Leuven 3000 Leuven BelgiumRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 080049616 E-Mail: belgique@bitrialsupport.com» Ansprechpartner anzeigen MHAT UniHospital 4500 Panagyurishte BulgariaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 024903378 E-Mail: balgariya@bitrialsupport.com» Ansprechpartner anzeigen MHAT Heart and brain 5800 Pleven BulgariaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 024903378 E-Mail: balgariya@bitrialsupport.com» Ansprechpartner anzeigen West China Hospital 610041 Chengdu ChinaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 4001200553 E-Mail: china@bitrialsupport.com» Ansprechpartner anzeigen Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine 310016 Hangzhou ChinaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 4001200553 E-Mail: china@bitrialsupport.com» Ansprechpartner anzeigen Qilu Hospital, Shangdong University 250012 Jinan ChinaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 4001200553 E-Mail: china@bitrialsupport.com» Ansprechpartner anzeigen 960 Hospital of the Chinese People's Liberation Army 250031 Jinan ChinaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 4001200553 E-Mail: china@bitrialsupport.com» Ansprechpartner anzeigen The Second Affiliated Hospital to Nanchang University 330006 Nanchang ChinaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 4001200553 E-Mail: china@bitrialsupport.com» Ansprechpartner anzeigen Shanghai Chest Hospital 200030 Shanghai ChinaRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 4001200553 E-Mail: china@bitrialsupport.com» Ansprechpartner anzeigen Aichi Cancer Center Hospital 464-8681 Aichi, Nagoya JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen National Cancer Center Hospital East 277-8577 Chiba, Kashiwa JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen Sendai Kousei Hospital 980-0873 Miyagi, Sendai JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen Kindai University Hospital 589-8511 Osaka, OsakaSayama JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen Osaka International Cancer Institute 541-8567 Osaka, Osaka JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen National Cancer Center Hospital 104-0045 Tokyo, Chuo-ku JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen Japanese Foundation for Cancer Research 135-8550 Tokyo, Koto-ku JapanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0120201230 E-Mail: nippon@bitrialsupport.com» Ansprechpartner anzeigen Severance Hospital 03722 Seoul Korea, Republic ofRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0808802084 E-Mail: namhan@bitrialsupport.com» Ansprechpartner anzeigen Asan Medical Center 05505 Seoul Korea, Republic ofRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0808802084 E-Mail: namhan@bitrialsupport.com» Ansprechpartner anzeigen Samsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0808802084 E-Mail: namhan@bitrialsupport.com» Ansprechpartner anzeigen Hospital CUF Tejo 1350-352 Lisboa PortugalRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 800856070 E-Mail: portugal@bitrialsupport.com» Ansprechpartner anzeigen Hospital CUF Porto 4100-180 Porto PortugalRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 800856070 E-Mail: portugal@bitrialsupport.com» Ansprechpartner anzeigen Hospital del Mar 08003 Barcelona SpainRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 900876092 E-Mail: espana@bitrialsupport.com» Ansprechpartner anzeigen Hospital Vall d'Hebron 08035 Barcelona SpainRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 900876092 E-Mail: espana@bitrialsupport.com» Ansprechpartner anzeigen Hospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 900876092 E-Mail: espana@bitrialsupport.com» Ansprechpartner anzeigen Hospital Virgen de la Victoria 29010 Malaga SpainRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 900876092 E-Mail: espana@bitrialsupport.com» Ansprechpartner anzeigen Hospital Clínico de Valencia 46010 Valencia SpainRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 900876092 E-Mail: espana@bitrialsupport.com» Ansprechpartner anzeigen NCKUH 704 Tainan TaiwanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0809092098 E-Mail: taiwan@bitrialsupport.com» Ansprechpartner anzeigen Taipei Veterans General Hospital 11217 Taipei TaiwanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0809092098 E-Mail: taiwan@bitrialsupport.com» Ansprechpartner anzeigen Chang Gung Memorial Hospital(Linkou) 333 Taoyuan County TaiwanRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 0809092098 E-Mail: taiwan@bitrialsupport.com» Ansprechpartner anzeigen Leicester Royal Infirmary LE1 5WW Leicester United KingdomRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08000514022 E-Mail: unitedkingdom@bitrialsupport.com» Ansprechpartner anzeigen University College Hospital WC1E 6AG London United KingdomRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08000514022 E-Mail: unitedkingdom@bitrialsupport.com» Ansprechpartner anzeigen Freeman Hospital NE7 7DN Newcastle Upon Tyne United KingdomRekrutierend » Google-Maps Ansprechpartner: Boehringer Ingelheim Phone: 08000514022 E-Mail: unitedkingdom@bitrialsupport.com» Ansprechpartner anzeigen Alle anzeigen
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 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.
Inclusion criteria: 1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF). 2. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 3. Histologically or cytologically confirmed, cancer of the following histologies: - Small cell lung cancer (SCLC) - Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC)) - Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue. Patients must have progressed or recurred after standard of care therapy - SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. - epNEC/LCNEC: after at least one platinum-based regimen 4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532. 6. Availability of archival tumour tissue sample. 7. Adequate organ function as defined in the protocol. 8. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade). 9. Women of childbearing potential (WOCBP)and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information Exclusion criteria: 1. Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria: - Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532. - Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease. 2. Presence of leptomeningeal disease. 3. Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade). 4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents. 5. Prior anti-cancer therapy: - Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. - Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532. 6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies. 7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed. 8. Unresolved toxicity from prior anti-tumour therapy, defined as per protocol. Further exclusion criteria apply.
Primary outcome: 1. 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. 2. Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period (Time Frame - up to 23 months)Secondary outcome: 1. 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. 2. 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. 3. 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 4. Overall survival (OS), defined as the time from treatment start until death from any cause (Time Frame - up to 23 months) 5. 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. 6. Change from baseline in EORTC QLQ-C30 role functioning domain score (Time Frame - at baseline, at month 23) 7. Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period (Time Frame - up to 23 months)
Experimental: Dose group 1 Experimental: Dose group 2
BI 764532, formulation 1:BI 764532, formulation 1 BI 764532, formulation 2:BI 764532, formulation 2
Quelle: ClinicalTrials.gov
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