Clinical Trials List
2026-04-01 - 2029-11-30
Phase III
Not yet recruiting6
DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
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Trial Applicant
Boehringer Ingelheim
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- Hsu-ching Huang 無
- Chia-I Shen 無
- 廖映庭 無
- Yuh-Min Chen 無
- 蕭慈慧 無
- Yung-Hung Luo 無
- 趙恒勝 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 李岱晃 無
- 李玫萱 無
- Chih-Jen Yang 無
- Ying-Ming Tsai Tsai 無
- KUAN-LI WU 無
- 郭家佑 無
- Inn-Wen Chong 無
- 莊政皓 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chih-Hsi Kuo 無
- 邱立忠 無
- 吳浩銘 無
- Chien-Ying Liu 無
- Shih-Hong Li 無
- Chih-Liang Wang 無
- 枋岳甫 無
- 黃世緯 無
- Chih-Hung Chen 無
- 柯皓文 無
- Ping-Chih Hsu 無
- Jia-Shiuan Ju 無
- 林定佑 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 吳尚俊 無
- 陳冠宇 無
- CHAO-CHI HO CHAO-CHI HO 無
- Chong-Jen Yu 無
- 蔡子修 無
- 黃信端 無
- 廖唯昱 無
- 于鎧綸 無
- YEN-TING LIN 無
- 錢穎群 無
- 徐偉勛 無
- Jih-Hsiang Lee 無
- James Chih-Hsin Yang 無
- Chia-Chi Lin 無
- 張立群 無
- 許嘉林 無
- 黃俊凱 無
- 廖斌志 無
- 黃得瑞 無
- 楊景堯 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
N/A
N/A
N/A
N/A
Active Ingredient
CARBOPLATIN
ETOPOSIDE
Atezolizumab
Tocilizumab
Dosage Form
N/A
N/A
N/A
N/A
Dosage
10 mg/ml
20 mg/ml
60 mg/ml
Endpoints
Inclution Criteria
Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.
Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.
Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:
Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation
Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy
Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.
Exclusion Criteria
Presence of leptomeningeal disease and/or carcinomatous meningitis
Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
Radiotherapy of any anatomical site within 7 days prior to randomisation
Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and/or CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described
Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
670 participants
