Clinical Trials List
Protocol NumberM24-633
NCT Number(ClinicalTrials.gov Identfier)NCT07155174
Active
2025-12-01 - 2032-01-31
Phase II
Not yet recruiting1
SEZanne: A Phase 2 Randomized, Open label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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Trial Applicant
AbbVie
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Sponsor
ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH (SWITZERLAND)
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/11
Investigators and Locations
Co-Principal Investigator
- Inn-Wen Chong 無
- Chih-Jen Yang 無
- 李玫萱 無
- Ying-Ming Tsai Tsai 無
- 郭家佑 無
- 莊政皓 無
- 李岱晃 無
Co-Principal Investigator
- Yuh-Min Chen 無
- Yung-Hung Luo 無
- 趙恒勝 無
- Hsu-ching Huang 無
- 廖映庭 無
Principal Investigator
Cheng-Ta Yang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Small Cell Lung Cancer
Objectives
Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.
In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Test Drug
ABBV-706
Active Ingredient
ABBV-706
Dosage Form
N/A
Dosage
N/A
Endpoints
Number of Participants with Adverse Events (AE)s An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Up to 69.5 Months
Progression-Free Survival (PFS) Based on Investigator Assessment PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first. Up to Approximately 24 Months
Progression-Free Survival (PFS) Based on Investigator Assessment PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first. Up to Approximately 24 Months
Inclution Criteria
Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.
Exclusion Criteria
Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).
Known active/symptomatic central nervous system (CNS) metastases should be excluded.
History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded.
Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.
Known active/symptomatic central nervous system (CNS) metastases should be excluded.
History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded.
Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
180 participants
