Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes. A 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare. The current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC. This is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
BL0020 will be administered via intravenous infusion on Day 1 of each 21-day treatment cycle.
Toripalimab will be administered via intravenous infusion on Day 1 of each 21-day treatment cycle.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
MTD
Maximum Tolerated Dose (MTD) of BL0020 in combination with Toripalimab
Time frame: Throughout the study for approximately 2 years
RP3D
Recommended Phase 3 Dose (RP3D) of BL0020 in combination with Toripalimab
Time frame: Throughout the study for approximately 2 years
Objective response rate (ORR)
ORR is defined as the proportion of patients with the best responses of Complete Response (CR) and Partial Response (PR) observed after study treatment
Time frame: Throughout the study for approximately 2 years
Duration of response (DOR)
DOR is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until first objective radiographic tumor progression or death from any cause
Time frame: Throughout the study for approximately 2 years
Disease control rate (DCR)
DCR is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates
Time frame: Throughout the study for approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start date of study treatment until first objective radiographic tumor progression or death from any cause
Time frame: Throughout the study for approximately 2 years
Overall survival (OS)
OS is defined as the time from the start date of study treatment until death from any cause
Time frame: Throughout the study for approximately 2 years
12-Month Overall Survival rate (OS12)
OS12 is defined the proportion of patients who are alive 12 months from the start date of the study treatment
Time frame: From the first study treatment to the 12-month time point
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