This study is a phase 2 open-label, multicenter clinical study to evaluate the efficacy and safety SKB264 in combination with pembrolizumab in patients with unresectable stage III non-small cell lung cancer.
This study is a phase 2 open-label, multicenter clinical study to evaluate the efficacy and safety SKB264 in combination with pembrolizumab in patients with unresectable stage III non-small cell lung cancer. The study includes a screening period (up to 28 days after the subject signs the informed consent form until before the first dose), a treatment period (including an induction treatment period, a local treatment period (surgery or radical radiotherapy), and a consolidation treatment period), and a follow-up period (including two parts of safety follow-up and survival follow-up). Approximately 50 patients with initially unresectable stage III non-small cell lung cancer patients, without EGFR/ALK/ROS-1-sensitive mutations, without chest radiotherapy and systemic anti-tumor therapy, were enrolled and treated with Sacituzumab tirumotecan (SKB264) in combination with pembrolizumab until disease progression, intolerable toxicity, or meeting the criteria for discontinuation of the trial drug. The primary endpoint is the investigator-assessed 18-month progression-free survival (PFS) rate of intention-to-treat population (ITT). Secondary endpoints include event-free survival (EFS), overall survival (OS), R0 surgical resection rate, complete response (pCR) rate, major pathological response (MPR) rate and safety, objective response rate (ORR) in the induce treatment period. Recruitment for the study is expected to begin in mainland China around January 2025, with the trial anticipated to conclude in January 2028.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants meeting the inclusion criteria will receive pembrolizumab 200 mg IV on D1, Q3W + SKB264 4mg/kg IV on D1, D15 and D29,Q2W for 12 weeks as induction therapy. Subjects who receive radical radiotherapy will undergo 8 cycles of pembrolizumab 200 mg IV on D1, Q3W; For those receiving surgical treatment, pembrolizumab is selected for adjuvant therapy for pCR patients, and SKB264 combination with pembrolizumab is selected non-PCR patients.
Hunan Provincal Tumor Hospital
Changsha, Hunan, China
18m EFS rate
18-month progression-free survival (PFS) rate
Time frame: Time from the first dose treatment to 18 months
Event-free survival (EFS)
Defined as the time from the first dose treatment to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Time frame: Time from first subject enrollment to study completion, or up to 60 months
R0 surgical resection rate
No residual ratio under the microscope after surgical resection
Time frame: Time from the first subject dose to study completion, or up to 60 months
Complete Response (pCR) rate
Defined as the absence of active tumors in lesions at the time of surgical resection of primary tumors.
Time frame: Time from the first subject dose to study completion, or up to 60 months
Major Pathological Response (MPR) rate
Defined as the incidence of ≤10% active tumors in lesions at the time of surgical resection of primary tumors.
Time frame: Time from the first subject dose to study completion, or up to 60 months
Objective response rate (ORR)
The ORR of ITT after SKB264 combined with pembrolizumab was evaluated according to the investigator's Solid Tumor Response Assessment Criteria (RECIST) version 1.1, defined as the proportion of subjects who were evaluated for complete response (CR) + partial response (PR) after induce treatment
Time frame: Time from the first subject dose to study completion, or up to 60 months
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Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame: From the first dose to 28 days after the last dose, until 36 months
Overall survival (OS)
Defined as the time from the first dose treatment to death.
Time frame: Time from the first subject dose to study completion, or up to 60 months