This is a randomized, controlled, open-label, multicenter clinical study to evaluate the efficacy and safety of carboplatin/cisplatin + etoposide + benmelstobart sequential benmelstobart combined with anlotinib versus carboplatin/cisplatin + etoposide + Tislelizumab sequential Tislelizumab in the first-line treatment of extensive stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Carboplatin for injection inhibits DNA synthesis, thereby preventing cancer cell division and reproduction/Cisplatin for injection binds to DNA, interfering with DNA replication and transcription processes, Thus inhibiting tumor cell proliferation/etoposide injection interferes with the division process of cancer cells to inhibit their growth and spread/Bemosubebezumab injection is a humanized recombinant anti-Programmed cell death ligand 1 (PD-L1) monoclonal antibody/Anlotinib hydrochloride capsule is a tyrosine kinase inhibitor.
Carboplatin for injection inhibits DNA synthesis and thus prevents the division and reproduction of cancer cells/Cisplatin for injection binds to DNA and interferes with the DNA replication and transcription process, thereby inhibiting the proliferation of tumor cells/etoposide injection interferes with the division process of cancer cells to inhibit their growth and spread/Tislelizumab injection is a humanized recombinant anti-PD-1 monoclonal antibody.
Maanshan People's Hospital
Maanshan, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University People´s Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University 2nd Affiliated Hospital
Quanzhou, Fujian, China
Progression free survival (PFS)
The time from enrollment until the first onset of disease progression or death from any cause, whichever occurs first.
Time frame: From enrollment until the first onset of disease progression or death from any cause, evaluation is expected to take 2 years
12/24 month PFS rate
The percentage of subjects with no progression from the first dose to 12 and 24 months of total subjects.
Time frame: 12-month, 24-month
12/24 month Overall survival (OS) rate
The number of surviving subjects as a percentage of the total number of subjects from the first dose to 12 and 24 months.
Time frame: 12-month, 24-month
Overall survival (OS)
The time between randomization and death from all causes.
Time frame: From randomization to death from all causes, evaluation is expected to take 5 years
Objective response rate (ORR)
The proportion of subjects achieving complete response (CR) or partial response (PR) was assessed.
Time frame: Complete response time was achieved, evaluation is expected to take 2 years
Disease Control Rate (DCR)
The proportion of subjects who achieved complete response (CR), partial response (PR), or stable disease (SD) was assessed.
Time frame: Complete response time was achieved, evaluation is expected to take 2 years
Incidence of adverse events (AE) and serious adverse events (SAE)
The incidence and severity of adverse events were determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 rating scale.
Time frame: Time of adverse event, evaluation is expected to take 2 years
Patient-reported Outcomes (PRO): Treatment of Cancer Quality of Life Questionnaire - Core 30
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). Treatment of Cancer Quality of Life Questionnaire - Core 30 were used to evaluate PRO. The EORTC QLQ-C30 v3 questionnaire is an established measure of health-related quality of life (HRQoL)Methods, it is often used as the end point of tumor clinical trials.A score of 0-100, where higher scores indicate greater function, higher HRQoL, or higher symptom levels.
Time frame: PRO assessments were performed during the screening period, at the end of each even-numbered cycle, at the end of study treatment, and at safety follow-up in the order shown, baseline to 2 years
Patient-reported Outcomes (PRO): EORTC QLQ-LC13
EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) QLQ-LC13 were used to evaluate PRO.The QLQ-LC13 is a 13-item self-filling questionnaire for lung cancer disease that will be associated with the EORTC Use QLQ-C30 together.4-point scale: "Not at all", "somewhat", "quite a bit" and "to a great extent"
Time frame: PRO assessments were performed during the screening period, at the end of each even-numbered cycle, at the end of study treatment, and at safety follow-up in the order shown, baseline to 2 years
Patient-reported Outcomes (PRO): European Quality of Life-5 Dimensions 5 Levels
European Quality of Life-5 Dimensions 5 Levels were used to evaluate PRO. EuroQol- 5 Dimension (EQ-5D) is a standardized health status indicator developed by the EuroQol group, which asseses five dimensions: mobility, self-care, general activity, pain/discomfort, and anxiety/depression.Each dimension has five response options that reflect increased difficulty (no problem, some problem, moderate problem, severe)Serious problem (extremely serious problem).
Time frame: PRO assessments were performed during the screening period, at the end of each even-numbered cycle, at the end of study treatment, and at safety follow-up in the order shown, baseline to 2 years
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