To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f;
Anhui Cancer Hospital
Hefei, Anhui, China
RECRUITINGProgression Free Survival (PFS)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Baseline until PD or death, whichever occurs first or up to approximately 23 months
Objective Response Rate (ORR)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
Duration Of Response (DOR)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
Disease Control Rate (DCR)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
Time frame: up to approximately 23 months
6-moth/1-year Progression Free Survival (PFS) Rate
The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose.
Time frame: up to approximately 23 months
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1-year Overall Survival (OS) rate
The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose.
Time frame: up to approximately 23 months
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: up to approximately 23 months