Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old, male or female, signed Informed Consent Form (ICF);
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Histologically or cytologically confirmed ES-SCLC;
No prior systemic treatment for ES-SCLC;
Disqualifiers
Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
Was administered a live vaccine ≤ 4 weeks before treatment;
Active autoimmune diseases or history of autoimmune diseases that may relapse;
Trial design
Design model
Single group
Treatments tested in this trial
Tislelizumab, Carboplatin /Cisplatin, Etoposide
DrugInduction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Tislelizumab plus chemo and radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression 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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov