For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.
The patient shall sign the Informed Consent Form;
Aged 18 ≥ years;
Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
Patients with a malignancy other than SCLC within five years prior to the start of this trial;
Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
Participants who are allergic to the test drug or any auxiliary materials;
Parallel
JS004
DrugSpecified dose on specified days.
Toripalimab
DrugSpecified dose on specified days.
Etoposide
DrugSpecified dose on specified days.
Platinum
DrugSpecified dose on specified days.
Progression-free survival (PFS)
It is defined as the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Overall survival (OS)
It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Health related quality of life (HRQol)：EORTC-QLQ-C30
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 , Version 3). EORTC's QLQ-C30 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options.
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