For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients could not achieve complete pathological response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains the function of immune cells and leads to immune escape of tumor cells. The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC.
The patient shall sign the Informed Consent Form.
Aged 18 ≥ years.
Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
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;
Sequential
Toripalimab
DrugSpecified dose on specified days.
JS004
DrugSpecified dose on specified days.
Pemetrexed
DrugSpecified dose on specified days.
Nab-paclitaxel
DrugSpecified dose on specified days.
Carboplatin
DrugSpecified dose on specified days.
Surgery
Procedure/SurgeryPatients with resectable tumor after neoadjuvant therapy will be treated with surgery.
Pathologic complete response (PCR) rate
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Major pathologic response (MPR) rate
MPR rate is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants.
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Rate of conversion from potentially resectable to resectable
Rate of conversion from potentially resectable to resectable is defined as the proportion of participants with potentially resectable tumor conversed into resectable tumor in all participants with potentially resectable tumor.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
