Study of JS004 Combined With Toripalimab for Advanced Lung Cancer

Inclusion Criteria：

1. Sign the informed consent form voluntarily;

2. Age greater than or equal to 18 years old at time of signing informed consent, malesand females are included;

3. Expected survival time is greater than or equal to 3 months;

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

5. Pathologically confirmed locally advanced (Stage III B/C), metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC);

6. Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC, accordingto the Veterans Administration Lung Study Group (VALG) staging system);

7. At least one measurable lesion as a target lesion (RECIST v1.1 criteria);

8. Agree to provide tumor tissue samples (provide fresh biopsy samples before treatmentas far as possible，provide archived samples within 2 years for patients who cannotprovide fresh biopsy samples before treatment;

9. The subject has good organ function as indicated by screening laboratory results；

10. Males of reproductive potential or females of childbearing potential must useeffective contraceptive methods (such as oral contraceptives, intrauterine device orbarrier method combined with spermicide) during the trial and continue contraceptionfor 6 months after the end of treatment;

11. Good compliance and cooperated with the follow-up；

Exclusion Criteria:

1. Within 2 years prior to enrollment, had other active neoplasm malignancies exceptfor the study disease, but excluding neoplasm malignancies expected to be curedafter treatment (including but not limited to thyroid cancer, carcinoma cervix insitu, basal or squamous cell skin carcinoma, or ductal carcinoma in situ afterradical surgery after adequate treatment);

2. Patients previously treated with anti-BTLA or anti-HVEM antibodies;

3. Patients previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;

4. Adverse reaction caused by prior treatment that has not recovered to CTCAE Grade 1and below (except Grade 2 toxicity that is long-lasting, not recoverable, and doesnot increase safety risk);

5. Received allogeneic hematopoietic stem cell transplantation or solid organtransplantation in the past;

6. A large amount of hydrothorax or ascites or pericardial effusion with clinicalsymptoms or requiring symptomatic treatment;

7. Known history of Lung disorder: history of Interstitial pneumonia/drug-inducedinterstitial Pneumopathy or pneumonia, symptomatic Bronchospasm;

8. Active infection requiring systemic therapy;

9. A positive result for human immunodeficiency virus (HIV) antibody test;

10. Known active tuberculosis (TB). For patients with suspicion of active TB shouldperform the test of chest X-ray, sputum, clinical signs and symptoms to exclude；

11. Have a history of psychotropic drug abuse and unable to withdraw or have mentaldisorders;

12. Pregnant or lactating woman;

13. Known to be allergic to JS004 or toripalimab and its components;

14. Other severe, acute or chronic medical or psychiatric disorders or laboratoryabnormalities that, in the investigator's opinion, may increase the risk associatedwith study participation or may interfere with the interpretation of study results；