CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC)

Inclusion Criteria:

* Histologically or cytologically confirmed recurrent, inoperable, metastatic SCLC (stage III/IV period);
* Progressive disease after prior standard systemic treatment;
* Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1;
* Life expectancy of at least 12 weeks;
* At least one measurable lesion according to the RECIST 1.1;
* Adequate organ functions;
* Negative serum pregnancy test results within 7 days prior to the first dose of the study drug;
* Patients willing to obey the schedule for study and follow-up procedures;
* Patients who can understand the nature of the study and sign voluntarily the informed consent.

Exclusion Criteria:

* Patients who have previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or VEGFR TKI therapy (sunitinib, sorafenib, pizopren, axitinib, bevacizumab, remomituzumab, nidanib, vandetanib, etc), or CTLA-4 inhibitor (Ipilimumab, etc).
* Patients who are presently receiving other systematic antitumor therapies.
* Patients who developed other malignancies (not including cured basal cell tumor of skin, endoscopically resected early gastrointestinal tract \[GI\] tumor, and cervical carcinoma in situ) except lung cancer in the past 2 years.
* Patients receiving a major surgery or immunotherapy in the past 4 weeks prior to the first dose; and patients receiving a radiotherapy within 2 weeks prior to the first dose.
* Patients with brain metastases or meningeal metastases.
* Have received hematopoietic stimulating factors within 1 week prior to the first dose of the study drug.
* Patients who previously received stem cell transplantation or organ transplantation.
* Patients with swallowing dysfunction, active gastrointestinal disease, or other disorders that may influence significantly absorption, distribution, metabolism, or excretion of CM082.
* Patients with active hepatitis B, hepatitis C virus antibody positive , HIV antibodies, or treponema pallidum antibody positive.
* Patients with a prior history of interstitial lung disease, history of drug-induced interstitial lung disease, history of radiation pneumonia requiring a steroid therapy, or any clinical indications for active interstitial lung disease.
* Patients who are known to be allergic to JS001 or CM082 or any excipients of the study drugs.
* Patients receiving in the past 14 days or requiring concurrently the following drugs during treatment: Drugs that may result in a risk for QTc prolongation and/or torsades de pointes; or CYP3A potent inhibitors or potent inducers.
* Patients with other severe, acute or chronic medical conditions (including incontrollable diabetes mellitus, or medical disease or mental disease, or laboratory test abnormality) that may increase study-related risk or may interfere with interpretation of the research results, in the viewpoints of the investigator.
* Patients with other conditions that not suitable to participate in this study, as considered by the investigator.