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

This is an interventional treatment trial for Small Cell Lung Cancer Read More

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.