Small cell lung cancer
Conditions
Interventions
1:PM8002
Sponsors
Jilin Provice Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the clinical study, fully understand the study, voluntarily sign the informed consent form, and are willing to follow and have the ability to complete all the test procedures; 2. Male or female, age = 18; 3. Small cell lung cancer confirmed by histology or cytology; 4. Only received standard first-line chemotherapy or radiochemotherapy (excluding immunotherapy) and failed (defined as disease progression during or after the last treatment, with clear imaging evidence) or did not tolerate standard first-line treatment scheme; 5. Sufficient organ functions; 6. The score of the Eastern United States Cancer Cooperation Group (ECOG) is 0-1; 7. Expected survival time = 12 weeks; 8. According to the RECIST 1.1 standard, the subject has at least one measurable tumor lesion without local treatment in the past (the only bone metastasis or the only central nervous system metastasis is not acceptable as a measurable lesion); 9. The female subjects with fertility had negative blood pregnancy results within 7 days before starting the study and treatment, and were willing to keep abstinence or take medically approved effective contraceptive measures (such as intrauterine devices and condoms) within 6 months after signing the informed consent form to the end of the last medication; 10. Male subjects are willing to abstain or take medically approved effective contraceptive measures within 6 months from signing the informed consent form to the end of the last medication, and do not donate sperm during this period; 11. Subjects must provide archived tumor tissue samples (the archived samples closest to this study are preferred) that are freshly obtained or within 24 months before the study and treatment for PD-L1, ASCL1 and NEUROD1 expression, CD8+T cell infiltration analysis. If the archived samples cannot be obtained, Samples must be collected by biopsy within 28 days before the study treatment (bone biopsy samples, fine needle aspiration biopsy and pleural and ascitic fluid samples are not accepted, and biopsy is not accepted for subjects with only one target lesion for biopsy.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease, severe allergic history of drug (including unlisted test drug) or known allergy to any component of the study drug; 2. Have used immunocheckpoint agonist (such as CD137 agonist) in the past, or immunocheckpoint inhibitor (such as cytotoxic T-lymphocyte associated antigen-4 (CTLA-4), PD-1, PD-L1, LAG3 single/double antibody, etc.); 3. The adverse reactions of the previous anti-tumor treatment have not recovered to the CTCAE 5.0 grade evaluation = 1 (except for the toxicity that the researcher judged to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.); 4. History of hypertensive crisis or hypertensive encephalopathy; 5. Evidence of major bleeding and coagulation disorders or other obvious bleeding risks: 1) History of intracranial hemorrhage or spinal cord hemorrhage; 2) Those with tumor lesions invading large blood vessels and obvious bleeding risk (such as central squamous cell carcinoma of the lung); 3) Within 6 months before the start of study treatment, there were thrombosis or embolism events, or there were significant vascular diseases (such as aortic aneurysm requiring surgical repair); 4) Clinically significant hemoptysis or tumor hemorrhage of any reason occurred within 1 month before screening; 5) Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) was used within 2 weeks before the start of study treatment; 6) Within 10 days before the start of the study, use antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or cilostazol; 7) Coarse needle puncture biopsy or other small operations, excluding the placement of vascular infusion devices, shall be performed within 7 days before the start of the study treatment; 6. When receiving anti-angiogenic therapy in the past, there has been = grade 3 toxicity related to anti-angiogenic therapy (except for the toxicity that the researchers think does not pose a safety risk to the subject); 7. Have received the following treatment or drugs before starting the study treatment: 1) The patient has undergone major organ surgery (excluding puncture biopsy) or significant trauma or dental invasive operation (such as dental implant) within 4 weeks before the start of study treatment, or needs to undergo elective surgery during the trial period; 2) The live attenuated vaccine was used within 4 weeks before the start of study and treatment; 3) He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drugs (including the treatment of unlisted experimental drugs) within 4 weeks before the start of the study; The following cases should also be excluded: received nitrosourea or mitomycin C treatment within 6 weeks before the start of study treatment; Oral fluorouracil and small-molecule targeted drugs have been received 2 weeks before the start of the study or within 5 half-lives of the drug (whichever is longer); He has received Chinese medicine with anti-tumor indications within 2 weeks before starting the study; 4) Having received systemic immune stimulator treatment (such as thymosin, interferon, and interleukin-2) within 4 weeks before the start of the study or still within 5 half-lives of the treatment drug (whichever is longer); 5) Intravenous treatment with broad-spectrum antibiotics within 2 weeks before the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (ObjectiveResponse Rate);TRAEs(Treatment-related Adverse Event); | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(Disease Control Rate);DOR(Duration of Response);PFS(Progress Free Survial);OS(Overall Survival);PK(Pharmacokinetic);ADA(Anti-drug Antibody); | — |
Countries
China
Contacts
Public ContactYing Cheng
Outcome results
None listed