non-small-cell lung cancer
Conditions
Interventions
Single arm:AK104 in combination with carboplatin and pemetrexed (squamous) or albumin-bound paclitaxel (non-squamous)
Sponsors
Cancer Hospital Affiliated to Shandong first medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18,male or female; 2. Pathological or imaging confirmed as stage IIIB or IIIC non-small-cell lung cancer (staging according to the American Joint Commission on Cancer version 8) and previously untreated, clinically determined as unresectable lesions, but with indications for radical radiotherapy and chemotherapy treatment; 3. PD-L1 TPS=50%; 4. Driver genes such as EGFRALKROS1BRAF V600 are wild type or targeted drugs not accessible; 5. ECOG PS 0 or 1; 6. Measurable lesion (must have at least one evaluable lesion according to the RECIST version 1.1, with a maximum diameter of at least 10mm. If the CT scan layer thickness is>5mm, the lesion diameter should be at least twice the layer thickness; if the lesion is a lymph node, the short diameter should be measured at least 15mm); 7. Sufficient organ and bone marrow function; 8. It is necessary to provide approximately 10 unstained FFPE pathological sections (preferably newly obtained tumor tissue samples) of locally advanced tumor tissue diagnosed as unresectable; 9. No metastatic diseases were found in the whole body PET/CT scan (recommended), diagnostic CT scan, and brain imaging; 10. Adequate lung function testing; 11. For female subjects of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. If there is a risk of conception, all subjects (whether male or female) need to adopt a low annual failure rate during the entire treatment period until 120 days after the last study drug administration; 12. Be able to understand and sign a written informed consent, and the subjects are willing and able to comply with the visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Has any histologically small cell carcinoma component; 2. A history of other malignancies within 3 years; 3. Previous treatment with systemic anti-tumor treatments; 4. Is currently participating in a study of an investigational agent or using an investigational device; 5. Palliative local treatments on non-target lesions and non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, tumor necrosis factor, etc. excluding IL-11 used for treating thrombocytopenia) within 2 weeks prior to the first dose of study treatment; 6. Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc 7. History of coagulation dysfunction, high risk of bleeding and hemoptysis; Has significant bleeding symptoms within 1 month, continuous antiplatelet or anticoagulant treatment within 10 days prior to day 1 of study treatment; 8. History of interstitial lung disease, drug-induced interstitial lung disease or radiation pneumonia; 9. Has an active infection requiring systemic therapy within 4 weeks prior to day 1 of study treatment; 10. History of active comorbidities; 11. History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment; 12. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; 13. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy prior to the first dose of study treatment; 14. Has known active TB, or suspected of active TB; 15. Has known active Hepatitis B or Hepatitis C is detected; 16. Has undergone major surgery within 30 days of Study Day 1. 17. Has received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 18. Is pregnant, breastfeeding within the projected duration of the study; 19. Has received live vaccine within 30 days prior to initial treatment, or planned to receive live vaccine during the study; 20. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 21. Has known severe hypersensitivity reactions to any component of drugs (level 3 or higher); 22. Has a history or current evidence of any condition that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate, ORR;Disease control rate, DCR;progression free survival, PFS;progression free survival 2, PFS2;3-year OS rate;Safety; | — |
Countries
China
Contacts
Public ContactZhehai Wang
Cancer Hospital Affiliated to Shandong first medical University
Outcome results
None listed