Advanced non-small cell lung cancer
Conditions
Interventions
Experimental Group:Camrelizumab plus chemotherapy and Ivarmacitinib
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 75 years old, gender not restricted; 2. ECOG score: 0 - 1; 3. Estimated survival period: >= 3 months; 4. Histologically or cytologically confirmed, and for locally advanced (stage IIIB/IIIc) or metastatic (stage IV) NSCLC that is not suitable for radical surgery and/or radical radiotherapy (regardless of whether concurrent or sequential chemotherapy is received) [according to the International Union for Cancer Control and the American Joint Committee on Cancer (AJCC) 9th edition lung cancer TNM staging]; 5. According to the RECIST 1.1 standard, there must be at least one measurable lesion; 6. Before enrollment, no systemic anti-tumor treatment for advanced/metastatic NSCLC has been received. Chemotherapy and/or radiotherapy can be used as part of neoadjuvant/adjuvant treatment as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease; 7. No known driver gene alterations such as EGFR, ALK, ROS1, etc. For squamous NSCLC patients with a smoking history, if the previous EGFR and ALK gene status is unknown, no corresponding tests are required before enrolling in this study and it is considered negative; 8. Normal main laboratory tests; 9. Female participants of childbearing age must undergo a serum pregnancy test 3 days before starting the study medication, and the result must be negative. They are also willing to use a medically approved highly effective contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 180 days after the last administration of the study medication; For male participants whose partner is of childbearing age, surgical sterilization should be performed or they should agree to use an effective method of contraception during the study period and within 180 days after the last administration of the study medication; 10. Study participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer components confirmed by histology; 2. Known sensitive EGFR mutation /ALK rearrangement /ROS1 fusion; 3. Confirm symptomatic, untreated, or actively progressing central nervous system (CNS) metastases by CT or MRI assessment during screening and before radiologic imaging assessment. However, asymptomatic patients with stable CNS lesions after local treatment were also eligible as long as all the following conditions were met: 1) =2 weeks of intravenous antibiotic treatment, bacteremia, severe pneumonia, etc.) or any active infection within 4 weeks before the first dose of medication; 11. Patients with active pulmonary tuberculosis infection within 1 year before the first dose; 12. Study participants with any active, known, or suspected autoimmune disease or history of autoimmune disease who were in stable condition and did not require systemic immunosuppressive therapy were allowed to be enrolled; 13. Patients who are HBsAg positive and have an HBV DNA test value above the upper limit of the normal range (1000 copies /mL or 500 IU/mL), are HCV positive (HCV RNA or HCV Ab tests suggest acute or chronic infection), or have active hepatitis B or C, a known history of HIV positivity, or known AIDS; 14. Patients who underwent major surgery within 4 weeks before the first medication; Patients who underwent minor traumatic surgery (catheterization, biopsy, bronchoscopy) within 7 days before the first administration; Patients receiving non-thoracic radiotherapy with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Objective response rate;Overall survival period;Disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactPanwen Tian
West China Hospital of Sichuan University
Outcome results
None listed