Non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:Received 2 courses of induction therapy with SBRT and ivoneximab (AK112) in combination with platinum-doublet regimen, followed by standard concurrent chemoradiotherapy (chest radio
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. ECOG physical condition: 0-1 point; 3. Expected survival of more than 3 months; 4. Patients with locally advanced/irrecisable stage IIIA-C NSCLC diagnosed by histopathological or cytological examination based on AJCC 9th edition staging at the time of initial diagnosis; 5. Not receiving any anti-tumor therapy; 6. No known susceptible EGFR/ALK/ROS1 gene mutations; 7. Must have at least one measurable lesion as the target lesion according to the RECIST criteria 8. Good organ function prior to the first dose of study drug =1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >=90g/L b. International normalized ratio (INR) or prothrombin time PT))) = 25 g/L ((2.5 g/dL); ); g. Serum creatinine: Serum creatinine 50 mL/min; 9. Obtain informed consent signed by the patient or his/her legal representativeObtain the informed consent signed by the patient or his/her legal representative, and follow the study protocol and follow-up process; Adherence to the study protocol and follow-up process; 10. Patients of childbearing potential must be willing to continue to use highly effective contraception for the duration of the study, and for a period of > = 120 days after the last dose of ivoneximab (patients of childbearing potential must be willing to use the last dose of ivonexib (AK112)). Continue to use highly effective contraception.
Exclusion criteria
Exclusion criteria: 1. Pathological types of mixed small cell and non-small cell lung cancer; 2. Patient carries a known EGFR/ALK/ROS1 mutation; 3. Patient has received approved systemic anticancer therapy or systemic immune modulators (including but not limited to interferon, interleukin-2 and tumor necrosis factor) within 4 weeks prior to the first dose; 4. Vaccination with live or live attenuated vaccine within 4 weeks prior to enrollment, or anticipated need for live or live attenuated vaccine during the study or within 5 months after the last dose of ivoximab; 5. Patients who are allergic to ivoneximab (AK112) or any ingredient in the formulation, or any ingredient of the container; 6. Patients with untreated chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA >=500 IU/mL, patients with active hepatitis C: - Patients with inactive HBsAg carriers, patients with active HBV infection (HBV DNA 2 weeks prior to enrollment and continued treatment for 6 months after discontinuation of study drug therapy. 7. Active autoimmune disease requiring systemic therapy, active autoimmune disease requiring systemic treatment as assessed by the investigator as having an impact on the study treatment, patients who are considered by the investigator to have an impact on the study treatment; 8. Require use of corticosteroids (prednisone or equivalent) prior to the first dose of study drug prior to the first dose of study drug 10 mg/day) or other immunosuppressive drugs for systemic therapy, any condition of systemic treatment with or other immunosuppressive drugs as assessed by the investigator, patients who are considered by the investigator to have an impact on the study treatment; 9. Severe chronic or active infection (including tuberculosis infection, etc.) requiring antibacterial, antifungal or antiviral systemic therapy within 14 days before the first dose of the study drug; 10. Prior allogeneic stem cell transplantation or organ transplantation; 11. Meets the criteria for any of the following cardiovascular risk factors:Meets the criteria for any of the following cardiovascular risk factors: a. Presence of cardiogenic chest pain grade 2 <=6 months prior to the first dose of study drug; f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related toxicities;Progression Free Survival;Disease control rate at week 7 of treatment or before concurrent chemoradiotherapy (cCRT);Time to Death or Distant metastasis;Overall Survival;12-month progression-free survival (PFS) rate; | — |
Countries
China
Contacts
Public ContactXu Yaping/Ren Shengxiang
Shanghai Pulmonary Hospital
Outcome results
None listed