Non-small cell lung cancer
Conditions
Interventions
Experimental group:Iruplinalkib monotherapy or combined with local radiotherapy
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form and voluntary participation in this study; 2.Histologically or cytologically confirmed advanced ALK-positive non-small cell lung cancer (NSCLC); 3.Clinical stage IIIB–IV; 4.Documented progression after prior treatment with a second-generation ALK tyrosine kinase inhibitor (TKI) (e.g., ensartinib, brigatinib, etc.); 5.Age >=18 and =3 months; 9.Adequate organ function as defined below (no blood products or hematopoietic growth factors within 2 weeks prior to initiation of study treatment): Hematology: Absolute neutrophil count (ANC) >=1.5×10^9/L; hemoglobin (Hb) >=90 g/L; platelets (PLT) >=90×10^9/L; serum albumin (ALB) >=2.8 g/dL. Biochemistry: Total bilirubin (TBIL) =50 mL/min (Cockcroft–Gault formula). Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) =50%; 10.Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours prior to the first dose of study drug and must agree to use effective contraception from the time of enrollment through 3 months after the last dose of iruplinalkib. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of iruplinalkib;
Exclusion criteria
Exclusion criteria: 1.Histologic or cytologic evidence of tumor components other than non-small cell carcinoma; 2.Pregnant or lactating women; 3.Documented hypersensitivity to ALK TKIs and/or their excipients; 4.Prior treatment with crizotinib; 5.Prior systemic antineoplastic therapy; 6.Any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enterocolitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism (subjects with hypothyroidism controlled by hormone replacement therapy may be enrolled); 7.Other malignancies within the past 5 years or concurrent malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 8.Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA >=10^4 copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of quantification of the assay); 9.Systemic corticosteroid therapy (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days prior to the first dose of study drug; inhaled or topical corticosteroids and adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease. 10.Active infection, unexplained fever >=38.5°C within 7 days prior to dosing, or white blood cell count >15×10^9/L at baseline. 11.Concurrent participation in another investigational drug clinical trial. 12.Concurrent treatment with other ALK TKIs. 13.Severe concomitant disease that, in the Investigator's opinion, would compromise patient safety or interfere with completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Safety;Overall survival period;Progression-free survival period; | — |
Countries
China
Contacts
Public ContactJiang Tingshu
Yantai Yuhuangding Hospital
Outcome results
None listed