Patients with ALK-positive non-small cell lung cancer of clinical stage IIIB-IV
Conditions
Interventions
Iruplinalkib:Iruplinalkib
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form and voluntarily joined this study; 2. Histologically or cytologically confirmed advanced ALK-positive non-small cell lung cancer; 3. The clinical stage is stage IIIB-IV; 4. Progression after prior treatment with second-generation ALK TKI (e.g., ensartinib, brigatinib, etc.):; 5. Age 18 -75 years old, male or female; 6. All subjects must have at least 1 measurable extracranial target lesion according to RECIST v1.1 and have not been previously irradiated. Central nervous system metastases are allowed in the following cases: a. Asymptomatic: not currently requiring corticosteroid therapy, or taking a stable or decreasing dose of 10 mg QD prednisone or equivalent; b. Prior diagnosis and treatment have been completed and have fully recovered from an acute response to radiation therapy or surgery prior to enrollment, and if corticosteroid therapy for these metastases has been discontinued for at least 4 weeks and neurologically stable; 7. ECOG PS 0-2; 8. Life expectation>=3 months; 9. Vital organ function meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks prior to starting study treatment): ? Routine blood examination must be satisfactory: Absolute neutrophil count (ANC) >=1.5×10^9/L; Hemoglobin (HB) >= 90g/L; Platelets (PLT) >= 90×10^9/L; Serum albumin (ALB)>= 2.8 g/dL. Biochemical tests must meet the following criteria: Total bilirubin (TBIL) = 50ml/min (Cockcroft-Gault formula); Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) =50%. 10. Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug and be proven negative, and willing to use an effective method of contraception during the trial period until 3 months after the last dose of Iruak; For male subjects whose partner is a woman of childbearing age, an effective method of contraception should be used for the duration of the trial and for 3 months after the last dose of Iruplinalkib.
Exclusion criteria
Exclusion criteria: 1. Presence of other components in tissue or cell pathology other than non-small cell carcinoma; 2. Pregnant women; 3. Those who have confirmed allergy to ALK TKI and/or its excipients; 4. Prior treatment with crizotinib; 5. Previous treatment with other systemic anti-tumor therapy; 6. Have any active autoimmune disease or have a history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); 7. Other malignancies within the past 5 years or concomitant (with the exception of curative basal cell carcinoma of the skin and carcinoma in situ of the cervix); 8. Has congenital or acquired immunodeficiency (e.g., HIV-infected), active hepatitis B (HBV-DNA>=10^4 copies/mL), or hepatitis C (positive for hepatitis C antibodies, and HCV-RNA above the lower limit of detection of the analytical method); 9. Subjects who require systemic treatment with corticosteroids (>10mg/day, efficacy dose of prednisone) or other immunosuppressants within 14 days prior to the first use of study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at a dose of >10 mg/day, a prednisone efficacy dose are permitted; 10. The patient has an active infection, has an unexplained fever >=38.5°C, or a baseline white blood cell count > 15×10^9/L; 11. Patients who are participating in clinical trials of other drugs; 12. Patients who have received other ALK TKIs at the same time; 13. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objectibe Response Rate; | — |
Countries
China
Contacts
Public ContactJinZhou
Sichuan Cancer Hospital
Outcome results
None listed