Non-small-cell lung cancer
Conditions
Interventions
Experimental group:CT-707
Control group:Crizotinib
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion in this study: 1) Aged >= 18 years; 2) Gender: male and female; 3) ECOG PS score 0-2; 4) The estimated lifetime is no less than 12 weeks; 5) IIIB-IV stage of histological or cytological diagnosis is confirmed to be NSCLC according to the International Alliance against Cancer/United States Joint Committee on Cancer (UICC/AJCC) TNM staging standard ,8th edition and ALK positive is confirmed to be positive via central laboratory (screening period is subject to FISHVentana IHCRT-PCR or NGS testing by a non-central laboratory); 6) According to the RECIST V1.1(solid tumor), the subjects have at least one measurable lesion that have not been locally treated [measurable lesion with definite progression after local treatment; no bone metastasis alone or only central nervous system (CNS) metastasis as a measurable lesion]; 7) Subjects have previously received no more than one chemotherapy regimen with disease progression or toxic intolerance and have not received other relevant anti-tumor treatments, including ALK-TKI, immunotherapy, biotherapy (tumor vaccines, cytokines, or growth factors that control cancer); 8) No brain metastases; asymptomatic brain metastases; symptomatic brain metastases stabilized after treatment for more than 4 weeks and have stopped systemic hormone therapy for more than 2 weeks; 9) Subjects must have adequate organ functions (no supportive treatments have been received within 7 days prior to testing), defined as follows:Liver function: no liver metastasis, serum alanine aminotransferase (AST), alanine aminotransferase (ALT) = 1.0 e9/L; neutrophil absolute value (ANC) >= 1.0 x10^9/L; platelets (PLT)>= 75 x 10^9/L; hemoglobin (Hb) >= 80 g/L. Renal function: creatinine clearance >= 30 mL/min.Cardiac function: left ventricular ejection fraction (LVEF)>= 50%; 10) Other non-hematological toxicity associated with anti-tumor therapy must have been restored to level <= 2(except for debasement); 11) Serum pregnancy tests must confirmed to be negative for all women of reproductive age; male and female subjects with fertility must agree to remain abstinent or to use effective contraception for at least three months throughout the study period and after the last trial medication; 12) Subject consent and ability to comply with trial and follow-up procedure arrangements and sign informed consent.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria can not be included in this study: 1) Other malignancies occurring or currently occurring within five years with the exception of cured carcinoma in situ of the cervix, carcinoma in situ of the thyroid, skin cancer of non-melanoma and superficial bladder neoplasms; 2) Subjects who received other anti-tumor drugs within four weeks prior to the first medication, or who have been still within the five half-lives of the drug; 3) During the 3 months before medication, one of >= 2 level following conditions occurred: heart myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, cerebrovascular accidents, including transient ischemic attacks; 4) There is a persistent arrhythmia of more than level 2, any degree of poor atrial control vibrillar or QTc >500 ms; 5) Subjects have any history of active autoimmune disease or autoimmune disease requiring long-term use of large amounts of steroid hormones (excluding subjects who continuously use stable doses = level 3 peripheral neurological diseases; 7) With a history of extensive diffuse/double pulmonary interstitial fibrosis, or of 3-4 grade pulmonary interstitial fibrosis or interstitial pulmonary fibrosis, including pneumonia, allergic pneumonia, pulmonary embolism, interstitial lung disease, occlusive bronchiolitis, and pulmonary fibrosis, but excluding a history of previous localized radioactive pneumonia; 8) Gastrointestinal dysfunction or gastrointestinal diseases that may affect drug absorption (e.g. ulcerative diseases, uncontrollable nausea, vomiting, diarrhoea or poor absorption syndrome); 9) Subjects who are receiving any anticoagulant therapy with bleeding tendency, coagulation disorder or thrombus (excluding old thrombus); 10) Active hepatitis (hepatitis B: positive HBsAg or HBeAb and HBV-DNA >= 2000 IU/mL; hepatitis C: positive and HCV-RNA >= 1000 IU/mL), HIV positive, Treponema pallidum positive; 11) Subjects who underwent major surgery within four weeks prior to initial administration; 12) Subjects who received radical radiotherapy within 2 weeks prior to the first administration or who underwent palliative radiotherapy within 48 hours prior to the first administration; 13) Subjects who were receiving or were unable to stop using the following drugs at least 1 week prior to initial administration a. potent CYP3A inhibitors (including azanavir, clarithromycin, indenavir, itraconazole, ketoconazole, nefazone, nefenavir, litonavir, saquinavir, telymycin, acetaminophen, voriconazole, grapefruit, grapefruit juice and others) b. potent CYP3A inducers (including carbamazepine, phenytoin, carbamazepine, phenytoin, phenymetine, phenytoxapine) c. narrow-substrate (including afentanyl, cyclosporine, dihydroergol, ergometamine, fentanyl, pimozet, quinidine, sirolimus, tacrolimus and others); 14) Active virus, bacterial and fungal infections were present within 2 weeks prior to the first medication; 15) There has been a clear history of mental disorders; 16) According to the researcher's judgement, there are concomitant diseases that seriously endanger the safety of the subjects or affect the subjects to complete the study, which may increase the risk associated with the study, interfere with the interpretation of the results of the study. Or the researcher considers that the subjects are not suitable for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS by IRC; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS by investigator;OS;ORR;DOR;Intracal ORR;Intracal DOR;CNS progression time; | — |
Countries
China
Contacts
Public ContactLiyun Yang
Shouyao Holdings (Beijing) Co.Ltd.
Outcome results
None listed