Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC
- Conditions
- Non-Small Cell Lung CancerALK-positiveSAF-189s
- Registration Number
- NCT06569420
- Lead Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 275
Inclusion Criteria:<br><br> - Sufficiently understand the study and are willing to sign the informed consent form<br> (ICF);<br><br> - Male or female patients = 18;<br><br> - Histologically or cytologically confirmed diagnosis of local advanced (Stage<br> IIIB/IIIC) or metastatic (Stage IV) NSCLC;<br><br> - ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test. Sufficient<br> tumor tissue available to perform ALK IHC is required. Ventana IHC testing will be<br> performed at the designated central laboratory;<br><br> - Measurable disease by response evaluation criteria in solid tumors (RECIST) version<br> 1.1 (v1.1) prior to the administration of study treatment; Lesions that have<br> received radiation therapy cannot be considered as target lesions unless there is<br> confirmed progression of the lesion after radiation therapy;<br><br> - Participants with no prior systemic treatment for local advanced (Stage IIIB/IIIC<br> not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC;<br><br> - Eastern cooperative oncology group performance status (ECOG PS) of 0-2;<br><br> - Life expectancy of at least 12 weeks;<br><br> - Adequate organ and bone marrow function as documented by:Hematologic function:<br> absolute neutrophil count (ANC) =1.5 × 10^9/L; hemoglobin= 90 g/L; Platelet count =<br> 100 × 109/L;Serum total bilirubin = 1.5 × ULN (if the patient has Gilbert's<br> syndrome, = 3 × ULN and direct bilirubin = 1.5 × ULN);Aspartate aminotransferase<br> (AST) and alanine transaminase (ALT) = 2.5 × ULN (= 5 × ULN for patient with liver<br> metastases);Creatinine clearance (CrCL) = 50 mL/min (calculated by Cockcroft-Gault<br> equation);Baseline QTc =470 ms corrected by Fridericia fomula;Baseline LVEF=50%;<br><br> - For all females of childbearing potential (FCBP), a negative serum pregnancy test<br> result must be obtained within 7 days prior to starting study treatment, and agree<br> to use a highly effective method of contraception, during the treatment period and<br> for 3 months following the last dose of study drug.For men whose partners are<br> fertile women, agreement to remain abstinent or use a condom plus an additional<br> contraceptive method during the treatment period and for at least 3 months after the<br> last dose of study drug. Abstinence is acceptable only if it is in line with the<br> preferred and usual lifestyle of the participant. Periodic abstinence (e.g.,<br> calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not<br> acceptable methods of contraception. This protocol defines a FCBP as a sexually<br> mature woman who:1)has not undergone a hysterectomy or bilateral oophorectomy;2)has<br> not been naturally postmenopausal (amenorrhea following cancer therapy does not rule<br> out child-bearing potential) for at least 24 consecutive months (i.e., has had<br> menses at any time in the preceding 24 consecutive months).<br><br>Exclusion Criteria:<br><br> - Has had prior anti-cancer treatment with biological drugs, or other investigational<br> agents within 28 days; or received chemotherapy, TKI or targeted therapies within 14<br> days prior to enrollment; or based on the last administration within 5 half-life of<br> the drug (whichever is shorter);<br><br> - Patients with central nervous system (CNS) metastases requiring: 1)clinical local<br> intervention such as surgical excision, radiotherapy or other therapies (known brain<br> metastasis or other CNS metastasis that is either asymptomatic or symptomatic but<br> requiring no local interventions may qualify for the study per the investigator);<br> 2)patients requiring systemic treatment with corticosteroids and >10 mg/day<br> prednisone or equivalent; 3)requiring antiepileptic drug sustained treatment;<br><br> - Spinal cord meatstasis with potential risk of or symptomic spinal cord compression;<br><br> - National cancer institute common terminology criteria for adverse events (NCI CTCAE)<br> (version 5.0) Grade 2 or higher toxicities due to any prior therapy (e.g.,<br> chemotherapy, surgery or radiotherapy) (excluding alopecia)<br><br> - Patient has uncontrolled diabetes and intervented by insulin (patient with fasting<br> blood glucose levels <9.8 mmol/L under stable oral hypoglycemic medications allowed<br> to be enrolled);<br><br> - Has a history of acute pancreatitis within 1 year before enrollment, ;<br><br> - Patients have history of interstitial lung disease, drug-induced interstitial lung<br> disease or induced by radiation therapy and requring hormone therapy, or still<br> receiving medication or other clinical intervention, or currently having active<br> pulmonary interstitial lesions;<br><br> - The patients had uncontrollable amounts of pleural effusion, ascites, and<br> pericardial effusion.<br><br> - Patients with inability to swallow or with active digestive system disease or<br> underwent major GI surgery, which remarkably affect oral administration or<br> absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea and<br> vomiting, diarrhea, malabsorption syndrome, and small bowel resection);<br><br> - History of hypersensitivity to any of the additives in the SAF-189s and drug<br> formulation;<br><br> - History of hypersensitivity to any of the additives in the crizotinib and drug<br> formulation;<br><br> - Patients with clinically significant active bacterial, fungal or viral infections,<br> including hepatitis B virus surface antigen-positive and hepatitis B virus DNA over<br> 2000 IU/mL, positive for hepatitis C virus (HCV) antibody test; confirmed human<br> immunodeficiency virus (HIV) infection, and those who are unwilling to undergo HIV<br> testing; hepatitis B carriers are allowed to be enrolled;<br><br> - Patients have other malignant tumor history in 3 years or with other malignant<br> tumors simultaneously (excluding curatively treated in situ carcinoma of cervix<br> cancer, non-melanoma skin basal cell carcinoma, thyroid carcinoma in situ, and any<br> cured tumor which is considered to have no impact in progression-free survival (PFS)<br> or overall survival (OS) for the current NSCLC);<br><br> - Patients with cardiac function impairment or clinically significant heart diseases,<br> including congestive heart-failure New York Heart Association (NYHA) III or above,<br> arrhythmias (including but not limited to complete left bundle branch<br> Atrioventricular block complete and atrioventricular block second degree),<br> conduction abnormality requiring medication, severe coronary artery disease, heart<br> valve disease or myocardiopathy or uncontrolled hypertension;<br><br> - Patients who received major surgery within 3 weeks before enrollment or have not<br> adequately recovered from prior surgery. Major surgery is defined as Grade 3 or 4<br> surgery per Management Measures for Clinical Application of Medical Technology<br> implemented on May 1st, 2009 in China;<br><br> - Patients who have been received one of the following treatments: 1)strongly inhibits<br> or induces of CYP3A4, repaglinide (cytochrome [CYP]2C8 sensitive substrate) and<br> drugs metabolized via CYP3A4 enzyme within 1 week before enrollment; 2)medicines<br> which are known to cause QT prolongation or torsade de pointes;3)coumarin<br> anticoagulants within 1 week before enrollment (low molecular weight heparin is<br> permitted);4)illegal drugs;<br><br> - Pregnant or lactating: any subjects who experience pregnancy during the trial need<br> to withdraw from the study.<br
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) by IRC;Overall survival (OS);Progression-free survival (PFS) by INV;Objective Response Rate (ORR) by IRC and INV;Duration of response (DOR) by IRC and INV;to evaluate the C-ORR in patient with CNS metastases.;to assess the C-TTR in patient who have as CNS objective response;to assess the C-DOR in patient who have as CNS objective response.;to assess the C-TTP in patient who have as CNS objective response.;The time to CNS progression in ITT by IRC.;Incidence of adverse events.;Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score;Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire LC13 Score
- Secondary Outcome Measures
Name Time Method