BR790 in Combination With Anlotinib in Adult Subjects With Advanced Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring BR790, Anlotinib, NSCLC, PTPN11, SHP2
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤75 years old. Subjects with histologically or cytologically confirmed locally advanced or relapsed metastatic driver negative (EGFR, ALK, ROS, etc.) advanced NSCLC,whose disease progressed after at least 2 previous standard therapies. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) . Exclusion Criteria: Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Has uncontrolled moderate to massive effusion. Central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day). Other kinds of malignancies within 5 years or for now. Has not enough organ functional reserve at baseline, which met at least one of the following criteria: ANC<1.5×10^9/L, PLT<100×10^9/L, Hb<100g/L; TBIL>1.5×ULN, ALT or AST>2.5×ULN (without liver metastases) , ALT or AST>5×ULN (with liver metastases);Cr >1.5×ULN, urine protein≥++,or confirmed 24h urine protein≥1.0g;INR >1.5×ULN, PT>1.5ULN or APTT >1.5×ULN. Previous use of other SHP2 inhibitors (such as TNO-155, JAB-3312, JAB-3068, RLY-1971, RMC-4630, etc.) Has used anlotinib before The first assessment of efficacy was PD, or occurred ≥grade 3 adverse reactions with antitumor angiogenesis small-molecule drugs (e.g. Apatinib, surufatinib, fruquintinib, etc.), or less than 6 months after the last antitumor vascular therapy. Has got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (5.0), alopecia and grade 2 peripheral neuropathy are not included.
Sites / Locations
Arms of the Study
Arm 1
Experimental
BR790+anlotinib
BR790 will be administered orally, variable dose on Day 1 of each 21-day cycle, Anlotinib will be administered as PO fixed dose on Day1-14 of each 21-day cycle