A RANDOMISED, PARALLEL, DOUBLE BLINDED STUDY TO COMPARE THE EFFICACY AND SAFETY OF FKB238 TO AVASTIN® IN 1ST LINE TREATMENT FOR PATIENTS WITH ADVANCED/RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER IN COMBINATION OF PACLITAXEL AND CARBOPLATI

Centus Biotherapeutics Limited,0 个研究点目标入组 14 人开始时间: 2016年12月9日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•The following are the inclusion criteria:
•1. Patients aged 18 years or older
•2. Newly diagnosed advanced (stage IV) /recurrent NS-NSCLC for which they had not received any systemic anti-cancer
•therapy for metastatic disease, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
•3. Histologically or cytologically confirmed diagnosis of predominantly NS-NSCLC
•4. Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin for the treatment of advanced or
•recurrent NS-NSCLC
•5. Existence of at least 1 measurable lesion by response evaluation criteria (RECIST v1.1), defined as; at least one
•lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter
•(except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance
•imaging (MRI) which is suitable for accurate repeated measurements.
•6. Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
•LA INFORMACION COMPLETA LA ENCONTRARA EN EL PROTOCOLO

•The following are the exclusion criteria:
•1. Small cell lung cancer (SCLC) or combination SCLC andNSCLC. Squamous-cell tumours and mixed adenosquamous
•carcinomas of predominantly squamous nature
•2. Recurrence occurred within 12 months from the last dose of neoadjuvant/adjuvant therapy
•3. Any unresolved toxicities from prior systemic therapy (eg, adjuvant chemotherapy) greater than Common Terminology
•Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study drug with the exception of alopecia
•4. Evidence of a tumour that compresses or invades major blood vessels or tumour cavitation that in the opinion of the
•investigator is likely to bleed
•5. Known sensitising EGFR mutations (eg, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
•LA INFORMACION COMPLETA LA ENCONTRARA EN EL PROTOCOLO

发起方

Centus Biotherapeutics Limited,