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

Not Applicable

• Conditions: -C349 Bronchus or lung, unspecified; Bronchus or lung, unspecified; C349

• Registration Number: PER-027-16
• Lead Sponsor: Centus Biotherapeutics Limited,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Study Completion: 2019-10-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified