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 CARBOPLATIN

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-027-16
• Date of registration: 09/12/2016
• Prospective Registration: Yes
• Primary sponsor: Centus Biotherapeutics Limited,
• Public title: 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 CARBOPLATIN
• Scientific title: 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 CARBOPLATIN
• Date of first enrolment: 01/01/2017
• Target sample size: 14
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=027-16
• Study type: Interventional
• Study design: This is a global multi-centre, double-blind, parallel, Phase 3 study designed to compare the efficacy and safety of FKB238 and EU-Avastin when used in combination with paclitaxel andreceptor tyrosine kinase (ALK) gene arrangement status (both are tested and known negative versus status unknown for either), geographical region, prior weight loss over the previous 6 months (< 5% yes versus no), and disease stage (advanced or recurrent). LA INFORMACION COMPLETA LA ENCONTRARA EN EL PROTOCOLO
• Phase: III

Countries of recruitment

Argentina, Belarus, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Croatia, France, Georgia, Germany, Greece, Hungary, Italy, Japan, Korea North, Korea South, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam

Contacts

• Name: Rosmery Ubaldo Osorio
• Affiliation: PAREXEL INTERNATIONAL (PERU) S.A.

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

-C349 Bronchus or lung, unspecified
Bronchus or lung, unspecified

Bronchus or lung, unspecified

C349

Intervention(s)

Concomitant Chemotherapy (Combination Drugs), Dose, and
Mode of Administration:
Paclitaxel, 200 mg/m2, intravenous (IV) infusion over 3 hours should be immediately followed by carboplatin, area under the
time curve 6.0, IV infusion over 15 to 30 minutes on Day 1.
Paclitaxel and carboplatin will be administered once every 21 days (± 3 days) for at least 4, and no more than 6 cycles. The number of
cycles is determined by patients’ need and the investigator’s assessment. LA INFORMACION COMPLETA LA ENCONTRARA EN EL PROTOCOLO

Source(s) of Monetary Support

Centus Biotherapeutics

Ethics review

Status: Approved
Approval date: 26/05/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 25/08/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 07/11/2016
Contact:

[e-mail]; [e-mail]

Hospital Nacional Carlos Alberto Seguin Escobedo - Arequipa

959383952

[e-mail]; [e-mail]

Results

• Results available: Yes
• Date Completed: 28/10/2019