None listed
Conditions
Interventions
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
Sponsors
Centus Biotherapeutics Limited,
Eligibility
Sex/Gender
All
Inclusion 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
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
Countries
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
Public ContactRosmery Osorio
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed