Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: CT-P16: Induction Period: Patients will receive 15 mg/kg IV of CT-P16 every 3 weeks up to 6 cycles. Patients will also receive paclitaxel 200 mg/m2 IV and carboplatin area under the cur
Sponsors
CELLTRION Inc
PPD Pharmaceuticals India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Main Selection Criteria: Patients for stage IV or recurrent non-squamous non-small cell lung cancer (nsNSCLC) in this study will be considered for enrollment if they meet all of the inclusion criteria and none of the exclusion criteria. Each patient must meet all of the following criteria to be randomized in this study: 1. Patient (male or female) must be > 18 years of age. 2. Patient must have confirmed predominantly non-squamous non-small cell lung cancer (nsNSCLC) by hematoxylin and eosin staining or immunohistochemistry. 3. Patient must be diagnosed as recurrent disease or stage IV according to the American Joint Committee on Cancer (AJCC) Lung Cancer Staging 8th edition. Stage IV is defined as below: a. Separate tumor nodule(s) in a contralateral lobe, or b. Tumor with pleural or pericardial nodules, or c. Malignant pleural or pericardial effusion related to tumor, or d. Single or multiple extrathoracic metastases in a single organ or in multiple organs 4. Patient must have at least 1 measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Target lesions situated in a previously irradiated area are considered measurable if recurrence has been demonstrated in such lesions. a. Tumor lesions: = 10 mm in long axis by computerized tomography (CT) scan, or b. Malignant lymph nodes: = 15 mm in short axis by CT scan 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Oken et al., 1982). 6. Life expectancy > 6 months based on clinical judgement. 7. Negative result in both epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement which is confirmed by biopsy or cytology specimens. 8. Patient must have adequate organ function as follows. These tests must be performed within 14 days prior to Day 1 of Cycle 1. Bone marrow reserve: a. Hemoglobin = 9.0 g/dL, and b. Absolute neutrophil count = 1,500/mm3, and c. Platelet count = 100,000/mm3 Hepatic: a. Alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase = 3.0 × upper limit of normal (ULN) (= 5.0 × ULN with liver metastasis), and b. Total bilirubin = 1.5 × ULN Renal: a. Serum creatinine = 1.5 × ULN, and b. Creatinine clearance (CrCl) rate = 45 mL/min, and c. Urine dipstick for proteinuria 9. Patient and their partner of childbearing potential must agree to use acceptable birth control methods throughout the study and for 6 months after the last dose of assigned treatment (see Section 6.5.2.8). A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Male and female patients and their partners who have been surgically sterilized for less than 24 weeks prior to the date of informed consent must agree to use any medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential. 10. Patient has the ability to comprehend the full nature and purpose of the study, incl
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1.Patient who has predominantly squamous cell histology non-small cell lung cancer (NSCLC). If small cell elements are present, the patient is ineligible. 2.Patient who has clinically significant third-space fluid; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to Day 1 of Cycle 1. 3.Patient who has untreated CNS metastases or CNS metastasis with bleeding risk at investigator discretion and/or leptomeningeal disease.However, treated and clinically stable (asymptomatic, off steroids)brain metastases are allowed. 4.Patient who has invasion of major blood vessels.Patient with a tumor cavitation in the opinion of the investigator is likely to bleed will be excluded aswell. 5.Patient who has received previous anti-cancer systemic therapy including one or more of the following(s): a.Cytotoxic chemotherapy for metastatic nsNSCLC, b.Cytotoxic chemotherapy for non-metastatic nsNSCLC within 12 months prior to Day 1 of Cycle 1, c.Anti-neoplastic biological therapy, immunotherapy or targeted therapy, d.Bevacizumab (or a bevacizumab proposed biosimilar product). 6.Patient who has received previous surgical procedure including one or more of the following(s): a.Surgery for metastatic nsNSCLC, b.Surgery for non-metastatic nsNSCLC within 6months prior to Day1 of Cycle1, c.Open biopsy or open pleurodesis within 28days prior to Day1 of Cycle1, d.Core biopsy or other minor surgical procedure (e.g. placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy) within 14 days prior to Day 1 of Cycle 1. 7.Patient who has received previous anti-cancer radiotherapy including one or more of the following(s): a.Radiotherapy for metastatic nsNSCLC, but radiotherapy as part of the palliative therapy and/or treatment for CNS metastases completed at least 14days prior to Day1 of Cycle1 is allowed, b.Radiotherapy for non-metastatic nsNSCLC within 6months prior to Day1 of Cycle1, c.Any toxicity related with radiotherapy prior to Day1 of Cycle1. 8.Patient who has a medical history of disease including one or more of the following(s): a.Clinically significant allergic reactions such as asthma, urticaria, angio-oedema, and eczematous dermatitis, hypersensitivity to any component of carboplatin, paclitaxel, bevacizumab and Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanized antibodies. b.Cardiac, gastrointestinal, renal, hepatic, hematological (including pancytopenia, aplastic anemia or blood dyscrasia), metabolic (including known diabetes mellitus), autoimmune disease, or pulmonary diseases classed as significant in the opinion of the investigator. c.A known infection with hepatitis B (active or carrier of hepatitis B), hepatitis C, or infection with human immunodeficiency virus (HIV). However, a patient with past hepatitis B virus is allowed if resolved. d.New York Heart Association class2(Append 11.7)severe uncontrolled cardiac disease (unstable angina, clinically significant electrocardiogram [ECG] abnormalities, etc.), or myocardial infarction, within 6 months prior to Day 1 of Cycle 1. e.Malignancy or history of malignancy other than NSCLC in the past 5 years except adequately treated squamous or basal cel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by ORR up to Cycle 6 during the Induction Study PeriodTimepoint: During the Induction Study Period: every 3 weeks until 6 cycles and During the Maintenance Period: every 3 weeks until PD or intolerable toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate additional efficacy profiles including ORR during the Whole Study Period, response duration, time to progression (TTP), progression-free survival (PFS), and overall survival (OS) • To evaluate the pharmacokinetics (PK) of trough serum concentration (Ctrough) • To evaluate safety profile including immunogenicity • To evaluate quality of life (QoL)Timepoint: During the Induction Study Period: every 3 weeks until 6 cycles and During the Maintenance Period: every 3 weeks until PD or intolerable toxicity | — |
Countries
Belarus, Brazil, Bulgaria, Chile, Croatia, Georgia, Hungary, India, Japan, Malaysia, Mexico, Peru, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia, Thailand, Ukraine, Viet Nam
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed