Health Condition 1: C341- Malignant neoplasm of upper lobe,bronchus or lung
Conditions
Interventions
Intervention1: CT-P51: The CT-P51 drug product is a sterile liquid solution containing 100 mg of CT-P51 active substance. Each vial is designed to deliver a single dose of 100 mg pembrolizumab in 4 mL
Sponsors
CELLTRION, Inc.
Syneos Health India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients at least 18 years of age with histologically or cytologically confirmed metastatic nsNSCLC per the American Joint Committee on Cancer (AJCC) staging system with confirmed PD-L1 expression level in whom EGFR mutation and ALK rearrangement-directed therapy is not indicated will be considered for enrollment if they meet all the inclusion and none of the exclusion criteria.Patient must agree to use acceptable birth control methods throughout the study and after the last dose of study treatment as described below: a) Female patients of childbearing potential must agree to use acceptable birth control methods throughout the study and for 4 months after the last dose of CT-P51 or Keytruda, 6 months after the last dose of pemetrexed, and for 14 months after the last dose of cisplatin. b) Male patients with a female partner of childbearing potential must agree to use acceptable birth control methods throughout the study and for 4 months after the last dose of CT-P51 or Keytruda, 3 months after the last dose of pemetrexed, and for 11 months after the last dose of cisplatin. c) A man or woman is of childbearing potential if, in the opinion of the investigator, they are biologically capable of having children and are 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 medically acceptable methods of contraception. Menopausal females must have experienced their last menses more than 1 year prior to the date of informed consent to be classified as not of childbearing potential. 12. Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and/or written instructions, and to comply with the requirements of the entire study. 13. Patient and/or their legally authorized representative must be informed and given ample time and opportunity to read the ICF, understand the nature and purpose of this study, and sign the ICF before any study-specific procedures.
Exclusion criteria
Exclusion criteria: Patient has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible. Patient has carcinomatous meningitis or active CNS metastases. Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first study drug administration. Also refer to exclusion criteria in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The therapeutic equivalence of CT-P51 and Keytruda will be demonstrated in terms of ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in the intent-to-treat (ITT) set.Timepoint: CT-P51 200 mg and pemetrexed 500 mg/m2 will be administered as an IV infusion on Day 1 of each cycle every 3 weeks until unacceptable toxicity, PD, or a maximum of 18 cycles, whichever occurs first. Cisplatin 75 mg/m2 or carboplatin AUC 5 will also be administered as an IV infusion on Day 1 of each cycle and be repeated every 3 weeks for up to 4 cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate additional efficacy, immunogenicity, safety profile, PK profile profiles.Timepoint: ORR based on the confirmed BOR during the Main Treatment Period and the whole study period, and TTE analysis during the Main Treatment Period and the whole study period based on tumor assessments according to RECIST version 1.1 in the ITT and PP sets. Incidence and titer levels of anti-pembrolizumab antibody and incidence of neutralizing antibody (if applicable) in the safety set. Occurrence and severity of TEAEs in the safety set Descriptive characterization of lab parameters and other safety evaluations in the safety set. Ctrough at each cycle with serum samples collected for PK analyses in the PK set | — |
Countries
Argentina, Bosnia and Herzegovina, Brazil, Chile, Croatia, Georgia, Greece, India, Lithuania, Macedonia, Malaysia, Mexico, Peru, Poland, Romania, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine, United States of America, Viet Nam
Contacts
Public ContactAtaur Rahman
Syneos Health India Private Limited
Outcome results
None listed