A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelltrion
About this trial
The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stage IV, non squamous NSCLC
Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
Have at least 1 measurable lesion per RECIST version 1.1
Disqualifiers
Have predominantly squamous cell histology NSCLC.
Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin
Trial design
Design model
Parallel
Treatments tested in this trial
CT-P51
DrugCT-P51 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks
EU-approved Keytruda
DrugKeytruda 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks
Treatment groups
606 Participants
are divided into 2 treatment groupsGroup A: CT-P51Experimental treatment 1 intervention
Group B: EU-approved KeytrudaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 34 weeks Source ClinicalTrials.gov