A Phase 3 clinical trial (NCT06280196) evaluating Pembrolizumab (Keytruda) as a comparator arm in non-small cell lung cancer has been terminated. The study, which had an enrollment of 162 participants, was designed to compare BAT3306 plus chemotherapy with Keytruda.
Background
Pembrolizumab (Keytruda) is an established immunotherapy. This trial involved participants with non-small-cell lung carcinoma, a common type of lung cancer.
Trial design
The trial, identified as NCT06280196, was a Phase 3 study with an enrollment of 162 participants. It focused on individuals diagnosed with non-small-cell lung carcinoma. The study's brief title was "A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC." Its primary objective, as stated in the brief summary, was to compare the pairwise pharmacokinetic (PK) similarities between BAT3306, EU-Keytruda, and US-Keytruda. All investigational agents were planned to be administered with pemetrexed and carboplatin.
What this means
The termination of this Phase 3 trial means that the planned evaluation of pharmacokinetic similarities, efficacy, and safety between BAT3306 plus chemotherapy and Pembrolizumab (Keytruda) in participants with intravenous non-small cell lung carcinoma will not proceed as originally intended through this study. This impacts the availability of comparative data that could have informed the development of BAT3306 against the established immunotherapy Keytruda in this patient population.
Source
The information regarding this trial's status was sourced from ClinicalTrials.gov, a public database of clinical studies. The entry for study NCT06280196, titled "A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC," indicates an expected primary completion date of 2025-07-30, with an overall status of TERMINATED. The data is available on clinicaltrials.gov.