A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBio-Thera Solutions
About this trial
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Eligibility criteria
Qualifiers
Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);
Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;
Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;
Disqualifiers
Presence of EGFR gene mutation;
Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.
Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;
Trial design
Treatments tested in this trial
- BAT3306
- US-Keytruda®
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov