A Phase 3 interventional study of BAT3306 and EU-Keytruda® in Carcinoma, Non-Small-Cell Lung, sponsored by Bio-Thera Solutions. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Bio-Thera Solutions · Phase 3, Interventional, and Treatment
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.
This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 162 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Bio-Thera Solutions is the lead sponsor of 54 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are eligible to be included in the study only if all the following criteria are met:
Exclusion Criteria:
Participant must be excluded from participating in the study if the participant:
Before the first dose of study intervention:
25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle
Drug: BAT3306 · Drug: Pemetrexed · Drug: Carboplatin
25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle
Drug: EU-Keytruda® · Drug: Pemetrexed · Drug: Carboplatin
25 mg/mL concentrate for solution for infusion. 200 mg on Day 1 of each 21-day cycle
Drug: US-Keytruda® · Drug: Pemetrexed · Drug: Carboplatin
One vial of 4 mL of concentrate contains 100 mg of BAT3306
Also known as: Pembrolizumab Injection
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Also known as: Pembrolizumab Injection
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Also known as: Pembrolizumab Injection
500 mg/m2 on Day 1 of each 21-day cycle of the study
Also known as: Pemetrexed Fresenius Kabi
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
Also known as: Carboplatin Kabi
clinical equivalence
To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLC. Confirmed best overall tumor response rate as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)
Time frame: Week 3,5,7,9,12,15,EOT
safety of BAT3306
The Investigator and any qualified designees are responsible for detecting, documenting, and reporting events that meet the definition of an AE or SAE and remain responsible for following up AE that are serious, considered related to the study intervention or the study, or that caused the participant to discontinue the study.
Time frame: From signed ICF to 90days after the last drug administration
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
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