> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-bat3306-compared-with-keytruda-in-nsclc-26933af9-6da0-474f-a779-a0239e9f0922 > Record changed: 2026-10-13 # A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants NCT07180862 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) Lead sponsor Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) Start date 2025-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Title and summary **Summary** Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Short title** A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Official title** A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **First posted** 2025-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Registry last updated** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Primary completion date** 2027-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Start date** 2025-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Size and sites **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Planned participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Lead sponsor** Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Identifiers **Registry ID** NCT07180862 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **ClinicalTrials.gov ID** NCT07180862 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Outcomes ### Primary outcomes 1. PK equivalence Timeframe: Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days) To compare the pharmacokinetic (PK) similarity of BAT3306 versus US-Keytruda® as adjuvant therapy in participants with completely resected NSCLC：AUC0-τ, ss ### Secondary outcomes 1. PK equivalence Timeframe: Cycle 1，2，3，4，5，6，8，12，18（each cycle is 21 days） To evaluate the PK characteristics of BAT3306 and US-Keytruda® in participants with completely resected NSCLC：Cthough 2. immunogenicity equivalence Timeframe: Weeks 1, 4, 10, 16, 22，34，52 To evaluate the immunogenicity of BAT3306 and US-Keytruda® in participants with completely resected NSCLC:Anti-drug antibody (ADA) positive rate at Weeks 1, 4, 10, 16, 22，34，52 3. Vital signs Timeframe: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) Number of cases with abnormal vital signs results 4. Physical examination Timeframe: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) Number of cases with abnormal Physical examination results 5. Laboratory Examination Timeframe: The third and sixth weeks of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) Number of cases with abnormal Laboratory Examination results 6. Adverse event Timeframe: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0 7. DFS（Disease-free survival） Timeframe: Through study completion, No more than of 1 year the duration of the absence of tumor recurrence or metastasis as per the RECIST 1.1 criteria. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Participants must meet all of the following criteria: 1. Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF); 2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures; 3. Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided; ### Exclusion criteria - Participants who meet any of the following criteria will be excluded from the study: 1. Presence of EGFR gene mutation; 2. Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors; 3. Have previously received any of the following treatments: Have received > 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study. Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization. Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization. 4. Prior anti-tumor treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents. 5. Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization; Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Sites - Union Hospital Tongji Medical College Huazhong University of Science & TechnologyWuhan, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07180862) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Bio-Thera Solutions](https://trialight.com/data/company/bio-thera-solutions-f0083db2-9bf0-4f0c-af64-1650c0ec26d2.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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