A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants

NCT07180862
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
160
clinicaltrials.gov
Lead sponsor
Bio-Thera Solutions
clinicaltrials.gov
Start date
2025-10-14
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Summary
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
clinicaltrials.gov
Short title
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-11-30
clinicaltrials.gov
First posted
2025-09-18
clinicaltrials.gov
Registry last updated
2026-07-17
clinicaltrials.gov
Primary completion date
2027-02-28
clinicaltrials.gov
Start date
2025-10-14
clinicaltrials.gov

Participants
160
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
160
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Randomisation ratio
1:1
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Bio-Thera Solutions
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07180862
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07180862
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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;

  • 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
clinicaltrials.gov

  • Union Hospital Tongji Medical College Huazhong University of Science & TechnologyWuhan, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)