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

Summary

Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment

Eligibility

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 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;

Conditions3

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