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Clinical Trial CT-2025-103

Protocol Amendment 3 - Collaborative Review

In Review 5 reviewers assigned Due in 3 days

Original Protocol v2.1

Last modified: Feb 15, 2025 by Dr. Sarah Johnson

5.2 Inclusion Criteria

Subjects enrolled in this study must meet all of the following criteria:

  1. Male or female, aged 18-65 years.
  2. Histologically confirmed diagnosis of Stage III or IV non-small cell lung cancer (NSCLC).
  3. ECOG performance status 0-1.
  4. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL.
  5. Adequate renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min.
  6. Adequate hepatic function: AST and ALT ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN.
  7. Negative pregnancy test for women of childbearing potential.
  8. Willing and able to provide written informed consent.

5.3 Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from study participation:

  1. Prior treatment with any investigational drug within 30 days prior to first dose of study treatment.
  2. Known hypersensitivity to any component of the study drug formulation.
  3. Active central nervous system (CNS) metastases. Subjects with previously treated CNS metastases that are stable for at least 4 weeks prior to enrollment are eligible.
  4. Active autoimmune disease requiring systemic treatment within the past 3 months.
  5. History of interstitial lung disease or pneumonitis requiring treatment with steroids.
  6. Significant cardiovascular disease including unstable angina, myocardial infarction, or stroke within 6 months prior to enrollment.
Review Status 2 of 5 reviewers approved
Comments 7 comments, 3 unresolved
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