Clinical Trial CT-2025-103
Protocol Amendment 3 - Collaborative Review
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:
- Male or female, aged 18-65 years.
- Histologically confirmed diagnosis of Stage III or IV non-small cell lung cancer (NSCLC).
- ECOG performance status 0-1.
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL.
- Adequate renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min.
- Adequate hepatic function: AST and ALT ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN.
- Negative pregnancy test for women of childbearing potential.
- 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:
- Prior treatment with any investigational drug within 30 days prior to first dose of study treatment.
- Known hypersensitivity to any component of the study drug formulation.
- 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.
- Active autoimmune disease requiring systemic treatment within the past 3 months.
- History of interstitial lung disease or pneumonitis requiring treatment with steroids.
- Significant cardiovascular disease including unstable angina, myocardial infarction, or stroke within 6 months prior to enrollment.
Annotations & Comments
AI Insights
Key Changes Detected:
- Age range expanded (65→75 years)
- Lowered bone marrow function requirements
- Increased liver function parameter limits
- Added time constraint to lung disease exclusion
- Added new inclusion and exclusion criteria
Potential Implications:
- Broader patient eligibility criteria
- May increase enrollment by 15-20%
- Possible increase in adverse event rates
Regulatory Considerations:
- May require IRB reapproval
- Reconsent needed for existing patients
Dr. Rachel Brown
Apr 19, 2025 10:32 AM
Are we sure about lowering the platelet count requirement to 75? This seems quite low for this patient population.
Dr. Michael Chen
Apr 19, 2025 11:15 AM
The amendment aims to be more inclusive. Our safety monitoring will be increased for patients with lower counts, and we'll add weekly monitoring for the first cycle.
Dr. Thomas Johnson
Apr 19, 2025 2:45 PM
We should document the rationale for these changes in the amendment justification section. This will help with regulatory review.