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AGLAEAPHASE IIIPUBLISHED

REG-ONC-301

OncologyMetastatic Non-Small Cell Lung Cancer
prot-cvo7tudl43xo·Version 1.04·Fara Ashiru·Jan 15, 2026
Published ProtocolVersion 1.04
Comprehensive
75%Compliance
5,134Similar Trials
144Literature
19Guidelines
5Versions
Protocol Description
AI Generated

This comprehensive Phase III clinical trial evaluates the efficacy and safety of a novel combination immunotherapy regimen in patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy.

Study Objectives
AI Generated
Primary Objectives
  • Evaluate overall survival (OS) compared to standard of care
  • Assess progression-free survival (PFS) per RECIST 1.1
Secondary Objectives
  • Determine objective response rate (ORR)
  • Characterize safety and tolerability profile
Study Phase
Phase III
Target Enrollment
450 patients
Study Duration
48 months
Study Sites
75 sites globally
Target Population
AI Generated

Adults aged 18 years and older with histologically or cytologically confirmed metastatic non-small cell lung cancer (Stage IV) who have disease progression after platinum-based chemotherapy.

Key Inclusion Criteria
Age ≥18 years at time of informed consent
Histologically confirmed metastatic NSCLC (Stage IV)
ECOG Performance Status 0-1
Measurable disease per RECIST 1.1
Adequate organ function as defined by protocol
Key Exclusion Criteria
Prior treatment with PD-1/PD-L1 inhibitors
Active autoimmune disease requiring systemic treatment
Symptomatic CNS metastases
Known EGFR mutation or ALK rearrangement

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AGLAEA

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Protocol Generator — Study Objectives
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✓ Study Information
✓ Study Timeline
◉ Study Objectives
○ Study Population
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Study ObjectivesAI Generated

HYGEIA

Compliance Checker

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Compliance Checker — Protocol ABC-123
Compliance Analysis
94%
2
Critical
5
Warning
8
Info
Study objectives clearly defined
ICH E6
!
Safety monitoring needs expansion
FDA 21
Inclusion criteria complete
EMA
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Amendment Tracker — Version History
Protocol ABC-123v3.2 Current
v1.0
v2.0
v3.0
v3.2
⚡ Ripple Effect — 4 sections affected
Section 3.1: Study Objectives
Section 5.2: Eligibility Criteria
Section 7.4: Statistical Analysis
Section 9.1: Safety Monitoring
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PubMed
FDA
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Phase III Immunotherapy Study in NSCLC
A randomized, double-blind study evaluating...
PUBMEDOct 2025
Meta-Analysis: Checkpoint Inhibitors
Systematic review of 47 trials comparing...
FDA GUIDANCESep 2025
Immuno-Oncology Drug Development
Guidance for industry on clinical trial design...

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