Navigating Oncology Clinical Trials: A Patient & Clinician Guide

Step 1: Gather Your Exact Molecular Biomarker Profile

Modern clinical trials are biomarker-driven rather than organ-only. Ensure you have your full pathology report, Next-Generation Sequencing (NGS) panel, and immunohistochemistry (IHC) results (e.g., KRAS G12C, HER2 IHC score, MSI status, PD-L1 TPS).

Step 2: Understand Trial Phases

• Phase 1: First-in-human or dose-escalation trials evaluating safety, pharmacokinetics, and maximum tolerated dose.
• Phase 2: Evaluates efficacy (overall response rate ORR, progression-free survival PFS) in a specific biomarker subset.
• Phase 3: Large randomized controlled trials comparing the investigational therapy against the current standard-of-care.

Step 3: Accessing Expanded Access / Compassionate Use

If you do not qualify for an ongoing trial or live too far from an academic center, your oncologist can submit an FDA Expanded Access (Single-Patient IND) request to obtain investigational drugs directly from the pharmaceutical sponsor.