The Problem We're Solving
Targeted therapies have transformed lung cancer treatment, but resistance is inevitable. When a cancer evolves to evade a therapy, physicians need rapid, real-world data on what mutations are driving that resistance and what might come next.
That insight doesn't come from traditional IND trials. It comes from lean, agile, biomarker-focused studies, which is just the kind ALCMI has been designing and running for two decades.
The ALCMI Resistance Trial Model
Our resistance mechanism trials are IND-exempt, observational biospecimen studies conducted with patients who have progressed on marketed targeted therapies. Here's what makes our model unique:
- IND-exempt. Less regulatory complexity, faster startup.
- Fully decentralized. Patients participate remotely from anywhere in the US. No clinic visits required.
- Sponsor-friendly. Medical affairs/medical marketing budget appropriate. Typically under $1M.
- Easy lift for sponsors. ALCMI manages everything, including protocol, IRB approval, site coordination, specimen logistics, data, and reporting.
- KOL-led. We partner with principal investigators at the world's top oncology institutions.
- Publication-ready. All trials are designed for peer-reviewed publication and conference presentation.
