Non-Small Cell Lung Cancer CRO
Developing new therapies for non-small cell lung cancer
Over the last 10 years, non-small cell lung cancer (NSCLC) clinical research has evolved from a focus on platinum-based chemotherapy to personalized medicine. Types and sizes of target patient populations have reduced dramatically—costs and risks have not.
The sheer pace of advances in caring for NSCLC patients all but guarantees that diagnostic and treatment dynamics will change materially as new drugs are being developed. Adapting to these shifts in clinical practice can be daunting and frustrating for even experienced and well-capitalized companies.
Proven expertise in NSCLC clinical trials
We have a strong track record in NSCLC clinical research, built on long-standing relationships with principal investigators and trial sites. Our differentiated team combines deep therapeutic knowledge—from clinical KOLs to hands-on operational excellence as a CRO—and has successfully managed complex global oncology studies across early and late phases, including registrational trials.
Our in-depth experience in non-small cell lung cancer clinical studies since 2020 positions us as a leading lung cancer CRO:
59+
NSCLC studies
11,000+
patients
3,000+
sites
Why choose Syneos Health for your lung cancer clinical trial?
We offer measurable experience across NSCLC therapies—from immuno-oncology and targeted treatments to emerging modalities like ADCs. Our end-to-end capabilities span early development through launch, including:
- Early phase leadership in dose optimization and Project Optimus-aligned strategies
- Adaptive trial designs and biomarker-driven cohorts to accelerate proof-of-concept
- Boutique CRO model with handpicked study teams for biotech sponsors
- Global scale-up from local phase I to multi-regional phase III trials
- Catalyst sites with proven NSCLC experience for speed, quality and predictability
- StudyKIK-powered recruitment for faster, more inclusive enrollment
- Integrated commercialization capabilities including market analysis, payer insights and target product profile design
Get in touch
Meet your NSCLC experts
Wael Harb, MD
VP, Medical Management
Jozsef Palatka, MD
VP, Medical Management
Marianne Wolfsteiner, MD
Executive Medical Director, Medical Management
Ewelina Mazur, MD, PhD
Executive Medical Director, Medical Management
Wayne Waterfield
Managing Director, Consulting
Keith Kelly
Managing Director, Consulting
Carina Gaspar
Sr. Medical Director, Medical Management
Immunotherapy has transformed the treatment landscape for NSCLC, offering a mechanism that activates the body’s immune system to target and destroy cancer cells. This means greater access to therapies with durable responses and favorable safety profiles, especially for patients without actionable mutations. Immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1) are now standard of care, and combination strategies with chemotherapy or anti-inflammatory agents are expanding efficacy across broader populations. These innovations support trial designs that prioritize long-term benefit, patient-centric endpoints and biomarker-driven enrollment.
mRNA vaccines are emerging as a powerful tool in oncology, with over 120 active trials exploring their potential to personalize cancer therapy. This modality offers rapid development timelines, tumor-specific targeting and synergy with existing immunotherapies. In lung cancer, early phase trials show promising immune activation and tolerability, while combination approaches with checkpoint inhibitors are enhancing outcomes. The platform’s flexibility enables both individualized and off-the-shelf solutions, positioning mRNA vaccines as a strategic asset in next-generation cancer pipelines.
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