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The Landscape of Clinical Trials in Never-Smoker Non-Small-Cell Lung Cancer: Registered Evidence and Persistent Gaps

Raquel Ramos1,2, Carlos Sousa1,3, Nuno Vale1,2,4

  • 1PerMed Research Group, RISE-Health, Faculty of Medicine, University of Porto, 4200-319 Porto, Portugal.

Cancers
|February 27, 2026
PubMed

Insights

Lung cancer in never-smokers requires tailored clinical trials. Current evidence often comes from smoker studies, limiting personalized treatment for this distinct patient group.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Genomics

Background:

  • Lung cancer in never-smokers is a distinct entity with unique molecular profiles.
  • Therapeutic evidence is often extrapolated from trials dominated by smokers, potentially hindering optimization.
  • This patient population is growing and requires dedicated research.

Purpose of the Study:

  • To critically appraise clinical trials explicitly targeting lung cancer in never-smokers.
  • To analyze therapeutic strategies, molecular stratification, and trial design features.
  • To identify gaps and propose priorities for future research.

Main Methods:

  • Systematic review of clinical trials registered in ClinicalTrials.gov targeting never-smokers with lung cancer.
  • Analysis focused on therapeutic strategies, molecular enrichment, and trial design elements.
  • Evaluation of temporal trends in trial activity.

Main Results:

  • Clinical trials targeting never-smokers are limited and often lack prospective biomarker-guided designs.
  • Eligibility criteria, histological/genomic enrichment, and endpoints vary significantly across studies.
  • There's a need for more contemporary platform strategies tailored to this population.

Conclusions:

  • Dedicated clinical trials are crucial for never-smoker lung cancer to optimize personalized therapies.
  • Future trials should prioritize biomarker-driven designs and reflect the unique biology of this disease.
  • Accelerating evidence generation is key for improving treatment outcomes.
Keywords:
ClinicalTrials.govbiomarker-driven therapyclinical trialslung cancermolecular profilingnever-smokersnon-small cell lung cancerprecision oncologytargeted therapy

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