Systematic Review Maps Exponential Growth of Antibody-Drug Conjugate Trials in Lung Cancer
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Key Takeaway
Recognize the rapid growth of ADC trials in lung cancer but await late-phase results before changing practice.
This systematic review analyzed 466 antibody-drug conjugate (ADC) trials in lung cancer registered globally, spanning from 2001 to 2024. The review aimed to characterize the evolving clinical trial landscape, including trial numbers, geography, funding, phases, design, targets, linkers, payloads, and biomarkers.
Key findings reveal exponential growth in trial registrations, from a single trial in 2001 to 106 in 2024. Early-phase trials predominated, and 76 distinct targets were involved, with the top 15 accounting for 78.15% of trials. The most common targets were trophoblast cell surface antigen 2 (TROP2) at 18.07% and human epidermal growth factor receptor 2 (HER2) at 17.65%. Notably, 85.84% of trials featured biomarker assessments.
The authors acknowledge that the clinical trial landscape in lung cancer remains unclear, and they advocate for strengthened intercontinental collaboration and more late-phase trials to improve patient outcomes. Safety concerns, particularly the risk of interstitial lung disease (ILD) associated with ADCs, are noted.
For clinicians, this review highlights the rapid expansion of ADC research in lung cancer and the need for cautious interpretation of early-phase data. The predominance of early trials and the lack of comparative effectiveness data underscore the importance of awaiting results from ongoing late-phase studies before integrating these agents into routine practice.
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View Original Abstract ↓
Antibody–drug conjugates (ADCs) are emerging targeted therapies in cancer treatment. They selectively deliver cytotoxic payloads to tumor cells, improving efficacy and reducing toxicity. However, the clinical trial landscape in lung cancer remains unclear. This systematic review analyzes registered ADC trials in lung cancer comprehensively.
Trials were retrieved from the Trialtrove database from inception to July 1, 2025, focusing on ADC interventions in lung cancer. The inclusion criteria required complete ADC data, excluding observational studies or incomplete records. The analyses covered trial numbers, geography, funding, phases, design, targets, linkers, payloads, and biomarkers. This review follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
A total of 546 global trials were identified, of which 466 were included. The trial registrations grew exponentially from one in 2001 to 106 in 2024. Most trials were single-continent and industry-funded. Early phases predominated. A total of 76 targets were involved, with the top 15 (e.g., trophoblast cell surface antigen 2 (TROP2), 18.07%; human epidermal growth factor receptor 2 (HER2), 17.65%) accounting for 78.15%. The linkers were mainly cleavable protease-dependent. Payloads were dominated by DNA topoisomerase I inhibitors. Biomarkers were featured in 85.84% of trials.
This review highlights the rapid expansion and regional focus of ADC trials in lung cancer, driven by early phases and industry support. Diverse targets emphasize TROP2 and HER2, while biomarkers advance precision medicine from standard testing to personalized regimens. Novel targets and combinations enhance selectivity. Optimized linkers mitigate off-target risks, such as the risk of interstitial lung disease (ILD). This analysis offers researchers comprehensive insights and advocates for strengthened intercontinental collaboration and late-phase trials to improve patient outcomes.
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