Muco-active Agent Use and Clinical Outcomes After Lung Cancer Diagnosis in Chronic Obstructive Pulmonary Disease

Summary

The Target Trial Emulation of Muco-active Agent Use and Clinical Outcomes After Lung Cancer Diagnosis Among Patients With Chronic Obstructive Pulmonary Disease (TAME-CLC) study is a retrospective observational cohort study using existing real-world data from the Korean Cancer Data Center (K-CURE) database to evaluate whether use of muco-active agents is associated with clinical outcomes after lung cancer diagnosis among adults with chronic obstructive pulmonary disease (COPD) and localized-stage lung cancer.

The investigators will not assign any treatment or medication. Instead, the study will emulate a hypothetical target trial using routinely collected retrospective data. Eligible patients will be adults aged 40 to less than 80 years who have COPD before lung cancer diagnosis and meet prespecified diagnostic and treatment-based criteria. Patients will be classified according to muco-active agent treatment strategies based on prescription records after the first lung cancer diagnosis.

The emulated treatment strategy is use of any muco-active agent within a prespecified grace period after lung cancer diagnosis. The comparator strategy is no muco-active agent use during the same grace period. Muco-active agents include mucolytics, mucoregulators, expectorants, and mucokinetics, such as N-acetylcysteine, erdosteine, carbocysteine, guaifenesin, ivy-leaf extract, ambroxol, and bromhexine.

The primary outcome is time to moderate-to-severe COPD exacerbation after lung cancer diagnosis. Secondary outcomes include all-cause mortality, cancer-related mortality, and respiratory disease-related mortality. A clone-censoring-weighting approach will be used within a target trial emulation framework to estimate the modified intention-to-treat effect of muco-active agent use while adjusting for measured baseline differences between treatment strategies.

Conditions

• Lung Cancer (Diagnosis)
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Muco-active agents

Exposure is defined as initiation of any prespecified muco-active agent during the 4-week grace period, with alternative 2-, 6-, and 8-week grace periods evaluated in sensitivity analyses, after the first diagnosis of localized-stage lung cancer. Drug exposure will be identified using prescription records from the Korean Cancer Data Center (K-CURE) database. Patients receiving muco-active agents during the 12-week washout period before lung cancer diagnosis will be excluded to emulate a new-user target trial. Exposure classification follows the predefined treatment strategies specified in the target trial protocol.

OTHER

No muco-active agent use

Comparator exposure strategy defined as no prescription, medication order, or dispensing record for a prespecified muco-active agent during the exposure assessment window after the index date.

Sponsors & Collaborators

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Seoul National University

  lead OTHER

Principal Investigators

• Hyun Woo Lee, MD, PhD · Department of Pulmonary and Critical Care Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine

• Jiyu Sun · Integrated Biostatistics Branch, Division of Cancer Data Science, National Cancer Center

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• South Korea

Study Locations