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Active, not recruiting Observational

Clinical Outcomes and Immunotherapy in Lung Cancer With Pulmonary Fibrosis

NCT07396467 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-11-01
Last updated
2026-03-17

Condition(s) studied

Lung Cancer (Diagnosis)Pulmonary FibrosisInterstitial Lung Diseases

Investigational drug(s) / intervention(s)

there is no intervention

there is no intervention: there is no intervention

Study summary

This retrospective observational study evaluates immune checkpoint inhibitor (ICI)-related outcomes in lung cancer patients with concomitant pulmonary fibrosis/interstitial lung disease (ILD) and determines how fibrosis/ILD modifies immunotherapy effectiveness and safety. The study characterizes the clinical, radiographic, pathological, and molecular features of lung cancer with ILD and examines their associations with ICI response and survival. A comparator cohort of lung cancer patients without radiographic ILD from the same institution and time period is included to compare ICI effectiveness (e.g., response and survival outcomes) and pulmonary toxicity signals, including pneumonitis and acute ILD exacerbation.

In a translational sub-study, archived lung tumor specimens undergo single-cell and spatial transcriptomic profiling to identify fibrosis-associated tumor-microenvironment programs that may underlie differential immunotherapy outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Pathologically confirmed lung cancer. Interstitial lung disease identified on chest imaging (e.g., high-resolution computed tomography). Diagnosed and treated at Jiangsu Provincial People's Hospital between January 2019 and September 2025. Exclusion Criteria: * The anatomical location of the lung cancer lesion does not overlap with the ILD-involved area.

Primary outcome measure(s)

  • Overall survival (OS) — up to 36 months

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07396467 on ClinicalTrials.gov ↗ ← All trials in China