Clinical trial · Observational
Clinical Outcomes and Immunotherapy in Lung Cancer With Pulmonary Fibrosis
Clinical Characteristics, Prognosis, and Immunotherapy Outcomes in Patients With Lung Cancer and Concomitant Pulmonary Fibrosis: An Observational Study Integrated With Single-Cell and Spatial Transcriptomics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Interstitial Lung Diseases | — | UNRESOLVED | — |
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Pulmonary Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| there is no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lung cancer without pulmonary fibrosis
- description
- patients with lung cancer without lung fibrosis
- interventionNames
- Other: there is no intervention
- label
- Lung cancer with pulmonary fibrosis
- interventionNames
- Other: there is no intervention
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- up to 36 months
Secondary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available