NCT07396467Active, not recruiting
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 · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 1 Feb 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07396467
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Nov 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The anatomical location of the lung cancer lesion does not overlap with the ILD-involved area.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.