Lung Cancer (Diagnosis)IPF-LC-IONCT07396467
Clinical Outcomes and Immunotherapy in Lung Cancer With Pulmonary Fibrosis
An observational study of Lung Cancer (Diagnosis) and Pulmonary Fibrosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Cancer (Diagnosis), Pulmonary Fibrosis, Interstitial Lung Diseases
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective, single-center observational cohort study of patients with pathologically confirmed lung cancer and imaging-confirmed interstitial lung disease (ILD) diagnosed at Jiangsu Provincial People's Hospital between January 2019 and September 2025. Eligible cases will be identified from hospital information systems and clinical records. Clinical characteristics, laboratory results, imaging, pathology and molecular reports will be extracted from Hospital Information System (HIS), Laboratory Information System (LIS), and Picture Archiving and Communication System (PACS) databases. Available tumor tissue specimens (bronchoscopic biopsy, CT-guided lung biopsy, or surgically resected lung tissue) will be collected for spatial transcriptomics analysis. Patients whose tumor location does not overlap with ILD-involved areas will be excluded.
Who may be able to join
- 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.
Who cannot join
- The anatomical location of the lung cancer lesion does not overlap with the ILD-involved area.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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
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.
Read the detailed description
Lung cancer with concomitant pulmonary fibrosis/interstitial lung disease (ILD) represents a clinically challenging population in which immune checkpoint inhibitor (ICI) treatment may be influenced by baseline lung vulnerability and a distinct tumor immune microenvironment. This single-center retrospective observational cohort study evaluates how fibrosis/ILD status and related clinical features are associated with immunotherapy use, effectiveness, and safety.
Patients with pathologically confirmed lung cancer and radiographic evidence of pulmonary fibrosis/ILD diagnosed and treated at Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University) are identified. A comparator cohort of lung cancer patients without radiographic ILD from the same institution and time period is assembled to enable direct comparisons of immunotherapy outcomes. Baseline demographics, smoking history, comorbidities, pulmonary function and imaging features (when available), tumor histology and stage, relevant laboratory indices, and molecular testing results are collected and analyzed. Associations between these variables and ICI exposure or clinical outcomes are evaluated.
Primary analyses focus on immunotherapy-related endpoints, including real-world measures of ICI effectiveness such as objective response and survival outcomes captured in routine clinical care. Safety analyses include ILD-relevant outcomes such as immune-related pneumonitis, acute exacerbation of underlying ILD, treatment interruption or discontinuation, and other clinically significant pulmonary adverse events. Comparative analyses evaluate whether patients with lung cancer and fibrosis/ILD experience different ICI effectiveness or higher pulmonary toxicity risk compared with patients without ILD. Additional analyses explore which clinical, radiographic, pathological, or molecular features within the ILD cohort are associated with favorable or unfavorable immunotherapy outcomes.
To investigate potential mechanisms underlying differential immunotherapy responses in fibrosis-associated lung cancer, a translational sub-study analyzes available archived lung tumor specimens (e.g., bronchoscopic biopsy, computed tomography-guided biopsy, or surgical samples). Single-cell transcriptomics and spatial transcriptomics are performed to compare tumors arising in a fibrotic lung environment with tumors from patients without ILD. These analyses identify fibrosis-associated cellular states, immune microenvironment composition, and signaling programs that may contribute to altered immunotherapy sensitivity or toxicity. Findings from the multi-omics analyses are integrated with clinical outcome data to generate mechanistic hypotheses and potential biomarkers relevant to immunotherapy decision-making in lung cancer patients with pulmonary fibrosis/ILD.
- Being tested
- there is no intervention
- Keywords
- Lung cancer, Pulmonary fibrosis, Immune checkpoint inhibitor, Tumor microenvironment, Single-cell RNA sequencing, Interstitial lung disease
- Medical subject headings
- Lung Neoplasms, Disease, Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer without pulmonary fibrosis | patients with lung cancer without lung fibrosis Receives: Other: there is no intervention | |
| Lung cancer with pulmonary fibrosis | Not described Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: up to 36 months
Secondary outcomes (2)
Progression-free survival (PFS)
Measured: up to 36 months
Objective response rate (ORR)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396467
- Sponsor's protocol ID
- IPF-LC-001
- Acronym
- IPF-LC-IO
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07396467
- Acronym / sponsor ID
- IPF-LC-IO / IPF-LC-001
- Keywords
- Lung cancer, Pulmonary fibrosis, Immune checkpoint inhibitor, Tumor microenvironment, Single-cell RNA sequencing, Interstitial lung disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer with concomitant pulmonary fibrosis/interstitial lung disease (ILD) represents a clinically challenging population in which immune checkpoint inhibitor (ICI) treatment may be influenced by baseline lung vulnerability and a distinct tumor immune microenvironment. This single-center retrospective observational cohort study evaluates how fibrosis/ILD status and related clinical features are associated with immunotherapy use, effectiveness, and safety.
Patients with pathologically confirmed lung cancer and radiographic evidence of pulmonary fibrosis/ILD diagnosed and treated at Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University) are identified. A comparator cohort of lung cancer patients without radiographic ILD from the same institution and time period is assembled to enable direct comparisons of immunotherapy outcomes. Baseline demographics, smoking history, comorbidities, pulmonary function and imaging features (when available), tumor histology and stage, relevant laboratory indices, and molecular testing results are collected and analyzed. Associations between these variables and ICI exposure or clinical outcomes are evaluated.
Primary analyses focus on immunotherapy-related endpoints, including real-world measures of ICI effectiveness such as objective response and survival outcomes captured in routine clinical care. Safety analyses include ILD-relevant outcomes such as immune-related pneumonitis, acute exacerbation of underlying ILD, treatment interruption or discontinuation, and other clinically significant pulmonary adverse events. Comparative analyses evaluate whether patients with lung cancer and fibrosis/ILD experience different ICI effectiveness or higher pulmonary toxicity risk compared with patients without ILD. Additional analyses explore which clinical, radiographic, pathological, or molecular features within the ILD cohort are associated with favorable or unfavorable immunotherapy outcomes.
To investigate potential mechanisms underlying differential immunotherapy responses in fibrosis-associated lung cancer, a translational sub-study analyzes available archived lung tumor specimens (e.g., bronchoscopic biopsy, computed tomography-guided biopsy, or surgical samples). Single-cell transcriptomics and spatial transcriptomics are performed to compare tumors arising in a fibrotic lung environment with tumors from patients without ILD. These analyses identify fibrosis-associated cellular states, immune microenvironment composition, and signaling programs that may contribute to altered immunotherapy sensitivity or toxicity. Findings from the multi-omics analyses are integrated with clinical outcome data to generate mechanistic hypotheses and potential biomarkers relevant to immunotherapy decision-making in lung cancer patients with pulmonary fibrosis/ILD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer without pulmonary fibrosis | – | Other: there is no interventionpatients with lung cancer without lung fibrosis |
| Lung cancer with pulmonary fibrosis | – | Other: there is no intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective, single-center observational cohort study of patients with pathologically confirmed lung cancer and imaging-confirmed interstitial lung disease (ILD) diagnosed at Jiangsu Provincial People's Hospital between January 2019 and September 2025. Eligible cases will be identified from hospital information systems and clinical records. Clinical characteristics, laboratory results, imaging, pathology and molecular reports will be extracted from Hospital Information System (HIS), Laboratory Information System (LIS), and Picture Archiving and Communication System (PACS) databases. Available tumor tissue specimens (bronchoscopic biopsy, CT-guided lung biopsy, or surgically resected lung tissue) will be collected for spatial transcriptomics analysis. Patients whose tumor location does not overlap with ILD-involved areas will be excluded.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- The anatomical location of the lung cancer lesion does not overlap with the ILD-involved area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no interventionthere is no intervention | Other | Lung cancer with pulmonary fibrosis, Lung cancer without pulmonary fibrosis |
Primary outcome
Overall survival (OS)
Time frame: up to 36 months
2 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 36 months
Objective response rate (ORR)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Pulmonary Fibrosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.