Clinical Outcomes and Immunotherapy in Lung Cancer With Pulmonary Fibrosis

NCT07396467 | Active Not Recruiting

• 1 other identifier: IPF-LC-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer (Diagnosis); Pulmonary Fibrosis; Interstitial Lung Diseases

Keywords

Lung cancer; Pulmonary fibrosis; Immune checkpoint inhibitor; Tumor microenvironment; Single-cell RNA sequencing; Interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  up to 36 months

Secondary Outcomes (2)

• Progression-free survival (PFS)

  up to 36 months

• Objective response rate (ORR)

  up to 36 months

Other Outcomes (1)

• Adverse events (AEs)

  up to 36 months

Study Arms (2)

Lung cancer without pulmonary fibrosis

patients with lung cancer without lung fibrosis

Other: there is no intervention

Lung cancer with pulmonary fibrosis

Other: there is no intervention

Interventions

there is no intervention OTHER

there is no intervention

Lung cancer with pulmonary fibrosis; Lung cancer without pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• The anatomical location of the lung cancer lesion does not overlap with the ILD-involved area.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease; Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)