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PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer

NCT07775820 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-08-20

No results posted yet for this study

Summary

This multicenter observational study will evaluate the safety and effectiveness of immune checkpoint inhibitor rechallenge in adults with lung cancer who developed checkpoint inhibitor pneumonitis.

The study will use both retrospective medical records and prospective follow-up data. Participants will not be assigned to any treatment by the study protocol. All treatment decisions will be made by the treating physicians as part of routine clinical care.

Participants will be classified into three groups according to their subsequent treatment: rechallenge with a PD-L1 inhibitor, rechallenge with a PD-1 inhibitor, or no immune checkpoint inhibitor rechallenge. The primary outcome is the recurrence of checkpoint inhibitor pneumonitis after rechallenge. Secondary outcomes include immune-related adverse events, progression-free survival, overall survival, objective response rate, and disease control rate at 24 weeks.

Approximately 150 participants will be included across multiple study centers in China.

Conditions

  • Lung Cancer
  • Rechallenge
  • Checkpoint Inhibitor Pneumonitis

Interventions

DRUG

PD-L1 Inhibitor Rechallenge

Restarting immune checkpoint inhibitor treatment with a PD-L1 inhibitor after checkpoint inhibitor pneumonitis has improved and immunotherapy has been interrupted because of pneumonitis. The treatment is selected by the treating physician and is not assigned by the study protocol.

DRUG

PD-1 Inhibitor Rechallenge

Restarting immune checkpoint inhibitor treatment with a PD-1 inhibitor after checkpoint inhibitor pneumonitis has improved and immunotherapy has been interrupted because of pneumonitis. The treatment is selected by the treating physician and is not assigned by the study protocol.

DRUG

No Immune Checkpoint Inhibitor Rechallenge

Participants do not restart PD-1 or PD-L1 inhibitor therapy after checkpoint inhibitor pneumonitis. Subsequent antitumor management follows routine clinical practice.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775820 on ClinicalTrials.gov