Clinical trial · Observational
PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer
Efficacy and Safety of PD-L1 Inhibitor Rechallenge After Immune Checkpoint Inhibitor-Related Pneumonitis in Patients With Lung Cancer: A Multicenter Real-World Study
- 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 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
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 |
|---|---|---|---|
| Checkpoint Inhibitor Pneumonitis | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Rechallenge | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Immune Checkpoint Inhibitor Rechallenge | Drug | — | UNRESOLVED |
| PD-1 Inhibitor Rechallenge | Drug | — | UNRESOLVED |
| PD-L1 Inhibitor Rechallenge | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- PD-L1 Inhibitor Rechallenge Cohort
- description
- Participants with lung cancer who developed checkpoint inhibitor pneumonitis and subsequently restarted immune checkpoint inhibitor therapy with a PD-L1 inhibitor after interruption of immunotherapy because of pneumonitis. Rechallenge treatment is selected by the treating physician as part of routine clinical care and is not assigned by the study protocol.
- interventionNames
- Drug: PD-L1 Inhibitor Rechallenge
- label
- PD-1 Inhibitor Rechallenge Cohort
- description
- Participants with lung cancer who developed checkpoint inhibitor pneumonitis and subsequently restarted immune checkpoint inhibitor therapy with a PD-1 inhibitor after interruption of immunotherapy because of pneumonitis. Rechallenge treatment is selected by the treating physician as part of routine clinical care and is not assigned by the study protocol.
- interventionNames
- Drug: PD-1 Inhibitor Rechallenge
- label
- No Immune Checkpoint Inhibitor Rechallenge Cohort
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 2. Histologically confirmed lung cancer. 3. Development of checkpoint inhibitor pneumonitis after treatment with immune checkpoint inhibitor. 4. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 5. Provision of written informed consent. Exclusion Criteria: 1. Incomplete clinical information required for the study analyses. 2. Considered unsuitable for participation by the investigator.
References
Publications (0)
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