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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Recurrence Rate of Checkpoint Inhibitor Pneumonitis After Immune Checkpoint Inhibitor Rechallenge — From the date of immune checkpoint inhibitor rechallenge to the first documented CIP recurrence, death, or study completion, whichever occurs first, assessed for up to 5 years.
  The percentage of participants in the PD-L1 inhibitor rechallenge cohort and the PD-1 inhibitor rechallenge cohort who experience recurrent checkpoint inhibitor pneumonitis after restarting immune checkpoint inhibitor treatment. Recurrence will be determined according to the diagnosis documented by the treating physicians in the medical records.

Trial sites (5)

More Nanfang Hospital, Southern Medical University trials in China

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