NCT Number: NCT07775820
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Checkpoint inhibitor pneumonitis is an important immune-related adverse event associated with immune checkpoint inhibitor treatment. Some patients with lung cancer may require immune checkpoint inhibitor rechallenge after recovery from pneumonitis because of tumor progression or limited subsequent treatment options. However, evidence regarding the safety and effectiveness of PD-L1 inhibitor rechallenge after checkpoint inhibitor pneumonitis remains limited.
This is a multicenter, ambispective, observational cohort study. The time perspective is classified as Other because the study combines retrospective review of existing medical records with prospective follow-up according to routine clinical visits.
Adults with histologically confirmed lung cancer who developed checkpoint inhibitor pneumonitis will be included. Participants will be classified into three cohorts according to routine clinical treatment decisions:
No participant will be randomly assigned to treatment, and the study protocol will not require any specific treatment, additional visit, laboratory test, or imaging examination. Treatment decisions will be made independently by the treating physicians.
Clinical information will be obtained from routine medical records and follow-up assessments. Data collected will include demographic characteristics, lung cancer characteristics, previous cancer treatment, initial checkpoint inhibitor treatment, characteristics and management of checkpoint inhibitor pneumonitis, subsequent antitumor treatment, immune-related adverse events, tumor response, disease progression, and survival.
The primary objective is to compare the recurrence of checkpoint inhibitor pneumonitis after PD-L1 inhibitor and PD-1 inhibitor rechallenge. Secondary objectives include comparisons of progression-free survival, overall survival, recurrence or new onset of other immune-related adverse events, objective response rate, and disease control rate. Exploratory analyses will evaluate clinical factors associated with the safety and effectiveness of PD-L1 inhibitor rechallenge.
A non-probability sampling approach will be used to include eligible cases available at the participating centers. The planned enrollment is 150 participants, with approximately 50 participants in each cohort.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Participants do not restart PD-1 or PD-L1 inhibitor therapy after checkpoint inhibitor pneumonitis. Subsequent antitumor management follows routine clinical practice.
Time frame: 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.
Time frame: From the date of immune checkpoint inhibitor rechallenge to the first documented recurrence of another immune-related adverse event, death, or study completion, whichever occurs first, assessed for up to 5 years.
The percentage of participants in the PD-L1 inhibitor and PD-1 inhibitor rechallenge cohorts who experience recurrence of a previous other immune-related adverse event or development of a new other immune-related adverse event after rechallenge, as documented in the medical records.
Time frame: From the date of initiation of the initial immunotherapy until tumor progression, death, or study completion, whichever occurs first, assessed for up to 8 years.
From the prespecified index date until tumor progression, death, or study completion, whichever occurs first
Time frame: From the date of initiation of the initial immunotherapy until death, or study completion, whichever occurs first, assessed for up to 8 years.
From the prespecified index date until death or study completion, whichever occurs first
Time frame: Up to 24 weeks after initiation of the post-pneumonitis treatment strategy
The percentage of participants who achieve a best overall response of complete response or partial response within 24 weeks after initiation of the post-pneumonitis treatment strategy, based on routine clinical tumor response assessments documented in the medical records.
Time frame: Up to 24 weeks after initiation of the post-pneumonitis treatment strategy
The percentage of participants who achieve a best overall response of complete response, partial response, or stable disease within 24 weeks after initiation of the post-pneumonitis treatment strategy, based on routine clinical tumor response assessments documented in the medical records.
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
Efficacy and Safety of PD-L1 Inhibitor Rechallenge After Immune Checkpoint Inhibitor-Related Pneumonitis in Patients With Lung Cancer: A Multicenter Real-World Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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