Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT05705466
Eligibility Criteria:
Inclusion Criteria:
* ECOG 0-1
* Histologically or cytologically confirmed diagnosis of NSCLC documented as TP53WT
* Locally advanced or metastatic disease; must have completed up to 4 cycles of platinum-based chemo plus CPI and achieved a CR or PR per RECIST V1.1
* Adequate hematologic, hepatic and renal function (within 14 days)
Exclusion Criteria:
* Symptomatic or uncontrolled central nervous system (CNS) metastases
* Prior treatment with a MDM2 inhibitor
* Grade 2 or higher QTc prolongation (\>480 msec per NCI-CTCAE criteria version 5.0)
* History of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks
* History of major organ transplant
* Active pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis
* Prior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 days
* Medical condition, serious intercurrent illness, psychiatric condition or other circumstance that, in the Investigator's judgment could jeopardize the subject's safety, or that could interfere with study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05705466
Study Brief:
Protocol Section:
NCT05705466