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:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT05027867
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT
* Disease must be measurable per RECIST Version 1.1
* Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
* Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
* ECOG ≤ 2
Exclusion Criteria:
* Symptomatic or uncontrolled central nervous system (CNS) metastases.
* Prior treatment with MDM2 inhibitors
* Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
* Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
* History of major organ transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05027867
Study Brief:
Protocol Section:
NCT05027867