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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT05098132
Eligibility Criteria:
Selected Inclusion Criteria:
1. Phase 1 \[closed to enrollment\]
2. Phase 2 \[open to enrollment\]:
* Diagnosis of non-small cell lung cancer (NSCLC).
* Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
* Non-squamous (NSQ) cell histology.
* No prior systemic therapy for advanced/metastatic NSQ NSCLC.
* Tumor is PD-L1 negative (TPS \<1%) by local testing.
* No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.
Selected Exclusion Criteria:
1. Phase 1 \[closed to enrollment\]
2. Phase 2 \[open to enrollment\]:
* Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
* Tumor with small cell, neuroendocrine, or sarcomatoid components.
* Received radiotherapy ≤ 7 days of the first dose of study treatment.
* Known untreated central nervous system metastases
* Any history of carcinomatous meningitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05098132
Study Brief:
Protocol Section:
NCT05098132