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NCT07594522PHASE1, PHASE2RECRUITING

A Study of Ivonescimab in People With Non-Small Cell Lung Cancer

Phase II Study of Ivonescimab Consolidation After Photon or Proton SBRT for Patients With Early-Stage NSCLC (I-PRECISE)

Sponsor: Memorial Sloan Kettering Cancer Center

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Key Facts

Study type
INTERVENTIONAL
Conditions
Non-Small Cell Lung Cancer
Interventions
Photon or Proton standard stereotactic body radiotherapy (SBRT), Ivonescimab
Enrollment
36 participants
Primary completion
May 2028
Study completion
May 2028
First posted
May 2026
Last updated
May 2026

Primary Endpoints (CT.gov)

24-month event-free survival

Time frame: 24 months

Secondary Endpoints

24-month overall survival

Eligibility Criteria

Criteria: * Patients must have pathologically confirmed non-small cell lung cancer * Early Stage NSCLC Stage IA2 - IIA (tumor size \> 1cm and ≤ 5cm, N0M0), select IIB (tumor size \>5cm and ≤ 7cm, N0M0). Multiple (up to 2) primary lung cancers allowed. Isolated parenchymal recurrences (tumor size ≤ 7cm and up to 2 separate ipsilateral lesions) of initially TanyN0M0 disease. ° Note: The determination of two primary NSCLCs will be based on pathologic and genomic differentiation. * No known sensitizing EGFR or ALK alterations * Disease amenable to 3, 5 or 8 fraction SBRT as judged by treating radiation oncologist. Tumors that have extensive overlap with the mediastinum for which a more protracted radiotherapy course (i.e. 15 fraction) would be needed are excluded. * No primary tumor (Gross Target Volume, GTV) that contacts the esophagus * Unwilling to undergo surgical resection or ineligible for surgical resection as determined by review of a multidisciplinary team for surgical candida

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov