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NCT07204548PHASE2NOT_YET_RECRUITING

The IVO-LUNG Study

Ivonescimab Consolidation After Concurrent/Sequential Chemoradiation for Unresectable Stage III NSCLC- A Phase II Study

Sponsor: Sun Yat-sen University

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Key Facts

Study type
INTERVENTIONAL
Conditions
Non Small Cell Lung Cancer (Stage III)
Interventions
Ivonescimab
Enrollment
63 participants
Primary completion
Oct 2027
Study completion
Oct 2029
First posted
Oct 2025
Last updated
Oct 2025

Primary Endpoints (CT.gov)

12-month PFS rate

Time frame: From the date of enrollment untill 12 month

Secondary Endpoints

Objective Response Rate(ORR)

Progression free survival

overall survival

Eligibility Criteria

Inclusion Criteria: 1. Provide voluntary written informed consent. 2. age: 18-75 years old 3. ECOG performance status: 0 or 1 4. With a life expectancy of ≥ 3 months. 5. Patients with radiologically confirmed, treatment-naïve, unresectable Stage III NSCLC (staged according to the American Joint Committee on Cancer, 8th edition) who did not progress after definitive concurrent/sequential chemoradiotherapy. Induction therapy prior to chemoradiotherapy was permitted. 6. Negative for EGFR L858R/19del, ALK fusion, ROS1 fusion, RET fusion, BRAF V600E mutation, NTRK fusion, and MET exon 14 skipping mutation. 7. Presence of at least one measurable lesion per RECIST v1.1, which is suitable for accurate and reproducible repeated measurements. 8. For the exploration of efficacy-related biomarkers, the submission of tumor tissue, peripheral blood, and stool samples is required. Patients with biologically unavailable samples may be granted an exemption from this requirement. 9. Adequate organ func

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✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov