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NCT07009925PHASE2NOT_YET_RECRUITING

Phase II Study of Platinum (Cisplatin/Carboplatin)and Polymeric Micelles Paclitaxel(Pm-Pac) With Ivonescimab in First Line Metastatic Squamous NSCLC.

Ivonescimab Combined With Polymeric Micelles Paclitaxel(Pm-Pac) and Platinum (Cisplatin/Carboplatin) as First-line Treatment for Patients With Advanced Squamous NSCLC: A Multicenter, Open-label, Single-arm Clinical Study.

Sponsor: Jiangsu Cancer Institute & Hospital

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Squamous Cell Lung Cancer
Interventions
Ivonescimab 20mg/kg intravenous every 3 weeks
Enrollment
38 participants
Primary completion
May 2027
Study completion
May 2028
First posted
Jun 2025
Last updated
Jun 2025

Primary Endpoints (CT.gov)

progression-free survival

Time frame: From the start of treatment until disease progression or death (assessed up to 24 months)

Secondary Endpoints

Objective Response Rate

Disease Control Rate

Duration of Response

Eligibility Criteria

Inclusion Criteria: 1. Written informed consent must be signed before implementing any trial-related procedures; 2. Age ≥18 years old; 3. Patients with histologically or cytologically confirmed metastatic or recurrent (stage IV) squamous NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging), inoperable or inappropriate for radical concurrent chemoradiotherapy, and without previous systemic treatment;. Patients with mixed histology (example adenosquamous) are allowed if there is squamous component in the specimen. PD-L1 immunohistochemical results is required before enrollment. 5.According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one measurable lesion. 6.Have not received any previous systemic antitumor therapy for advanced/metastatic diseases. Participants who have previously received platinum-based adjuvant/neoadjuvant chemotherapy, or radic

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