OncoMatch/Clinical Trials/NCT07696832
Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study
Is NCT07696832 recruiting? Yes, currently enrolling (Jul 2026). Studying Ivonescimab for patients must have histologically or cytologically confirmed locally advanced or metastatic nsclc.
Treatment: Ivonescimab — The treatment decisions, assessment schedule, and study procedures in this research will adhere to the routine clinical practice of each participating center. The specifics are as follows: Treatment Decisions: Treatment will be administered in accordance with the officially approved drug label for Ivonescimab by the National Medical Products Administration (NMPA) and the latest domestic and international guidelines. Eligible patients meeting the inclusion criteria will receive first-line Ivonescimab monotherapy until disease progression or unacceptable toxicity occurs. The recommended dosage of Ivonescimab is 20 mg/kg administered intravenously every 3 weeks. Each infusion should be completed over 60 minutes (± 10 minutes). For patients who cannot tolerate the 60-minute (± 10 minutes) infusion, the duration may be extended to a maximum of 120 minutes (± 10 minutes). Dosing may be interrupted or permanently discontinued based on individual patient safety and tolerability; however, dose increases or reductions are not recommended. Dose modification and management of adverse events will follow the drug label and relevant guidelines. Any other concomitant supportive care or medications during the study period should be based on a comprehensive patient assessment, excluding contraindications explicitly stated in the label or guidelines, and administered according to the routine clinical practice of each center. Assessment Plan: The timing, items, and frequency of all assessments, including tumor imaging evaluations and laboratory tests, will follow the routine clinical practice of each participating center. Study Procedures: This study does not mandate protocol-defined study visits. A suggested visit schedule is provided solely to facilitate unified data collection and management. Investigators will prospectively and continuously collect clinical data for all patients who provide signed informed consent and meet the eligibility criteria via an Electronic Data Capture (EDC) system until a study endpoint event occurs or the study concludes.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (TPS ≥ 1%)
Tumor tissue PD-L1 expression positive, defined as tumor proportion score (TPS) ≥ 1% (any antibody clone), as determined by a central laboratory or a qualified pathology department accredited by the study site
Required: EGFR wild-type
EGFR Mutation-negative
Required: ALK wild-type
ALK Rearrangement-negative
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anticancer therapy for locally advanced or metastatic NSCLC
Exception: neoadjuvant/adjuvant therapy with curative intent allowed if time from last treatment to recurrence/metastasis > 6 months
No prior systemic anticancer therapy for locally advanced or metastatic NSCLC. Subjects who have received neoadjuvant/adjuvant therapy with curative intent are eligible if the time from last treatment to recurrence/metastasis is > 6 months.
Cannot have received: systemic immunotherapy targeting tumor immune evasion mechanisms
Prior treatment with systemic immunotherapy targeting tumor immune evasion mechanisms, including immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4, TIGIT, or LAG3 inhibitors) or immune checkpoint agonists (e.g., CD40, CD137, ICOS, OX40, GITR antibodies), or cellular immunotherapy
Cannot have received: systemic anti-angiogenic therapy (bevacizumab, ramucirumab, endostatin, apatinib, anlotinib)
Prior treatment with systemic anti-angiogenic therapy (including but not limited to bevacizumab and its biosimilars, ramucirumab, endostatin, apatinib, anlotinib, etc.)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07696832 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy for locally advanced or metastatic NSCLC, systemic immunotherapy targeting tumor immune evasion mechanisms, systemic anti-angiogenic therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify