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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

ConditionsPatients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLCEGFR Mutation-negative and ALK Rearrangement-negativeEastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2No Prior Systemic Therapy Received for the Advanced or Metastatic DiseasePD-L1 Positive, as Determined by a Validated Assay
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in the study and provision of written informed consent approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Age ≥ 18 years at enrollment, male or female.

Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) according to the International Association for the Study of Lung Cancer (IASLC) 9th edition TNM classification, and judged by the investigator as not amenable to curative surgery or definitive concurrent chemoradiotherapy.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.

Disqualifiers

Histological diagnosis containing small cell carcinoma or neuroendocrine carcinoma components.

Currently participating in another interventional clinical study.

Known actionable driver alterations in *EGFR*, *ALK*, *ROS1*, *RET*, or other driver genes for which first-line approved therapies are available.

History of severe bleeding tendency or coagulation disorders; clinically significant bleeding symptoms within 1 month before the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expelling ≥ 1 teaspoon of fresh blood or small blood clots, or expectorating only blood without sputum; subjects with blood-streaked sputum are eligible), or nasal bleeding (excluding epistaxis and blood-tinged postnasal drip).

Trial population

This study population consists of adult patients with locally advanced or metastatic, driver gene-negative, PD-L1-positive non-small cell lung cancer (NSCLC) who initiate ivonescimab monotherapy as first-line systemic treatment in routine clinical practice. Eligible patients will be consecutively identified and enrolled from multiple participating centers in China. Clinical, pathological, and imaging data will be collected from medical records and follow-up visits to describe real-world effectiveness and safety outcomes associated with ivonescimab treatment in this setting.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ivonescimab Injection

    Drug

    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 enrolled in the study will receive first-line Ivonescimab monotherapy until disease progression or unacceptable toxicity occurs. The recommended dosage of Ivonescimab is 20 mg/kg administered via intravenous infusion every 3 weeks. Each infusion should be completed over 60 minutes (± 10 minutes). For patients intolerant to 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 adverse event management will follow the instructions in the drug label and relevant guidelines. Any concomitant supportive treatments or medications administered during the s

Treatment groups

265 Participants
are divided into 1 treatment group
Group A: First-line Ivonescimab Monotherapy in PD-L1-Positive NSCLC1 intervention

Trial outcomes

Primary outcomes

1

median rwPFS

Real-world median progression-free survival (median rwPFS) assessed by the investigator per RECIST v1.1 is defined as the time from the first dose of Ivonescimab to the first documented disease progression (PD) as determined by the treating physician in the medical records, or death from any cause, whichever occurs first.

Time frame
From date of first dose to date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 36 months.

Secondary outcomes

1

Real-world Duration of Response (rwDoR)

Real-world duration of response (rwDoR) is defined as the time from the date of first documented complete response (CR) or partial response (PR) to the date of first documented disease progression or death from any cause, whichever occurs first, as recorded in routine clinical practice. Tumor response will be assessed by the treating physician based on radiologic evaluations and clinical judgment, generally guided by RECIST v1.1 where available.

Time frame
From date of first documented CR/PR to date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
2

Overall Survival (OS)

Overall survival (OS) is defined as the time from the date of first Ivonescimab administration to death from any cause. Patients who are alive at the time of analysis or lost to follow-up will be censored at the date they were last known to be alive according to medical records or follow-up contacts.

Time frame
From date of first dose to date of death from any cause, assessed up to 60 months.
3

Real-world Time to Response (rwTTR)

Real-world time to response (rwTTR) is defined as the time from the date of first Ivonescimab administration to the date of first documented CR or PR in routine clinical practice. Tumor response will be evaluated by the treating physician based on radiologic assessments and clinical judgment, generally guided by RECIST v1.1 where available.

Time frame
From date of first dose to date of first documented CR/PR, assessed up to 36 months.
4

Real-world Objective Response Rate (rwORR)

Real-world objective response rate (rwORR) is defined as the proportion of patients who achieve a best overall response of CR or PR during Ivonescimab treatment in routine clinical practice. The denominator will include all patients in the effectiveness analysis set. Responses will be determined by the treating physician based on radiologic assessments and clinical judgment, generally guided by RECIST v1.1 where available.

Time frame
Baseline and post-baseline tumor assessments during follow-up, assessed up to 36 months.

Other outcomes

Sponsors and contacts

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Guangdong Association of Clinical Trials

Lead sponsor

Source ClinicalTrials.gov
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