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The IVO-LUNG Study

ConditionNon Small Cell Lung Cancer (Stage III)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This Phase II, open-label, single-arm study evaluates the efficacy and safety of one-year Ivonescimab consolidation therapy in patients with unresectable Stage III NSCLC who have not progressed after definitive chemoradiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide voluntary written informed consent.

age: 18-75 years old

ECOG performance status: 0 or 1

With a life expectancy of ≥ 3 months.

Disqualifiers

Patients with non-small cell lung cancer (NSCLC) that contains a small cell carcinoma component.

History of other malignancies (except carcinoma in situ of the cervix, non-melanoma skin cancer, bladder carcinoma in situ, etc.) or presence of other life-threatening diseases that may affect the completion of the study.

Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study.

Imaging during the screening period shows tumor invasion or the presence of significant necrosis or cavitation, and the investigator judges that study entry would pose a bleeding risk.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivonescimab

    Drug

    Ivonescimab is given after definitive concurrent/sequential chemoradiotherapy

Treatment groups

63 Participants
are divided into 1 treatment group
Group A: Ivonescimab as consolidation after definitive concurrent/sequential chemoradiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

12-month PFS rate

The percentage of patients who has not experienced first documented progression or date of death from any cause, whichever came first, assessed up to 12 months from the date of enrollment.

Time frame
From the date of enrollment untill 12 month

Secondary outcomes

1

Objective Response Rate(ORR)

(Number of patients with CR + Number of patients with PR) / Total number of evaluable patients based on the RECIST V1.1

Time frame
From the date of enrollment untill the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months"
2

Progression free survival

From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Time frame
From the date of enrollment to the date of first documented progression or date of death from any cause, assessed up to 100 months.
3

overall survival

Survival time from enrollment to death

Time frame
From enrollment to death
4

Treatment related adverse event

Any unfavorable and unintended sign, symptom, or disease that occurs in a participant during a clinical trial, which is deemed to have a reasonable possibility of being caused by the study treatment.

Time frame
From enrollment to discontinuation of the study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: