A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Vers… (NCT06982924) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.
136 participantsStarted 2025-06-30
Plain-language summary
A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent prior to any study - related procedures.
✓. Age ≥ 18 years.
✓. Histologically or cytologically confirmed non - squamous non - small cell lung cancer (NSCLC).
✓. Patients with locally advanced (IIIB - IIIC), metastatic, or recurrent (Stage IV) disease, as staged according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer (AJCC) 9th edition TNM staging for lung cancer, who are not candidates for surgical or radiation therapy.
✓. Confirmed EGFR - sensitive mutations (Ex19del, L858R) in tumor histology or cytology or in hematology.
✓. PD - L1 expression with a Combined Positive Score (CPS) ≥ 25%.
✓. ECOG performance status score of 0 - 1.
✓. No prior treatment with anti - angiogenic inhibitors or EGFR - TKIs.
Exclusion criteria
✕. Pathologically diagnosed with small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and NSCLC.
✕. Patients who have received any EGFR - TKI treatment or anti - angiogenic therapy.
✕. Received the following treatments: - Systemic anti - tumor treatment such as chemotherapy, targeted therapy, or immunotherapy (including traditional Chinese medicine for anti - tumor purposes) within 3 weeks prior to treatment. - Any investigational drug treatment within 4 weeks prior to treatment. - High - dose immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day prednisone or equivalent doses) within 4 weeks prior to treatment. - Attenuated live vaccines within 4 weeks prior to treatment (or planned to receive attenuated live vaccines during the study period). - Major surgery (such as open - cavity, open - chest, or laparotomy) within 4 weeks prior to treatment, or unresolved surgical wounds, ulcers, or fractures.
✕. Clinically uncontrollable pleural effusion/peritoneal effusion (subjects who do not require drainage of effusion or whose effusion does not significantly increase after stopping drainage for 3 days are eligible for inclusion).
✕. Subjects who received chest radiotherapy with a dose greater than 30Gy within 6 months prior to treatment, or palliative radiotherapy with a dose of 30Gy or less within 7 days prior to treatment (palliative radiotherapy for bone lesions or intracranial lesions is allowed).
✕. Active autoimmune diseases that required systemic treatment (such as disease - modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose of study drug. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
✕. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
✕. Known allergy to the active ingredients or excipients of the study drugs bevacizumab and lerotinib.