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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.