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.
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.
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).
Parallel
Limertinib+bevacizumab
DrugThe advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive the combination of Limertinib with bevacizuma in first-line treatment
Limertinib
DrugThe advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive Limertinib in first-line treatment
PFS
the investigator assessed PFS
ORR
the investigator assessed objective response rate
OS
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Shanghai Chest Hospital
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
