A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Limertinib+bevacizumab
  • Limertinib

Treatment groups

136 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Shanghai Chest Hospital

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Collaborator