Envafolimab as First-line Treatment of Aged Patients in Advanced NSCLC

• Status: Active, not recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Explore the efficacy and safety of Envafolimab in first line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression, view to providing better treatment options for elderly patients with high PD-L1 expression and improving the survival and prognosis of patients .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Criteria

Inclusion Criteria:

• Signed written informed consent.

• Age strictly at least 70 years.

• Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of locally advanced (stage IIIb/IIIc), metastatic, or relapsing (stage IV) according to the American Joint Committee on Cancer Staging Handbook.

• Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region.

• No previous systemic chemotherapy for lung cancer.

• PD-L1≥50% in tissue samples detected by immunohistochemistry.

• PS 0 or 1.

• Life expectancy sup 12 weeks.

• Normal hematologic function.

Exclusion Criteria:

• EGFR-sensitive mutations or ALK rearrangements

• Previous treatment with immune checkpoint inhibitors

• Presence of symptomatic brain metastases；

• Chinese patent medicine with anti-lung cancer indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for the local use of pleural effusion control) for systemic treatment；

• Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ；

• Concurrent administration of one or several other antitumor therapies；

• Concurrent participation in another clinical trial；

• Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial；

• Systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initial administration；

• Contraindication to the study drugs；

• Has not fully recovered from toxicity and/or complications caused by any intervention prior to the commencement of treatment (i.e., grade 1 or baseline, excluding fatigue or hair loss);

• A history of human immunodeficiency virus (HIV) infection;

• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);

• Active HCV infected;

• Recent vaccination within 30 days before the first administration (cycle 1, day 1);

• Other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).