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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05055167
Other study ID # SMA-NSCLC-006
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 30, 2021
Est. completion date June 30, 2025

Study information

Verified date September 2021
Source The First Affiliated Hospital of Xiamen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date June 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Envafolimab
single agent, 300mg Q3W IH until disease progressed

Locations

Country Name City State
China First affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Almonertinib to the end of study. 48 months
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