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

A Phase II Study of Envafolimab as First-line Treatment of Aged Patients With High PD-L1 Expression Stage in Advanced Non-small-cell Lung Cancer(NSCLC)

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 .

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer Stage IV
• Intervention / Treatment: Drug: Envafolimab

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • First Affiliated Hospital of Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Envafolimab; Elderly NSCLC Patients with high PD-L1 expression	Drug: Envafolimab; single agent, 300mg Q3W IH until disease progressed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SMA-NSCLC-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No