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

NCT05055167 | Unknown Phase 2 DMC

• 1 other identifier: SMA-NSCLC-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Non-small Cell Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Envafolimab

EXPERIMENTAL

Elderly NSCLC Patients with high PD-L1 expression

Drug: Envafolimab

Interventions

Envafolimab DRUG

single agent, 300mg Q3W IH until disease progressed

Envafolimab

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

First affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

envafolimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: August 30, 2021
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)