A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer

NCT05414630 | Unknown Phase 2

• 1 other identifier: SMA-NSCLC-009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, phase II study to evaluate the efficacy and safety of Envafolimab in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Conditions

Non-small Cell Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival (PFS)

  Progression-free survival (PFS per RECIST 1.1) is defined as the time from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first.

  24 months after the last subject participating in.

Secondary Outcomes (4)

• Overall Survival (OS)

  24 months after the last subject participating in.

• Objective Response Rate (ORR)

  24 months after the last subject participating in.

• Duration of Response (DOR)

  24 months after the last subject participating in.

• Percentage of Patients Alive at 24 Months (OS24)

  24 months after the last subject participating in.

Study Arms (1)

Envafolimab

EXPERIMENTAL

Envafolimab: subcutaneous injection, 300mg, Q3W

Drug: Envafolimab

Interventions

Envafolimab DRUG

Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. The duration of treatment with Envafolimab should not exceed 2 years.

Envafolimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years.
• Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
• The first dose of Envafolimab will be administered within 1-42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
• ECOG performance status 0-2.
• Life expectancy ≥ 12 weeks.
• Adequate organ function.
• For female subjects of childbearing age, urine or serum pregnancy test shall be conducted before receiving the first study drug administration, and the result is negative.
• The subject and the subject's sexual partner need to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period.
• Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).

You may not qualify if:

• Disease progression after concurrent/sequential chemoradiotherapy.
• Has received a live vaccine within 28 days prior to the first dose of investigational product.
• Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
• Known positive driver gene mutation, such as EGFR sensitive mutation, ALK gene translocation or ROS1 rearrangement.
• Received any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), with a washout period of less than 28 days.
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
• Subjects at active phase of chronic hepatitis B or with active hepatitis C.
• History of organ transplantation.
• History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).
• Severe allergic reaction to other monoclonal antibodies.
• Subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, 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

Central Study Contacts

Yue-Yin Pan, PhD

CONTACT

0551-62282236; yueyinpan1965@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Professor of Anhui Provincial Cancer Hospital

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)