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

Study Overview
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Brief Summary
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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.

Detailed Description
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Trial design: This is a single-arm, open-label trial in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after concurrent/sequential chemoradiotherapy to evaluate the efficacy of Envafolimab as a consolidation treatment of the efficacy and safety. Background:The PACIFIC and GEMSTONE-301 studies have shown the efficacy of immunization as consolidation therapy in stage III NSCLC. Patients with stage III NSCLC who did not have disease progression after at least two cycles of concurrent/sequential chemoradiotherapy (including platinum) will receive Envafolimab (300mg, Q3W, subcutaneous injection) within 1-42 days after the end of chemoradiotherapy. The maximum duration of Envafolimab treatment is 2 years.

Official Title
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A Prospective, Single-arm Clinical Study of Envafolimab as Consolidation Therapy in Patients With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Concurrent/Sequential Chemoradiotherapy

Conditions
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Non-small Cell Lung Cancer Stage III

Intervention / Treatment
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* Drug: Envafolimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Envafolimab<br>Envafolimab: subcutaneous injection, 300mg, Q3W | Drug: Envafolimab<br>* Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. The duration of treatment with Envafolimab should not exceed 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. | 24 months after the last subject participating in. | 
| Objective Response Rate (ORR) | The proportion of subjects with complete response (CR) and partial response (PR) in total subjects. | 24 months after the last subject participating in. | 
| Duration of Response (DOR) | DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. | 24 months after the last subject participating in. | 
| Percentage of Patients Alive at 24 Months (OS24) | OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months. | 24 months after the last subject participating in. |