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

Primary Purpose

Non-small Cell Lung Cancer Stage III

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Envafolimab

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Anhui Provincial Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Envafolimab

Arm Description

Envafolimab: subcutaneous injection, 300mg, Q3W

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Objective Response Rate (ORR)

The proportion of subjects with complete response (CR) and partial response (PR) in total subjects.

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.

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.

Full Information

NCT ID

NCT05414630

First Posted

June 8, 2022

Last Updated

June 8, 2022

Sponsor

Anhui Provincial Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05414630

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Anhui Provincial Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer Stage III

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Envafolimab

Arm Type

Experimental

Arm Description

Envafolimab: subcutaneous injection, 300mg, Q3W

Intervention Type

Drug

Intervention Name(s)

Envafolimab

Intervention Description

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

Primary Outcome Measure Information:

Title

Progress Free Survival (PFS)

Description

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.

Time Frame

24 months after the last subject participating in.

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time Frame

24 months after the last subject participating in.

Title

Objective Response Rate (ORR)

Description

The proportion of subjects with complete response (CR) and partial response (PR) in total subjects.

Time Frame

24 months after the last subject participating in.

Title

Duration of Response (DOR)

Description

Time Frame

24 months after the last subject participating in.

Title

Percentage of Patients Alive at 24 Months (OS24)

Description

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.

Time Frame

24 months after the last subject participating in.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yue-Yin Pan, PhD

Phone

0551-62282236

yueyinpan1965@126.com

Facility Information:

Facility Name

Anhui Provincial Cancer Hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230031

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yue-Yin Pan, PhD

Phone

0551-62282236

yueyinpan1965@126.com

12. IPD Sharing Statement

Plan to Share IPD

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

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