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

NCT ID: NCT05414630

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2025-06-30

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.

Conditions

Non-small Cell Lung Cancer Stage III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Envafolimab

Envafolimab: subcutaneous injection, 300mg, Q3W

Group Type: EXPERIMENTAL

Envafolimab

Intervention Type: DRUG

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

Interventions

Envafolimab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age at least 18 years.

2. Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.

3. The first dose of Envafolimab will be administered within 1-42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.

4. ECOG performance status 0-2.

5. Life expectancy ≥ 12 weeks.

6. Adequate organ function.

7. 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.

8. 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.

9. Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).

Exclusion Criteria

1. Disease progression after concurrent/sequential chemoradiotherapy.

2. Has received a live vaccine within 28 days prior to the first dose of investigational product.

3. Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.

4. Known positive driver gene mutation, such as EGFR sensitive mutation, ALK gene translocation or ROS1 rearrangement.

5. Received any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), with a washout period of less than 28 days.

6. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.

7. Subjects at active phase of chronic hepatitis B or with active hepatitis C.

8. History of organ transplantation.

9. History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).

10. Severe allergic reaction to other monoclonal antibodies.

11. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yue-Yin Pan

The Professor of Anhui Provincial Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Countries

China

Central Contacts

Yue-Yin Pan, PhD

Role: CONTACT

yueyinpan1965@126.com

0551-62282236

Facility Contacts

Yue-Yin Pan, PhD

Role: primary

yueyinpan1965@126.com

0551-62282236

Other Identifiers

SMA-NSCLC-009

Identifier Type: -

Identifier Source: org_study_id