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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anhui Provincial Cancer Hospital

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.