Status:
UNKNOWN
A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Anhui Provincial Cancer Hospital
Conditions:
Non-small Cell Lung Cancer Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05414630
Start Date
June 1 2022
End Date
June 1 2025
Last Update
June 10 2022
Active Locations (1)
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1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031