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
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Progress Free Survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
Envafolimab
Envafolimab: subcutaneous injection, 300mg, Q3W
Intervention: Envafolimab (Drug)
Outcomes
Primary Outcomes
Progress Free Survival (PFS)
Time Frame: 24 months after the last subject participating in.
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 Outcomes
- Duration of Response (DOR)(24 months after the last subject participating in.)
- Objective Response Rate (ORR)(24 months after the last subject participating in.)
- Overall Survival (OS)(24 months after the last subject participating in.)
- Percentage of Patients Alive at 24 Months (OS24)(24 months after the last subject participating in.)
Investigators
Yue-Yin Pan
The Professor of Anhui Provincial Cancer Hospital
Anhui Provincial Cancer Hospital