First-line Replacement Maintenance of Envafolimab in Advanced NSCLC

NCT05465733 | Unknown Phase 2

• 1 other identifier: No.XJTU1AF2022LSK-263
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, prospective, single-arm phase II clinical study. For newly-treated patients with advanced NSCLC with negative driver gene and positive PD-L1 expression, those patients who did not progress after 4-6 cycles of PD-1 or PD-1 combined with chemotherapy standard treatment, after signing the informed consent form, were screened to meet the criteria for inclusion and exclusion. Standard, will receive Envafolimab combined with chemotherapy/Envafolimab single-agent first-line maintenance therapy until disease progression, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other protocol-specified conditions that should be discontinued Circumstances, whichever occurs first.

Conditions

Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• progression free survival

  time from the randomization to the first disease progression or death

  3-year

Study Arms (1)

Envafolimab

EXPERIMENTAL

Drug: Envafolimab;Pemetrexed

Interventions

Envafolimab;Pemetrexed DRUG

single agent, 300mg Q3W IH until disease progressed,The duration of treatment with Envafolimab should not exceed 2 years.

Envafolimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
• Age 18-75 years old;
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
• Patients with non-small cell lung cancer (NSCLC) who have received PD-1 or PD-1 combined with chemotherapy and have not progressed in previous first-line therapy;
• According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), at least one lesion that can be measured by imaging. Lesions located in the field of previous radiotherapy can be regarded as measurable lesions if they are confirmed to have progressed;
• An archived tumor tissue sample or newly obtained (no anti-tumor therapy since biopsy) core or tumor foci (no prior radiotherapy) excisional biopsy has been provided. Formalin-fixed and paraffin-embedded (FFPE) tissue blocks are preferred over sections. The newly obtained biopsy tissue is superior to the archived tissue, and the tissue sample is detected by immunohistochemistry for PD-L1 ≥ 1%;
• ECOG score 0-1 points;
• Expected survival time ≥ 3 months;
• Sufficient organ function, subjects should meet the following laboratory indicators:
• (1) The absolute value of neutrophils (ANC) is ≥1.5x109/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets ≥100×109/L without platelet transfusion or thrombopoietin use in the past 14 days; (3) Hemoglobin\>9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin \> ULN but direct bilirubin ≤ ULN (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN); (6) Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; for patients receiving anticoagulation therapy, PT/INR is within the required treatment criteria; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to be included in the group); 10. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 11.If there is a risk of conception, all subjects (whether male or female) are required to use an annual failure rate of less than 1 throughout the treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug) % of contraception.

You may not qualify if:

• Patients with known EGFR sensitive mutations or ALK rearrangements;
• Patients who have received first-line standard treatment and progressed in the past;
• Subjects with active central nervous system (CNS) metastasis, if the subject's CNS metastasis can be adequately treated, and the subject's neurological symptoms can return to baseline levels at least 2 weeks before enrollment treatment-related residual signs or symptoms), can participate in the study. In addition, the subject must also be a corticosteroid-free subject or receive a stable or tapering dose of ≤10 mg/day of prednisone (or equivalent);
• Received systemic systemic treatment of Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration;
• Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose;
• Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
• Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent) are allowed;
• Those who are known to be allergic to the active ingredients or excipients of the study drugs such as envolimab and pemetrexed;
• Pregnant or lactating women;
• Has not sufficiently recovered from toxicity and/or complications from any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment;
• Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center);
• Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• HBV viral load \<1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study treatment period to avoid viral reactivation;
• For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored; 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 14. Received live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injected inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not permitted.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Central Study Contacts

Yu Yao, PhD

CONTACT

029-85324600; yaoyu123@xjtufh.edu.cn

Xiao Fu

CONTACT

029-85324600

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 20, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)