Trial Title:
Local Injection and Systemic Therapy in the Treatment of NSCLC.
NCT ID:
NCT06618391
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Endostatins
Conditions: Keywords:
Envafolimab
Recombinant human endostatin
Recombinant Human Adenovirus Type 5
Intratumor local injection
NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Envafolimab
Description:
Envolimab :150 mg/time, intratumoral injection, at least 5 sites; Recombinant human
endostatin： Q3W for 4-6 cycles，Maintenance therapy 210 mg ,CIV 72 hours ,administered as
continuous intravenous pump, administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2,
D1, Q3W,for 4-6 cycles，intravenous drip.
Arm group label:
Envafolimab
Other name:
PD-L1
Intervention type:
Drug
Intervention name:
Recombinant human endostatin
Description:
Recombinant human endostatin: 15mg/time, intratumoral injection, at least 5 sites;
Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection;
administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6
cycles，intravenous drip.
Arm group label:
Recombinant human endostatin
Other name:
Endostar
Intervention type:
Drug
Intervention name:
recombinant human adenovirus type 5
Description:
Recombinant Human Adenovirus Type 5: 1.0ml/time, intratumoral injection, at least 5
sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous
injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6
cycles，intravenous drip.
Arm group label:
Recombinant human adenovirus type 5
Other name:
OncorineR
Summary:
This study is a prospective, exploratory Phase II clinical study aimed at evaluating the
safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human
Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients
with locally advanced or advanced non-small cell lung cancer(NSCLC).
Detailed description:
This study is a prospective, exploratory Phase II clinical study aimed at evaluating the
safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human
Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients
with locally advanced or advanced non-small cell lung cancer(NSCLC).
Patients with pathologically confirmed unresectable locally advanced/advanced NSCLC with
atelectasis were screened and eligible subjects were randomized to receive local
intratumoral injection of envolumab/Endostar/recombinant human adenovirus type 5 H101
combined with systemic therapy after signing informed consent.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to participate and sign the informed consent form；
2. ≥ 18 years old; Both men and women are eligible；
3. Histologically or cytologically confirmed advanced or metastatic locally advanced,
advanced (Stage IIIB, IIIC, or IV) NSCLC without mutations in driver gene testing;
4. Patients with recurrent or metastatic NSCLC who have previously failed first-line
standard therapy;
5. According to Response Evaluation Criteria in Solid Tumors (RECIST1.1), there should
be at least one measurable lesion as a target lesion, and the measurable lesion
should not have received local therapy such as radiotherapy;
6. Atelectasis Radiographically assessed atelectasis with at least one lobe;
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
8. Expected survival ≥3 months;
9. Major organ functions within 7 days prior to treatment meeting the following
criteria:(1) Blood routine examination criteria (without blood transfusion within 14
days) : ① Hemoglobin (HB) ≥90g/L; ② absolute neutrophil count (ANC) ≥1.5×10^9/L; ③
Platelet (PLT) ≥80×10^9/L. (2) Biochemical examination should meet the following
criteria: ① Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); ②
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN, if
accompanied by liver metastasis, ALT and AST≤5×ULN; ③ Serum creatinine (Cr) ≤1.5×ULN
or creatinine clearance (CCr)≥60ml/min; ④ Serum albumin ≥35g/L. (3) Doppler
ultrasound assessment: Left ventricular ejection fraction (LVEF)≥lower limit of
normal (50%).
10. For female subjects of childbearing potential, a negative urine or serum pregnancy
test should be obtained 3 days prior to receiving the first dose of study drug;
11. Subject and subject sexual partner need to use contraceptive measures (eg
intrauterine device, contraceptive pill , or condom) during the study treatment
period and for 6 months after the end of the study treatment period;
Exclusion Criteria:
1. Severe metamorphosis/allergic reaction to humanized antibodies or fusion proteins;
2. Known hypersensitivity to Endostar or any component of the antibody formulation;
3. Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any
other form of immunosuppressive therapy within 14 days prior to the first dose of
study, physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent)
are permitted;
4. Exclude subjects with active, known, or suspected autoimmune diseases (such as
interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis,
hypothyroidism, including but not limited to these diseases or syndromes). Subjects
who have type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin
conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or
hair loss), or conditions that are not expected to recur in the absence of external
triggers may be enrolled;
5. Patients with severe heart disease, including congestive heart failure, uncontrolled
high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart
valve disease;
6. Patients who have previously received targeted therapy with vascular endothelial
growth inhibitors, such as bevacizumab, Sunitinib, sorafenib, imatinib, Famitinib,
Regafenib, Apatinib, androtinib, etc.
7. Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction
inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to receiving trial
drug) planned within 4 weeks prior to group assignment or during this study.
Expansion field radiotherapy (EF-RT) within 4 weeks before grouping or limited field
radiotherapy to assess tumor lesions within 2 weeks before grouping;
8. Active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (hepatitis C
antibody positive and HCV-RNA higher than the lower limit of assay);
9. Active pulmonary tuberculosis (TB) infection was judged based on chest X-ray, sputum
examination, and clinical examination. Patients with a history of active pulmonary
tuberculosis infection within the previous year, even if treated, were excluded;
patients with a history of active pulmonary tuberculosis infection more than 1 year
ago, unless the course and type of anti-tuberculosis treatment previously used were
proven to be appropriate.
10. Patients with brain metastases accompanied by symptoms or symptom control time less
than 2 months;
11. Received significant surgical treatment, open biopsy, or obvious traumatic injury
within 28 days prior to grouping;
12. imaging showed that the tumor has invaded important blood vessels or the
investigator judged that the tumor is likely to invade important blood vessels
during the subsequent study period and cause fatal bleeding;
13. regardless of severity, patients with any signs of bleeding constitution or medical
history; within 4 weeks before grouping, patients with any bleeding or bleeding
events ≥ CTCAE grade 3, with unhealed wounds, ulcers or fractures;
14. Hyperarterial/venous thrombotic events within 6 months, such as cerebrovascular
accident (including transient ischemic attack), deep venous thrombosis and pulmonary
embolism;
15. According to the investigator 's judgment, there are concomitant diseases that
seriously endanger the safety of patients or affect the completion of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 8, 2024
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618391
