A Clinical Study of Immunotherapy Combined With Chemotherapy and Anti-angiogenic Therapy in Operable NSCLC

NCT05360979 | Unknown Phase 2

• 1 other identifier: NSCLC-LXL002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective, single-arm, single-center clinical study is to evaluate the efficacy and safety of envafolimab combined with platinum-containing dual-drug chemotherapy and recombinant human endostatin regimens for treating patients with operable II, IIIA, and IIIB (T3N2) stage NSCLC.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• MPR rate

  Major pathological reaction (MPR), defined as remaining viable tumor cells ≤ 10% at surgical resection of the primary tumor.MPR rate, defined as the proportion of intention-to-treat (ITT) population reaching MPR.

  0-36months

Secondary Outcomes (5)

• the event-free survival (EFS)

  0-36months

• the complete pathological remission rate (pCR)

  0-36months

• the disease-free survival (DFS)

  0-36months

• the 3-year survival rate and overall survival (OS)

  0-36months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, AEs, TEAEs, SAEs,irAEs

  0-36months

Study Arms (1)

Neoadjuvant and adjuvant therapy

EXPERIMENTAL

After signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy.

Drug: envafolimab

Interventions

envafolimab DRUG

Envafolimab: 300 mg, D1, Q3W, subcutaneously administered

Also known as: recombinant human endostatin, chemotherapy

Neoadjuvant and adjuvant therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects fully understand the research and voluntarily sign the informed consent form (ICF);
• Subjects are aged between 18 to 70 years, irrespective of gender;
• Patients with resectable stage II, stage IIIA, and stage IIIB (T3N2) (AJCC staging 8th edition) NSCLC with no prior treatment and confirmed by histology; TNM staging can be confirmed by positron emission tomography (PET)-computed tomography (CT) or pathological biopsy;
• The presence of measurable lesions according to version 1.1 of the evaluation standard for the efficacy of solid tumors;
• Tumor tissue specimens can be submitted for pathological diagnosis, programmed death-ligand 1 (PD-L1) expression, and biomarker detection before enrollment (tumor tissues must be fresh specimens or archived samples obtained within three months before enrollment; tumor tissue specimen must be histological samples, including, but not limited to, puncture tissues obtained by thick and hollow needles, tissues obtained by bronchoscope clamps, or surgical removal samples. Puncture tissues obtained by fine needles and samples obtained by bronchial brushing are unacceptable);
• Eastern Cooperative Oncology Group (ECOG) score 0-1;
• Good organ function;
• Hematology: Absolute neutrophil count (ANC) ≥ 1500/μL; platelets ≥ 100000/μL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L;
• Kidney: Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance rate (CrCl) ≥ 60 mL/min (using Cock-Gault formula);
• Liver: total bilirubin ≤ 1.5 × ULN or for subjects with total bilirubin level \> 1.5 × ULN, direct bilirubin within normal limits; Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 2.5 × ULN;
• Patients are willing and able to comply with the research plan's visits, treatment plans, laboratory examinations, and other research procedures;
• According to the assessment of the surgeon, the total lung function can withstand the planned lung resection;
• Women of childbearing age must undergo a serum pregnancy test within 3 days before the first treatment, and the result should be negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to use high-efficiency methods of contraception during the study and within 180 days after the last administration of the study drug.

You may not qualify if:

• \- 1. Presence of unresectable or metastatic disease; 2. Subjects with NSCLC, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumors involving the upper sulcus; subjects with non-squamous NSCLC with known EGFR (epidermal growth factor receptor) mutations or ALK translocations; 3. Subjects with early-stage NSCLC who previously received systemic anticancer treatment, including experimental drug treatment; subjects with a history of (non-infectious) pneumonia/interstitial lung disease that requires steroid treatment, or currently present pneumonia/interstitial disease that requires steroid treatment pulmonary disease; 4. Subjects with a history of active tuberculosis; 5. Subjects with active infections requiring systemic treatment; 6. Subjects with known or suspected autoimmune diseases or immunodeficiency, except for patients with a history of hypothyroidism who do not need hormone therapy or are receiving physiological dose hormone replacement therapy; subjects with stable type I diabetes with controlled blood sugar levels; 7. Subjects with uncontrolled active hepatitis B (defined as a positive test result for hepatitis B virus surface antigen \[HBsAg\] during the screening period, and the detection value of HBV-DNA exceeds the ULN value of the laboratory department of the research center); (Subjects whose HBV-DNA content \<500 IU/mL tested within 28 days before enrollment, and have received at least 14 days of local standard antiviral therapy and are willing to continue to receive antiviral therapy during the study period can be included); Subjects with active hepatitis C (defined as a positive test result of hepatitis C virus surface antibody \[HCsAb\] and HCV-RNA positive during the screening period); 8. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 9. Subjects vaccinated with a live vaccine within 30 days before the first administration, including, but not limited to, the following: mumps, rubella, measles, chickenpox/shingles (chickenpox), yellow fever, rabies, Bacille Calmette-Guerin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); 10. Subjects who previously received PD-1/PD-L1 drug treatment or treatment of another drug targeting T cell receptors (such as CTLA-4 and OX-40); 11. Subjects who have had a severe allergic reaction to other monoclonal antibodies; 12. Subjects who have a history of severe allergies to pemetrexed, paclitaxel or albumin paclitaxel or docetaxel, cisplatin, carboplatin, recombinant human endostatin active ingredients, or preventive medications; 13. Subjects who are known to have serious or uncontrolled underlying diseases; 14. Subjects presenting malignant tumors other than NSCLC within 5 years before the first administration. Malignant tumors with negligible risk of metastasis or death (e.g., expected DFS\> 5 years) and expected curative results after treatment (e.g., fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, radical surgery treated ductal carcinoma in situ) can be excluded.
• \. Subjects with grade III-IV congestive heart failure (New York Heart Association classification) and poorly controlled and clinically significant arrhythmia; 16. Subjects who have experienced any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before selection for treatment.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

the second Xiangya hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

envafolimab; Endostatins; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the oncology department of the Second Xiangya Hospital of Central South University

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: May 4, 2022
• Study Start: May 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2025
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)