A Study to Prospectively Validate Blood Markers Associated With Differences in Efficacy of Neoadjuvant Therapy for NSCLC

NCT06503042 | Not Yet Recruiting

• 1 other identifier: K202407-07
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study utilized a prospective cohort design. It is proposed to analyze the serum of NSCLC patients treated with chemotherapy combined with immunotherapy, and chemotherapy alone, starting from liquid biopsy technique and combining with proteomic methods. By comparing the differences in serum proteins between the two groups of patients before treatment, we will validate the targets related to efficacy and AE events identified in a previous retrospective study, further explore their associations with patients' clinical outcomes and AE events, and establish a clinical prediction model to guide and improve the current treatment of NSCLC.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• pCR rate

  rate of pathological complete response

  4 months

• MPR rate

  rate of major pathologic response

  4 months

Secondary Outcomes (1)

• AE

  4 months

Study Arms (2)

Chemotherapy combined with immunotherapy group

NSCLC patients undergoing neoadjuvant chemotherapy combined with immunotherapy regimens

Drug: Chemotherapy combined with immunotherapy

Chemotherapy group

NSCLC patients undergoing neoadjuvant chemotherapy regimens

Drug: Chemotherapy only

Interventions

Chemotherapy combined with immunotherapy DRUG

Patients in the chemotherapy combined with immunotherapy group use any chemotherapy drug in combination with any immunotherapy drug. The premise is that the treatment regimen for patients is consistent with the diagnostic and treatment protocols.

Chemotherapy combined with immunotherapy group

Chemotherapy only DRUG

Patients in the chemotherapy alone group use any chemotherapy drug. The premise is that the treatment regimen for patients is consistent with the diagnostic and treatment protocols.

Chemotherapy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer undergoing neoadjuvant chemotherapy combined with immunotherapy or neoadjuvant chemotherapy at the Thoracic Surgery Department of Tang Du Hospital.

You may qualify if:

• Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol
• Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)
• Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC
• Have adequate organ and bone marrow function, and the laboratory examination values within 14 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin and other intravenous or subcutaneously administered drugs to correct hematological or liver and kidney dysfunction were allowed within the first 14 days of obtaining laboratory tests), as follows:
• ①Hematological function was sufficient, defined as absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 100g / L;
• ②Full liver function, defined as total bilirubin level ≤ 1.5 × ULN, AST and ALT level ≤ 2.5 × ULN, albumin (ALB) ≥ 35g / L;
• Renal function was sufficient, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL / min (calculated by Cockcroft / Gault formula) and urine routine test results showed that urinary protein (UPRO) \< 2 + or 24-hour urinary protein \< 1g;
• The international normalized ratio (INR) ≤ 1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN within 7 days before treatment;
• For women of childbearing age, urine or serum pregnancy tests were negative for at least seven days prior to the first study drug administration. If the urine pregnancy test is positive, a blood pregnancy test is required;
• If there is a risk of conception, male and female patients need to use high-efficiency contraception (i.e., the method with an annual failure rate of less than 1 %) and continue until at least 180 days after discontinuation of the trial; Note: If abstinence is the normal lifestyle and preferred contraceptive method of the subjects, abstinence can be accepted as a contraceptive method.

You may not qualify if:

• Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components
• Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body
• pulmonary sulcus tumor
• Contralateral lung nodules, it need biopsy if clinically suspected
• Subjects with confirmed or suspected brain metastases
• Participation in an interventional clinical study or treatment with another investigational drug or investigational device within 4 weeks prior to enrollment
• Previous use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy
• Received immunomodulatory drugs (including thymidine, interferon, interleukins, etc.) within the first 4 weeks of enrollment
• Live attenuated vaccine within the first 4 weeks of enrollment (or plan to receive live attenuated vaccine during the study period). Note: Inactivated seasonal influenza vaccine is permitted, but live attenuated influenza vaccine is not permitted
• Requires prolonged systemic glucocorticoid use and has received any other form of immunosuppressive therapy within 7 days prior to enrollment Note: Nasal spray, inhalation, or other topical glucocorticoid or physiologic doses of systemic glucocorticoid (≤ 10 mg/day of prednisone or equivalent) are permitted or are used for pretreatment (e.g., for prevention of contrast allergy).
• History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to enrollment or current interstitial lung disease (≥ grade 2)
• Active autoimmune disease including, but not limited to, inflammatory bowel disease such as ulcerative colitis or Crohn's disease requiring systemic therapy (e.g., use of disease modifying medications, corticosteroids, or immunosuppressive drugs) within the 2 years prior to enrollment Diverticulitis, celiac disease, systemic lupus erythematosus, sarcoidosis-like or Wegener's syndrome (granulomatous polyangiitis), Graves' disease, rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis, antiphospholipid syndrome, pituitary gland inflammation, and uveitis. Replacement therapies (e.g., thyroxine, insulin, or physiologic doses of corticosteroids for adrenal or pituitary dysfunction) are not considered systemic therapy. Patients with positive autoimmune antibodies will be enrolled only after evaluation by the investigator to confirm that there are no autoimmune diseases requiring systemic therapy.
• Primary immunodeficiency diseases
• Pre-existing or current myocarditis
• incomplete recovery from toxicity and/or complications resulting from any intervention prior to enrollment (\> grade 1 or not recovered to baseline levels)

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy

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)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Tao Jiang

CONTACT

8613572592311; jiangtao@fmmu.edu.cn

Yiming Ma

CONTACT

8618630668336; 1366343502@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share