A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC

NCT06485557 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT20240507
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles. Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.

Conditions

Resectable Non-small Cell Lung Cancer

Keywords

NSCLC; Neoadjuvant; Sintillumab

Outcome Measures

Primary Outcomes (1)

• pCR rate

  rate of pathological complete response

  4 months

Secondary Outcomes (3)

• MPR rate

  4 months

• R0 resectability rate

  4 months

• The completion rate of surgery on schedule

  4 months

Study Arms (3)

group A

EXPERIMENTAL

receive 3 cycles of sintilimab plus platinum-based chemotherapy

Drug: sintilimab plus platinum-based chemotherapy

group B

EXPERIMENTAL

receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab

Drug: sintilimab plus platinum-based chemotherapy

group C

EXPERIMENTAL

receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab

Drug: sintilimab plus platinum-based chemotherapy

Interventions

sintilimab plus platinum-based chemotherapy DRUG

The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy

Also known as: Group A

group A

Eligibility Criteria

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

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
• Age ≥ 18 years
• Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)
• Subjects with Stage IIA (primary focus\>4cm), IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8), resectable N2 only refers to non-massive (defined as short diameter less than 3cm), discrete or single station N2 involvement.
• No EGFR sensitive mutations and ALK rearrangements should be tested in non-squamous non-small cell lung cancer, and will be not mandatory in squamous cell carcinoma
• Deemed radically resectable with curative intent
• Pulmonary function reached the standard of planned pneumonectomy ( FEV1 ≥ 50 % predicted value, MVV ≥ 50 % predicted value ), and there was no surgical contraindication
• Enough tissue samples for PD-L1 detection (Number of slices ≥ 6)
• At least one measurable lesion in line with RECIST V1.1
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• 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:
• Hematological function was sufficient, defined as absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 100g / L;
• Full 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;

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
• Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization
• 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 drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within the first 4 weeks of randomization
• Received live attenuated vaccine within the first 4 weeks of randomization（Or plan to receive live attenuated vaccine during the study period） Note: Acceptance of inactivated vaccine for seasonal influenza is permitted; however, live attenuated influenza vaccine is not allowed
• Need long-term systemic use of corticosteroids，received any other form of immunosuppressive therapy within 7 days before randomization Note: Nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (≤ 10mg / day prednisone or equal doses of drugs) or for pretreatment (such as prevention of contrast agent allergy) use is allowed
• A history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease (≥ grade 2) within the previous year of randomization
• Active autoimmune diseases, including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn \'s disease, that require systemic treatment ( such as the use of disease-modifying drugs, corticosteroids or immunosuppressants ), have occurred within the first two years of the randomization; diverticulitis; chylous diarrhea; systemic lupus erythematosus; sarcoidosis syndrome or wegener syndrome ( granuloma with polyangiitis); graves\' disease; rheumatoid arthritis; multiple sclerosis; vasculitis; glomerular nephritis; antiphospholipid syndrome; pituitary inflammation; uveitis, etc. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary dysfunction) are not considered as systemic treatments. Patients with positive autoimmune antibodies need to be evaluated by researchers to confirm that there is no autoimmune disease that requires systemic treatment before they can be enrolled
• Primary immunodeficiency disease
• Previous or current myocarditis
• Not fully recovered from toxicity and/or complications caused by any intervention before randomization (\> grade 1 or not recovery to baseline)

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Interventions

sintilimab; Platinum Compounds

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Central Study Contacts

Xiaolong Yan

CONTACT

8615991269383; yanxiaolong@fmmu.edu.cn

mingliang xing

CONTACT

15129745755; 312596733@QQ.COM

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective Cohort Study

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share