Clinical Study of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Non-small Cell Lung Cancer

NCT05170581 | Unknown Phase 2

• 1 other identifier: MT-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

By exploring the feasibility, effectiveness and safety of neoadjuvant therapy with Sintilimab combined with platinum-containing chemotherapy in patients with resectable Stage ⅡB-ⅢA NSCLC, we will provide new treatment options and strategies for stage ⅡB-ⅢA NSCLC.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Sintilimab; Neoadjuvant Treatment

Outcome Measures

Primary Outcomes (2)

• Major pathological remission

  Residual tumor cells were less than 10% in postoperative specimen pathology

  3 years

• Event-free survival

  The time from enrollment to occurrence of any event, including death, disease progression, change of chemotherapy regimen, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects.

  3 years

Secondary Outcomes (4)

• Pathological complete remission

  3 years

• Overall Survival

  3 years

• Disease-free survival

  3 years

• Objective remission rate

  3 years

Study Arms (1)

PD-1 inhibitor combined with chemotherapy

EXPERIMENTAL

Sintilimab will be administered one day before platinum-containing chemotherapy.

Drug: Sintilimab Combined with Platinum-containing Chemotherapy

Interventions

Sintilimab Combined with Platinum-containing Chemotherapy DRUG

Admininster Sintilimab and platinum-containing chemotherapy in neoadjuvant treatment of resectable stage ⅡB～ⅢA Non-small Cell Lung Cancer

Also known as: PD-1 inhibitor combined with chemotherapy

PD-1 inhibitor combined with chemotherapy

Eligibility Criteria

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

You may qualify if:

• \. Sign written informed consent prior to implementing any trial-related procedures; 2. Male or female ≥18 years old and ≤75 years old; 3. Cytological or histological diagnosis of non-small cell lung cancer; 4. According to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one lesion can be measured on imaging; 5. Untreated stage ⅰ B - ⅲ A non-small cell lung cancer (TNM staging according to UICC/AJCC Edition 8); 6. Primary tumor can be biopsied; 7. Patients who agree to receive radical surgical treatment; 8. Patients who can be resected by surgeons and have no contraindications; 9. ECOG score 0-1; 10. Expected survival time \> 6 months; 11. Adequate organ function, subject will meet the following laboratory criteria: 1) Absolute value of neutrophils (ANC) ≥1.5x10\^9/L without the use of granulocyte colony-stimulating factor in the last 14 days. 2) Platelets ≥100×10\^9/L in the last 14 days without blood transfusion. 3) In the absence of blood transfusion or erythropoietin in the last 14 days, hemoglobin\>9 g/dL. 4) Total bilirubin ≤1.5× upper normal value (ULN); 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×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 standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled; 9) The myocardial enzyme profile is within the normal range (if the investigator comprehensively determines that the simple laboratory abnormality is not clinically significant, it is allowed to be included in the group); 12. For female subjects of reproductive age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy; If there is a risk of pregnancy, all subjects (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% for the entire treatment period up to 120 days after the last study drug (or 180 days after the last chemotherapeutic drug).

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, 271000, China

RECRUITING

Related Publications (2)

• Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.

  PMID: 32979984 BACKGROUND

• Gao S, Li N, Gao S, Xue Q, Ying J, Wang S, Tao X, Zhao J, Mao Y, Wang B, Shao K, Lei W, Wang D, Lv F, Zhao L, Zhang F, Zhao Z, Su K, Tan F, Gao Y, Sun N, Wu D, Yu Y, Ling Y, Wang Z, Duan C, Tang W, Zhang L, He S, Wu N, Wang J, He J. Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC. J Thorac Oncol. 2020 May;15(5):816-826. doi: 10.1016/j.jtho.2020.01.017. Epub 2020 Feb 6.

  PMID: 32036071 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

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)

Therapeutics

Study Officials

• Haiyan Liu

  The Second Affiliated Hospital of Shandong First Medical Universuty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Miao

CONTACT

+86-13854893531; miaoyue0626@126.com

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: December 24, 2021
• First Posted: December 28, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

CN (1)