Neoadjuvant of Sintilimab Combined With Chemotherapy for Resectable NSCLC（neoSCORE）

NCT04459611 | Unknown Phase 2

• 1 other identifier: 2020-KYY-518052-0092
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, prospective, randomized, open-Label, single-center international study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for resectable NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Conditions

Non-small Cell Lung Cancer

Keywords

sintilimab; resectable NSCLC; neoadjuvant immunochemotherapy

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate (MPR)

  MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.

  At time of surgery

Secondary Outcomes (4)

• Pathology complete response rate(pCR)

  At time of surgery

• Objective response rate (ORR)

  prior to surgery

• 2 years disease-free survival rate (DFS)

  2 years postoperatively

• 2 years overall survival rate (OS)

  2 years postoperatively

Study Arms (2)

sintilimab+chemotherapy(2 cycles of neoadjuvant chemotherapy)

EXPERIMENTAL

Patients with nonsquamous NSCLC (including adenocarcinoma, large cell carcinoma and unspecified type) : sintilimab + pemetrexed + carboplatin; Patients with squamous NSCLC : sintilimab + albumin-bound paclitaxel + carboplatin; Followed by surgery within the 4th week after the second dose of sintilimab; Followed by 2 cycles of adjuvant chemotherapy, the researcher will decide whether to radiotherapy or not according to the clinical situation and pathological stage of the patient; Followed by the maintenance treatment of sintilimab for up to 1 year according to the requirements of patients.

Biological: sintilimab; Drug: pemetrexed; Drug: Carboplatin; Drug: albumin-bound paclitaxel

sintilimab+chemotherapy(3 cycles of neoadjuvant chemotherapy)

EXPERIMENTAL

Patients with nonsquamous NSCLC (including adenocarcinoma, large cell carcinoma and unspecified type) : sintilimab + pemetrexed + carboplatin; Patients with squamous NSCLC : sintilimab + albumin-bound paclitaxel + carboplatin; Followed by surgery within the 4th week after the third dose of sintilimab; Followed by 1 cycles of adjuvant chemotherapy, the researcher will decide whether to radiotherapy or not according to the clinical situation and pathological stage of the patient; Followed by the maintenance treatment of sintilimab for up to 1 year according to the requirements of patients.

Biological: sintilimab; Drug: pemetrexed; Drug: Carboplatin; Drug: albumin-bound paclitaxel

Interventions

sintilimab BIOLOGICAL

200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

Also known as: IBI308, PD-1 antibody

sintilimab+chemotherapy(2 cycles of neoadjuvant chemotherapy); sintilimab+chemotherapy(3 cycles of neoadjuvant chemotherapy)

pemetrexed DRUG

500 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

sintilimab+chemotherapy(2 cycles of neoadjuvant chemotherapy); sintilimab+chemotherapy(3 cycles of neoadjuvant chemotherapy)

Carboplatin DRUG

AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 1.

sintilimab+chemotherapy(2 cycles of neoadjuvant chemotherapy); sintilimab+chemotherapy(3 cycles of neoadjuvant chemotherapy)

albumin-bound paclitaxel DRUG

260 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

sintilimab+chemotherapy(2 cycles of neoadjuvant chemotherapy); sintilimab+chemotherapy(3 cycles of neoadjuvant 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 the informed consent form before starting any trial related procedure.
• years old, male or female.
• Non-small cell lung cancer confirmed by cytology or histology.
• There must be at least one evaluable focus judged according to recist1.1 standard.
• Evaluation by the researchers to confirm resectable stage cⅠb-Ⅲa NSCLC patients without any treatment before.
• ECOG PS 0-1.
• Life expectancy \> 6 months.
• Adequate organ function and it should meet the following criteria:
• No use of Granulocyte colony stimulating factor within 14 days, absolute neutrophils count(ANC)≥1.5x109/L, platelets count(PLT)\>9g/dL, hemoglobin(HB)≥100×109/L;
• Total bilirubin(TBIL)≤1.5ULN, ALT、AST≤ 2.5 ULN, serum creatinine(sCr)≤1.5ULN;
• good blood coagulation: INR≤1.5 or PT≤1.5 ULN;
• normal thyroid function: TSH within normal institutional limits;
• Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose(cycle 1 day 1) with negative results. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required.

You may not qualify if:

• Malignancies within 5 years prior to the first dose(excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and / or radical resection of carcinoma in situ).
• Currently participating in the intervention clinical treatment, or receiving other drugs or research instruments within 4 weeks before the first dose.
• Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or drugs for another stimulation or synergistic inhibition of T cell receptor (e.g. CTLA-4, OX-40, CD137).
• Active autoimmune diseases requiring systemic treatment (e.g. using disease improving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first dose. Alternative therapies (e.g. thyroxine, insulin or corticosteroids in physiological doses for adrenal or pituitary insufficiency) are not considered systemic treatment.
• Systemic glucocorticoid therapy (excluding local glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy is in progress within 7 days before the first dose.
• Note: it is allowed to use physiological dose of glucocorticoid (Prednisone≤10 mg/d or equivalent drug).
• Received allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Allergic to study drug(sintilimab, pemetrexed, carboplatin, albumin-bound paclitaxel) components excipients.
• Not fully recovered from toxicity and/or complications caused by any intervention before treatment (≤level 1 or reach baseline, excluding fatigue or hair loss).
• Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
• Untreated active Hepatitis B (defined as HBsAg positive and HBV-DNA copies\>ULN).
• Active Hepatitis C (HCV antibody positive and HCV-RNA level higher than the detection limit).
• Inoculate the live vaccine within 30 days before the first dose (cycle 1 day 1).
• Note: it is allowed to receive the injection inactivated virus vaccine for seasonal influenza within 30 days before the first dose; however, it is not allowed to accept the live attenuated influenza vaccine for intranasal medication.
• Pregnant or lactating women.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Shao M, Yao J, Wang Y, Zhao L, Li B, Li L, Wu Z, Chen Z, Fan J, Qiu F. Two vs three cycles of neoadjuvant sintilimab plus chemotherapy for resectable non-small-cell lung cancer: neoSCORE trial. Signal Transduct Target Ther. 2023 Apr 10;8(1):146. doi: 10.1038/s41392-023-01355-1. No abstract available.

  PMID: 37032401 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; spartalizumab; Pemetrexed; Carboplatin; Albumin-Bound Paclitaxel

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)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: July 1, 2023
• Last Updated: July 12, 2022

Record last verified: 2021-09

Locations

CN (1)