Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）

NCT05429463 | Recruiting Phase 3 DMC

• 1 other identifier: neoSCORE Ⅱ
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Conditions

Squamous Cell Non-small Cell Lung Cancer

Keywords

Sintilimab; Squamous Cell 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 (5)

• 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

• 2 years event free survival (EFS)

  2 years after randomization

Study Arms (2)

Arm A(3 cycles of neoadjuvant therapy)

EXPERIMENTAL

Neoadjuvant: Prior to surgery, participants receive up to 3 cycles (cycle length: 3 weeks) of sintilimab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with neoadjuvant chemotherapy, consisting of albumin-bound paclitaxel \[260 mg/m\^2, IV; given on cycle day 1\] and carboplatin \[AUC 5- 6mg/mL/min, IV; given on cycle day 1 \] . Adjuvant: Followed by surgery within the 3-5th week after the last dose of sintilimab, the researcher will decide whether to radiotherapy or not according to the clinical situation and pathological stage of the patient. The maintenance treatment of sintilimab \[200 mg, intravenous (IV); given on cycle day 1; cycle length: 3 weeks\] may be selected upon subject request for up to 1 year.

Biological: Sintilimab; Drug: Carboplatin; Drug: Albumin-Bound Paclitaxel

Arm B(4 cycles of neoadjuvant therapy)

EXPERIMENTAL

Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of sintilimab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with neoadjuvant chemotherapy, consisting of albumin-bound paclitaxel \[260 mg/m\^2, IV; given on cycle day 1\] and carboplatin \[AUC 5- 6mg/mL/min, IV; given on cycle day 1 \] . Adjuvant: Followed by surgery within the 3-5th week after the last dose of sintilimab, the researcher will decide whether to radiotherapy or not according to the clinical situation and pathological stage of the patient. The maintenance treatment of sintilimab \[200 mg, intravenous (IV); given on cycle day 1; cycle length: 3 weeks\] may be selected upon subject request for up to 1 year.

Biological: Sintilimab; 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

Arm A(3 cycles of neoadjuvant therapy); Arm B(4 cycles of neoadjuvant therapy)

Carboplatin DRUG

AUC 5-6 mg/mL/min by IV infusion Q3W, given on cycle day 1.

Arm A(3 cycles of neoadjuvant therapy); Arm B(4 cycles of neoadjuvant therapy)

Albumin-Bound Paclitaxel DRUG

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

Arm A(3 cycles of neoadjuvant therapy); Arm B(4 cycles of neoadjuvant therapy)

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.Be willingness and able to undergo planned visits, protocol therapy, laboratory tests and other testing procedures.
• years old, male or female.
• Squamous Cell 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 and classified by the 8th version of AJCC TNM staging to confirm resectable stage cⅡA-ⅢB squamous NSCLC patients without any treatment before.
• ECOG PS 0-1.
• Life expectancy \> 6 months.
• Adequate organ function and it should meet the following criteria:
• Absolute value of neutrophils (ANC) ≥1.5×109/L in the absence of granulocyte colony stimulating factor for the past 14 days; Platelet ≥100×109/L in the last 14 days without blood transfusion; Hemoglobin \>9g/dL in the absence of blood transfusion or erythropoietin in the last 14 days ;
• 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;
• For women of reproductive age, a urine or serum pregnancy test with negative results 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 nonreproductive age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy. If there is a risk of conception, all subjects (both men and women) will use a medically approved highly effective contraceptive (e.g., an intrauterine device, birth control pill, or condom) for the entire treatment period up to 120 days after the last study drug (or 180 days after the last chemotherapy drug).

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, 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

RECRUITING

Related Publications (1)

• Zhang X, Shao M, Yao J, Zhao L, Li L, Chen M, Zhang Y, Liu H, Chen Z, Li B, Wu Z, Fan J, Qiu F. NeoSCORE II: three vs four cycles of neoadjuvant sintilimab + chemotherapy for squamous non-small-cell lung cancer. Future Oncol. 2024 Jan;20(3):121-129. doi: 10.2217/fon-2024-0026. Epub 2024 Feb 14.

  PMID: 38353107 DERIVED

MeSH Terms

Interventions

sintilimab; spartalizumab; Carboplatin; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Fuming Qiu

CONTACT

13858005908; qiufuming@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 23, 2022
• Study Start: November 11, 2022
• Primary Completion: November 11, 2025
• Study Completion (Estimated): November 11, 2029
• Last Updated: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)