Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC(neoSCORE Ⅱ):A Prospective, Randomized, Open-Label, Multi-Center Phase 3 Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

• 18-75 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).

Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Fuming Qiu
qiufuming@zju.edu.cn
13858005908
Time Frame
Start Date: 2022-11-11
Estimated Completion Date: 2029-11-11
Participants
Target number of participants: 250
Treatments
Experimental: Arm A(3 cycles of neoadjuvant therapy)
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.
Experimental: Arm B(4 cycles of neoadjuvant therapy)
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.
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov