CClinicalTrials.gg
RecruitingNCT05429463neoSCORE ⅡUpdated Dec 14, 2022

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

A Phase 3 interventional study of Sintilimab and Carboplatin in Squamous Cell Non-small Cell Lung Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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. In this trial, eligible subjects will be randomly assigned to arm A and arm B (1:1). Subjects in arm A will receive 3 cycles of neoadjuvant sintilimab with chemotherapy and arm B will receive 4 cycles of neoadjuvant sintilimab with chemotherapy, followed by surgery within the 3-5th week after the last dose of sintilimab. After operation, both subjects in arm A and B can receive the treatment of sintilimab for up to 1 year according to the requirements of patients. The primary purpose is MPR rate of Resectable Squamous Cell NSCLC with different cycles of sintilimab combined with chemotherapy, which is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.

02

Conditions studied

  • Squamous Cell Non-small Cell Lung Cancer

Keywords

  • Sintilimab
  • Squamous Cell NSCLC
  • Neoadjuvant immunochemotherapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 250 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. 18-75 years old, male or female.
  3. Squamous Cell Non-small cell lung cancer confirmed by cytology or histology.
  4. There must be at least one evaluable focus judged according to recist1.1 standard.
  5. 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.
  6. ECOG PS 0-1.
  7. Life expectancy > 6 months.
  8. 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;

  9. 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).

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Currently participating in the intervention clinical treatment, or receiving other drugs or research instruments within 4 weeks before the first dose.
  3. 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).
  4. 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.
  5. 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).

  6. Received allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
  7. Allergic to study drug(sintilimab, carboplatin, albumin-bound paclitaxel) components excipients.
  8. Not fully recovered from toxicity and/ or complications caused by any intervention before treatment (≤level 1 or reach baseline, excluding fatigue or hair loss).
  9. Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
  10. Untreated active Hepatitis B (defined as HBsAg positive and HBV-DNA copies>ULN).
  11. Active Hepatitis C (HCV antibody positive and HCV-RNA level higher than the detection limit).
  12. 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.

  13. Pregnant or lactating women.
  14. There are any serious or uncontrollable systemic diseases, such as:

    Resting ECG has significant abnormalities in rhythm, conduction or morphology, and the symptoms are serious and difficult to control,such as complete left bundle branch block, heart block above degree Ⅱ, ventricular arrhythmia or atrial fibrillation;

    Unstable angina, congestive heart failure, chronic heart failure with NYHA grade ≥ 2;

    Within 6 months before inclusion, there were any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack etc;

    History of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose,or having currently clinical active interstitial lung diseases;

    Active pulmonary tuberculosis;

    Active or uncontrolled infections requiring systemic treatment;

    Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;

    Poorly controlled diabetes (Fasting blood glucose (FBG)>10mmol/L);

    Urine routine test indicates that urine protein≥++, and confirmed that 24 hours proteinuria>1.0 g;

    Patients with mental disorders who are unable to cooperate with the treatment;

  15. There are medical history, disease, treatment or laboratory abnormal results that may interfere with the test results, prevent the subjects from participating in the whole process of the study, or the researchers think that participating in the study is not in the best interests of the subjects or there are other potential risks that the subjects are not suitable for the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • 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.

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

  • 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.

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

Interventions

  • BiologicalSintilimab

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

    Also known as: IBI308, PD-1 antibody

  • DrugCarboplatin

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

  • DrugAlbumin-Bound Paclitaxel

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

06

What researchers measure

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.

    Time frame: At time of surgery

Secondary outcomes

  1. Pathology complete response rate(pCR)

    pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.

    Time frame: At time of surgery

  2. Objective response rate (ORR)

    ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.

    Time frame: prior to surgery

  3. 2 years disease-free survival rate (DFS)

    2 years DFS rate is defined as the percentage of participants having no recurrence, distant metastasis or death within 2 years after operation.

    Time frame: 2 years postoperatively

  4. 2 years overall survival rate (OS)

    2 years OS rate is defined as the percentage of participants having no death of any cause within 2 years after operation.The Kaplan-Meier estimator will be used to estimate median OS and its 95%CI and the survival curve.

    Time frame: 2 years postoperatively

  5. 2 years event free survival (EFS)

    2 years EFS rate is defined as the percentage of participants having no radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause within 2 years after randomization.

    Time frame: 2 years after randomization

07

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    • Fuming Qiu, PhD · Contact · qiufuming@zju.edu.cn · 13858005908
    • Junqiang Fan, PhD · Principal investigator
    • Fuming Qiu, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05429463
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jun 23, 2022
Start date
Nov 11, 2022
Primary completion
Nov 11, 2025 (estimated)
Completion
Nov 11, 2029 (estimated)
Last update
Dec 14, 2022

Study contacts

Fuming Qiu
Contact
qiufuming@zju.edu.cn
13858005908

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion