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Squamous Cell Non-small Cell Lung CancerPhase 3neoSCORE ⅡNCT05429463

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

A Phase 3 study testing Sintilimab, Carboplatin and Albumin-Bound Paclitaxel in people with Squamous Cell Non-small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Squamous Cell Non-small Cell Lung Cancer
What is being tested?
Sintilimab, Carboplatin and Albumin-Bound Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteChina
Study dates
8 Dec 2022to 1 Aug 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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. If TSH levels are abnormal but triiodothyronine (T3) and thyroxine (T4) levels are within the normal range, and the patient is deemed eligible for the study treatment following evaluation by an endocrinologist, the patient can still be enrolled;
  • 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).

Who cannot join

  • 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).
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  • 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.
  • 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;
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

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

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.

Being tested
Sintilimab, Carboplatin, Albumin-Bound Paclitaxel
Keywords
Sintilimab, Squamous Cell NSCLC, Neoadjuvant immunochemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabBiological

    Also called IBI308, PD-1 antibody

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

  • CarboplatinDrug

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

  • Albumin-Bound PaclitaxelDrug

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

Study groups in NCT05429463
Study groupRoleWhat they receive
Arm A(3 cycles of neoadjuvant therapy)ExperimentalNeoadjuvant: 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.
Receives: Biological: Sintilimab; Drug: Carboplatin; Drug: Albumin-Bound Paclitaxel
Arm B(4 cycles of neoadjuvant therapy)ExperimentalNeoadjuvant: 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.
Receives: Biological: Sintilimab; Drug: Carboplatin; Drug: Albumin-Bound Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At time of surgery

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 2 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start8 Dec 2022
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05429463
Sponsor's protocol ID
neoSCORE Ⅱ
Acronym
neoSCORE Ⅱ
Status last verified
Aug 2026
First submitted
19 Jun 2022
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38353107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab, Carboplatin and Albumin-Bound Paclitaxel in people with Squamous Cell Non-small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response rate (MPR) (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05429463, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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