AzTrials
AzTrials

Non-small Cell Lung CancerPhase 2neoSCORENCT04459611

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

A Phase 2 study testing sintilimab, pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
sintilimab, pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jul 2020to 1 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

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.
  • 18-75 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.
Show all 13Show fewer
  • 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.

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).
Show all 27Show fewer
  • 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.
  • 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 of Sintilimab Combined With Chemotherapy for Resectable NSCLC（neoSCORE）：A Prospective, Randomized, Open-Label, Single-Center Phase 2 Trial

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.

Read the detailed description

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. In this trial, eligible subjects will be randomly assigned to arm A and arm B (1:1). Subjects in arm A will receive 2 cycles of neoadjuvant chemotherapy with sintilimab + chemotherapy and arm B will receive 3 cycles of neoadjuvant chemotherapy with sintilimab + chemotherapy, followed by surgery within the 4th week after the last dose of sintilimab. After operation, subjects in arm A will receive 2 cycles of adjuvant chemotherapy and arm B will receive 1 cycle of adjuvant chemotherapy, followed by the maintenance treatment of sintilimab for up to 1 year according to the requirements of patients. The primary purpose is MPR rate of neoadjuvant chemotherapy of resectable NSCLC with different cycles of sintilimab combined with platinum-based chemotherapy, which is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.

Being tested
sintilimab, pemetrexed, Carboplatin, albumin-bound paclitaxel
Keywords
sintilimab, resectable NSCLC, neoadjuvant immunochemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

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.

  • pemetrexedDrug

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

  • CarboplatinDrug

    AUC 5 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 NCT04459611
Study groupRoleWhat they receive
sintilimab+chemotherapy(2 cycles of neoadjuvant chemotherapy)ExperimentalPatients 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.
Receives: Biological: sintilimab; Drug: pemetrexed; Drug: Carboplatin; Drug: albumin-bound paclitaxel
sintilimab+chemotherapy(3 cycles of neoadjuvant chemotherapy)ExperimentalPatients 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.
Receives: Biological: sintilimab; Drug: pemetrexed; 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 (4)

  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

Timeline

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

  1. First posted7 Jul 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Nov 2021
  4. Study completion1 Jul 2023 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459611
Sponsor's protocol ID
2020-KYY-518052-0092
Acronym
neoSCORE
Status last verified
Sep 2021
First submitted
2 Jul 2020
Last updated
12 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shao M, Yao J, Zhao L, Zhu L, Li B, Li L, Zhou B, Zhang Y, Liu H, Chen X, Wu Z, Chen Z, Fan J, Qiu F. Final Analysis of Neoadjuvant Sintilimab Plus Chemotherapy in IB-IIIA Non-Small-Cell Lung Cancer: Phase 2 neoSCORE Trial. Cancer Sci. 2026 Jun 7:10.1111/cas.70442. doi: 10.1111/cas.70442. Online ahead of print.

    PubMed 42252705

  • 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.

    PubMed 37032401

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sintilimab, pemetrexed and Carboplatin in people with 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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 NCT04459611, which also lists 2 linked publications.

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 12 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in