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Carcinoma, Non-Small-Cell LungPhase 2PRIORITYNCT06221462

Neoadjuvant Sintilimab Plus Anlotinib Therapy in IB-IIIB Resectable Non-small Cell Lung Cancer

A Phase 2 study testing Sintilimab and Anlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Ningbo No.2 Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective single-center, open-label, phase II study evaluating the efficacy of sintilimab plus anlotinib as a neoadjuvant regimen in the treatment of IB-IIIB resectable non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Sintilimab and Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Feb 2024to 1 Feb 2030
Phase
Phase 2
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

  • Providing written informed consent prior to initiating the study.
  • Regardless of sex, aged ≥18 years and ≤75 years.
  • Histologically confirmed NSCLC.
  • At least one radiologically measureable lesion according to response evaluation criteria in solid tumors version 1.1(RECIST V1.1).
  • Treatment-naïve IB-IIIB resectable NSCLC (American Joint Committee on Cancer 8th tumor-node-metastasis classification).
  • Epidermal growth factor receptor(EFGR)/anaplastic lymphoma kinase(ALK)/ROS proto-oncogene 1(ROS1) wild type NSCLC.
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  • Absence of bleeding risk.
  • Consent to surgical treatment.
  • Indication for surgery confirmed by surgeons.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Expected survival time more than 6 months.
  • Sufficient organ reserve, detailed as follows:(1) the absolute neutrophil count ≥1.5×109/L without the use of granulocyte colony-stimulating factor for the past 14 days prior to the first dose of study drugs;(2) platelet count ≥100×109/L without blood transfusion within the 2 weeks before the enrollment;(3) hemoglobin >9g/dL without recent usage of blood transfusion 14 days prior to the study;(4) total bilirubin ≤ 1.5 fold the upper limit of normal (ULN), or total bilirubin >1.5 fold ULN but direct bilirubin ≤ 1 fold ULN;(5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;(6) blood creatinine ≤ 1.5 fold ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60ml/min;(7) adequate coagulation function, defined by international normalized ratio (INR) or prothrombin time(PT) less than 1.5 fold ULN;(8) normal thyroid function defined by the normal range of thyroid-stimulating hormone (TSH); otherwise, abnormal level of TSH with normal range of T3(or Ft3) and Ft4;(8) cardiac enzyme profile within the normal limits (merely laboratory abnormity without clinical significance based on investigator's decision is allowed)
  • For female participants of childbearing age, a urine or serum pregnancy test should be performed within 3 days before receiving the first dose of the study drugs, and the result must be negative. If the urine pregnancy test result is inconclusive, a blood pregnancy test is warranted. Postmenopausal women are defined as those who have been without menstruation for at least 1 year, or have undergone surgical sterilization or hysterectomy.
  • In the presence of pregnancy risk, all participants (both male and female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period up to 120 days following the last dose of the study drugs.

Who cannot join

  • Other malignancy rather than NSCLC diagnosed within 5 years prior to the first dose of the study given, except for definitively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma.
  • Enrolled in an ongoing interventional clinical trial, or receiving other study drugs or study medical devices within 4 weeks prior to the first dose of this study drugs.
  • A history of receiving the following therapies: anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death ligand-1 (anti-PD-L1) or anti-programmed cell death ligand-2 (anti-PD-L2) drugs, or drugs targeting T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4, tumor necrosis factor receptor superfamily member 4 and CD137).
  • A history of receiving targeted therapy such as anti-vascular endothelial growth receptor (VEGR)/ vascular endothelial growth factor receptor (VEGFR), rapidly accelerated fibrosarcoma(RAF), mitogen-activated protein kinase(MAPK), platelet-derived growth factor Receptor(PDGFR) or fibroblast growth factor receptor(FGFR).
  • Receiving traditional Chinese medication or immunomodulatory drugs (including thymopentin, interferon, interleukin, except for controlling pleural effusion) as systemic therapy within 2 weeks prior to the first dose of the study drugs.
  • Active systemic auto-immune disease requiring systemic treatment within 2 years prior to the first dose of the study drugs, such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered as systemic treatment.
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  • Systemic glucocorticoid therapy (excluding nasal, inhaled or other local routes of glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.
  • Undergoing allogeneic organ transplant (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplant.
  • Allergy to the active ingredient or excipients of the study drug, sintilimab.
  • Having not recovered from any toxicities and/or complications caused by prior interventions before the initiation of the study (i.e., ≤ Grade 1 or to baseline, excluding fatigue or hair loss)
  • Known history of human immunodeficiency virus (HIV) infection.
  • Untreated active hepatitis B (defined as hepatitis B surface antigen positive with detectable hepatitis B virus(HBV)-DNA copies exceeding the upper limit of normal values).
  • Active hepatitis C infection.
  • Receiving a live vaccine within 30 days prior to the first dose of the study drug.
  • Pregnant or lactating women.
  • Other investigator's defined uncontrolled systemic disease.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fajiu Wang, PhD contact

+86-574-83870605

wfjwyt@163.com

About this study

Official title: Neoadjuvant Sintilimab Plus Anlotinib Therapy in IB-IIIB Resectable Non-small Cell Lung Cancer (PRIORITY): a Prospective Single Center, Open Label, Phase II Study

This is a prospective single-center, open-label, phase II study evaluating the efficacy of sintilimab plus anlotinib as a neoadjuvant regimen in the treatment of IB-IIIB resectable non-small cell lung cancer.

Being tested
Sintilimab, Anlotinib
Keywords
non small cell lung cancer, Sintilimab, Anlotinib, neoadjuvant therapy
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.

  • SintilimabDrug

    200mg, every 3 weeks, 3 cycles, in the neoadjuvant setting, and adjuvant 200mg,every 3 weeks no more than one year

  • AnlotinibDrug

    8mg, orally, D1-14, every 3 weeks, 2 cycles in only neoadjuvant setting

Study groups in NCT06221462
Study groupRoleWhat they receive
treatment armExperimentalNot described
Receives: Drug: Sintilimab; Drug: Anlotinib

What is being measured

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

  1. major pathological response (MPR)

    Viable tumor cells are no more than 10% in the resected specimen

    Measured: 10 days postoperatively

Secondary outcomes (5)

  1. pathological complete response (pCR)

    Viable tumor cells are not found in the resected specimen

    Measured: 10 days postoperatively

  2. treatment-related adverse events (TRAEs)

    TRAEs including immune-related adverse reaction are documented and graded based on the US National Cancer Institute's Common Terminology Criteria for Adverse Events 5.0 criteria.

    Measured: 90 days after the last dose of study drugs

  3. disease-free survival (DFS)

    DFS is defined as the duration between the date of surgery and the date on which tumor recurrence is confirmed

    Measured: 5 years

  4. rate of operative complications

    The rate of surgical complications (such as bleeding, bronchopleural fistula,ect) are recorded and graded according to Clavien-Dindo criteria

    Measured: 30 days postoperatively

  5. overall survival(OS)

    OS is defined as the duration between the date of surgery and the date of all-cause death

    Measured: 5 years

Timeline

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

  1. First posted24 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion1 Feb 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221462
Sponsor's protocol ID
NBEY-HS-2023-008
Acronym
PRIORITY
Status last verified
Dec 2023
First submitted
26 Dec 2023
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab and Anlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Ningbo No.2 Hospital.

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 14 inclusion and 16 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: opening soon, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Contact Fajiu Wang, PhD (+86-574-83870605, wfjwyt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

major pathological response (MPR) (time frame: 10 days postoperatively). 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 NCT06221462.

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 25 Jan 2024.

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