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Carcinoma, Non-Small-Cell LungPhase 2NCT05306847

Sintilimab Combined With Anlotinib Therapy for Initially Unresectable Non-small Cell Lung Cancer

A Phase 2 study testing Sintilimab and Anlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Peking Union Medical College Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Concurrent or sequential chemoradiotherapy has been recommended as the standard treatment for locally advanced and unresectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. 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
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
No sites listed yet
Study dates
1 Apr 2022to 1 Apr 2026
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

  • According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage II-III C) NSCLC confirmed by histology who are initially unable to undergo surgery and concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.
  • Age ≥18 years and ≤75 years.
  • ECOG PS score: 0 to 1.
  • The main organs function is normal, that is, the following criteria met:
  • Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109 /L, platelet count≥100 ×109 /L, hemoglobin ≥90g/L [no blood transfusion or no erythropoietin (EPO) dependence within 7 days before enrollment];
  • Biochemical test results should meet the following criteria: BIL < 1.25 times the upper limit of normal value (ULN); ALT and AST < 2.5 × ULN; in case of liver metastases, ALT and AST < 5 × ULN; Cr ≤1.5×ULN or creatinine clearance (CCr) ≥60ml/min; Coagulation function is good, INR and PT ≤1.5 × ULN;
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  • The oxygen saturation of the finger tip ≥ 92% both at rest and during walking (without oxygen inhalation).
  • The life expectancy ≥12 weeks.
  • Signed and dated informed consent.

Who cannot join

  • Subjects at risk of massive hemoptysis or with blood in sputum, including but not limited to tumor lesions no more than 5 mm away from large vessels, tumors invading large vessels, and obvious lung cavity/necrotizing tumors.
  • Small cell lung cancer (including mixed small cell and non-small cell lung cancer) or central squamous cell carcinoma.
  • With driver mutation (EGFR/ALK/ROS1).
  • With uncontrollable hypertension (systolic pressure > 160 mmHg, diastolic pressure > 100 mmHg) even receiving antihypertensive drug therapy.
  • Has an active autoimmune disease, history of allogeneic stem cell transplantation or organ transplantation that has required systemic treatment. Replacement therapy is not considered a form of systemic treatment and is allowed.
  • Has an active infection requiring systemic therapy.
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  • Has other malignant tumors (except radical cervical carcinoma in situ, non-melanoma skin cancer, etc.) or concomitant diseases that seriously endanger the patients or affect the patients completing the study at the same time.
  • With immunodeficiency status, including but not limited to HIV infection and primary immunodeficiency diseases.
  • Previously treated with ICIs.
  • Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.

Trial locations and contacts

No sites are listed yet.

Yingyi Wang, Professor contact

+86 010-69158764

wangyingyi@pumch.cn

About this study

Official title: Sintilimab Combined With Anlotinib Therapy for Patients With Initially Unresectable Stage II-III Non-small Cell Lung Cancer: A Prospective, Single-arm Study

Concurrent or sequential chemoradiotherapy has been recommended as the standard treatment for locally advanced and unresectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. PD-1/PD-L1 inhibitors have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents have also been used for the first-line treatment of advanced or metastatic NSCLC. Therefore, we designed this single-arm clinical trial, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC.

Read the detailed description

Concurrent or sequential chemoradiotherapy is the standard treatment for patients with locally advanced NSCLC, but patients receiving chemoradiotherapy have limited improvement in prognosis and are almost impossible to achieve a radical cure. Considering the excellent effect of immunotherapy and anti-angiogenesis therapy in NSCLC, we designed this single-arm clinical study, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC, in order to enable patients to achieve further surgical treatment and prolonged survival.

Being tested
Sintilimab, Anlotinib
Keywords
Non-small-cell lung cancer, Sintilimab, Anlotinib
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

    Also called IBI308, Tyvyt

    Sintilimab will be given intravenously at a dose of 200mg every 21 days.

  • AnlotinibDrug

    Also called Anlotinib hydrochloride, AL3818

    Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.

Study groups in NCT05306847
Study groupRoleWhat they receive
Experimental armExperimentalSintilimab will be given intravenously at a dose of 200mg every 21 days. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle. Tumor evaluation will be conducted after treatment of the tested regimen every 2 cycles. Subsequent treatment will be determined based on the evaluation results: If the patients are not suitable for radical surgery, but the result of efficacy evaluation is CR, PR, or SD, they can continue to receive the tested regimen. If the patients are still not suitable for radical surgery after 6 cycles of the tested regimen, the standard first-line or immunotherapy after chemoradiotherapy or radiotherapy will be given. If patients are eligible for radical surgery, surgery will be performed within 4 weeks after completion of the last tested regimen.
Receives: Drug: Sintilimab; Drug: Anlotinib

What is being measured

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

  1. Surgical conversion rate

    The surgical conversion rate was defined as the proportion of subjects with the successful conversion over all subjects who received the tested regime.

    Measured: 18 weeks from the initiation of the tested regime therapy

Secondary outcomes (8)

  1. Objective response rate (ORR)

    ORR is defined as the percentage of participants who have the best overall response (BOR) of complete response (CR) or partial response (PR) assessed based on RECIST 1.1.

    Measured: 18 weeks from the initiation of the tested regime therapy

  2. R0 resection rate

    R0 resection rate is defined as the complete resection rate of all tumor under microscope.

    Measured: within 28 working days after operation

  3. Major pathological response rate

    Major pathological response rate is defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%).

    Measured: within 28 working days after operation

  4. Pathological complete response rate

    Pathological complete response rate is defined as the percentage of patients who achieved a pathological complete response (residual tumor = 0%).

    Measured: within 28 working days after operation

  5. Overall survival (OS)

    OS is measured from the time from the treatment onset (date of first study dose) until the date of death from any cause.

    Measured: 2 years from the initiation of the tested regime therapy

  6. Progression-free survival (PFS)

    PFS is measured from the time from the treatment onset (date of first study dose) until the date of tumor progression or death from any cause.

    Measured: 2 years from the initiation of the tested regime therapy

  7. Disease-free survival (DFS)

    DFS is measured from the time from radical surgery until the date of tumor progression or death from any cause.

    Measured: 2 years from the initiation of the tested regime therapy

  8. Treatment-related adverse events

    Incidence and grade of treatment-related adverse events assessed based on CTCAE 5.0

    Measured: 3 months from the end of the tested regime therapy

Timeline

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

  1. First posted1 Apr 2022
  2. Study start1 Apr 2022 (estimated)
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 2026 (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
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05306847
Sponsor's protocol ID
HS-3340
Status last verified
Mar 2022
First submitted
21 Mar 2022
Last updated
1 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick S, Brahmer J, Swanson SJ et al: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as neoadjuvant treatment (tx) for resectable (IB-IIIA) non-small cell lung cancer (NSCLC) in the phase 3 CheckMate 816 trial. Cancer research 2021, 81(13 SUPPL).

  • Mery B, Guy JB, Swalduz A, Vallard A, Guibert C, Almokhles H, Ben Mrad M, Rivoirard R, Falk AT, Fournel P, Magne N. The evolving locally-advanced non-small cell lung cancer landscape: Building on past evidence and experience. Crit Rev Oncol Hematol. 2015 Nov;96(2):319-27. doi: 10.1016/j.critrevonc.2015.05.020. Epub 2015 Jun 7.

    PubMed 26095618

  • Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

    PubMed 33476803

  • De Ruysscher D, Botterweck A, Dirx M, Pijls-Johannesma M, Wanders R, Hochstenbag M, Dingemans AM, Bootsma G, Geraedts W, Simons J, Pitz C, Lambin P. Eligibility for concurrent chemotherapy and radiotherapy of locally advanced lung cancer patients: a prospective, population-based study. Ann Oncol. 2009 Jan;20(1):98-102. doi: 10.1093/annonc/mdn559. Epub 2008 Aug 20.

    PubMed 18718891

  • Xiao W, Hong M. Concurrent vs sequential chemoradiotherapy for patients with advanced non-small-cell lung cancer: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Mar 19;100(11):e21455. doi: 10.1097/MD.0000000000021455.

    PubMed 33725921

  • Eberhardt WE, Pottgen C, Gauler TC, Friedel G, Veit S, Heinrich V, Welter S, Budach W, Spengler W, Kimmich M, Fischer B, Schmidberger H, De Ruysscher D, Belka C, Cordes S, Hepp R, Lutke-Brintrup D, Lehmann N, Schuler M, Jockel KH, Stamatis G, Stuschke M. Phase III Study of Surgery Versus Definitive Concurrent Chemoradiotherapy Boost in Patients With Resectable Stage IIIA(N2) and Selected IIIB Non-Small-Cell Lung Cancer After Induction Chemotherapy and Concurrent Chemoradiotherapy (ESPATUE). J Clin Oncol. 2015 Dec 10;33(35):4194-201. doi: 10.1200/JCO.2015.62.6812. Epub 2015 Nov 2.

    PubMed 26527789

  • Deng H, Liu J, Cai X, Chen J, Rocco G, Petersen RH, Brunelli A, Ng CSH, D'Amico TA, Liang W, He J. Radical Minimally Invasive Surgery After Immuno-chemotherapy in Initially-unresectable Stage IIIB Non-small cell Lung Cancer. Ann Surg. 2022 Mar 1;275(3):e600-e602. doi: 10.1097/SLA.0000000000005233.

    PubMed 34596079

  • Chu T, Zhong R, Zhong H, Zhang B, Zhang W, Shi C, Qian J, Zhang Y, Chang Q, Zhang X, Dong Y, Teng J, Gao Z, Qiang H, Nie W, Zhao Y, Han Y, Chen Y, Han B. Phase 1b Study of Sintilimab Plus Anlotinib as First-line Therapy in Patients With Advanced NSCLC. J Thorac Oncol. 2021 Apr;16(4):643-652. doi: 10.1016/j.jtho.2020.11.026. Epub 2021 Jan 29.

    PubMed 33524601

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 Peking Union Medical College 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 9 inclusion and 10 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 1 Apr 2022. 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?

Results are not available in the source record.

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

Contact Yingyi Wang, Professor (+86 010-69158764, wangyingyi@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical conversion rate (time frame: 18 weeks from the initiation of the tested regime therapy). 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 NCT05306847, which also lists 8 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 1 Apr 2022.

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