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Resectable Non-small Cell Lung CancerPhase 3NCT06485557

A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC

A Phase 3 study testing sintilimab plus platinum-based chemotherapy in people with Resectable Non-small Cell Lung Cancer, run by Tang-Du 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Non-small Cell Lung Cancer
What is being tested?
sintilimab plus platinum-based chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 1 Aug 2026
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol
  • Age ≥ 18 years
  • Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)
  • Subjects with Stage IIA (primary focus\>4cm), IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8), resectable N2 only refers to non-massive (defined as short diameter less than 3cm), discrete or single station N2 involvement.
  • No EGFR sensitive mutations and ALK rearrangements should be tested in non-squamous non-small cell lung cancer, and will be not mandatory in squamous cell carcinoma
  • Deemed radically resectable with curative intent
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  • Pulmonary function reached the standard of planned pneumonectomy ( FEV1 ≥ 50 % predicted value, MVV ≥ 50 % predicted value ), and there was no surgical contraindication
  • Enough tissue samples for PD-L1 detection (Number of slices ≥ 6)
  • At least one measurable lesion in line with RECIST V1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC
  • Have adequate organ and bone marrow function, and the laboratory examination values within 14 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin and other intravenous or subcutaneously administered drugs to correct hematological or liver and kidney dysfunction were allowed within the first 14 days of obtaining laboratory tests), as follows:
  • Hematological function was sufficient, defined as absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 100g / L;
  • Full liver function, defined as total bilirubin level ≤ 1.5 × ULN, AST and ALT level ≤ 2.5 × ULN, albumin (ALB) ≥ 35g / L;
  • Renal function was sufficient, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL / min (calculated by Cockcroft / Gault formula) and urine routine test results showed that urinary protein (UPRO) \< 2 + or 24-hour urinary protein \< 1g;
  • The international normalized ratio (INR) ≤ 1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN within 7 days before treatment;
  • For women of childbearing age, urine or serum pregnancy tests were negative for at least seven days prior to the first study drug administration. If the urine pregnancy test is positive, a blood pregnancy test is required;
  • If there is a risk of conception, male and female patients need to use high-efficiency contraception (i.e., the method with an annual failure rate of less than 1 %) and continue until at least 180 days after discontinuation of the trial; Note: If abstinence is the normal lifestyle and preferred contraceptive method of the subjects, abstinence can be accepted as a contraceptive method.

Who cannot join

  • Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components
  • Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body
  • pulmonary sulcus tumor
  • Contralateral lung nodules, it need biopsy if clinically suspected
  • Subjects with confirmed or suspected brain metastases
  • Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization
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  • Previous use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy
  • Received drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within the first 4 weeks of randomization
  • Received live attenuated vaccine within the first 4 weeks of randomization（Or plan to receive live attenuated vaccine during the study period） Note: Acceptance of inactivated vaccine for seasonal influenza is permitted; however, live attenuated influenza vaccine is not allowed
  • Need long-term systemic use of corticosteroids，received any other form of immunosuppressive therapy within 7 days before randomization Note: Nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (≤ 10mg / day prednisone or equal doses of drugs) or for pretreatment (such as prevention of contrast agent allergy) use is allowed
  • A history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease (≥ grade 2) within the previous year of randomization
  • Active autoimmune diseases, including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn \'s disease, that require systemic treatment ( such as the use of disease-modifying drugs, corticosteroids or immunosuppressants ), have occurred within the first two years of the randomization; diverticulitis; chylous diarrhea; systemic lupus erythematosus; sarcoidosis syndrome or wegener syndrome ( granuloma with polyangiitis); graves\' disease; rheumatoid arthritis; multiple sclerosis; vasculitis; glomerular nephritis; antiphospholipid syndrome; pituitary inflammation; uveitis, etc. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary dysfunction) are not considered as systemic treatments. Patients with positive autoimmune antibodies need to be evaluated by researchers to confirm that there is no autoimmune disease that requires systemic treatment before they can be enrolled
  • Primary immunodeficiency disease
  • Previous or current myocarditis
  • Not fully recovered from toxicity and/or complications caused by any intervention before randomization (> grade 1 or not recovery to baseline)
  • peripheral neuropathy ≥ grade 2
  • Hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis: There have been any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism.within the previous 6 months of randomization. Have a history of deep vein thrombosis or any other serious thromboembolism (implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis is not considered thromboembolism) within the previous 3 months of randomization
  • Non-squamous NSCLC subjects who were unable or unwilling to receive folic acid or vitamin B12 supplementation
  • Any unstable systemic disease or concurrent disease, including but not limited to:
  • 1）Active infection ( requiring anti-infective drugs or systemic anti-infective drugs used within the previous week of randomization ) ; 2）congestive heart failure [New York Heart Association, NYHA ≥ grade II]； 3）Severe arrhythmia, liver, kidney, or metabolic disease requiring medical treatment； 4）Untreated coronary atherosclerotic heart disease； 5）Have a history of gastrointestinal perforation and / or fistula, a history of intestinal obstruction, extensive bowel resection or long-term chronic diarrhea within the previous 6 months.
  • 20.Received solid organ or blood system transplantation
  • 21.Have a history of HIV infection (HIV1/2 antibody positive), active syphilis
  • 22.Tuberculosis, which is active or requires medical intervention at this stage, including but not limited to pulmonary tuberculosis
  • 23.Active Hepatitis B Subjects with hepatitis B who met the following criteria met the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load \< 2000 copies/ml or \< 200 IU/ml or lower than the detection limit HBsAg Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to closely monitor whether the virus is reactivated
  • 24.Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit)
  • 25.Patients with malignant tumors other than confirmed NSCLC within the first 5 years of randomization, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and thyroid papillary carcinoma after radical surgery
  • 26.Sintilimab and/or selected chemotherapy regimens (non-squamous NSCLC : pemetrexed plus cisplatin or carboplatin ; squamous NSCLC : Albumin paclitaxel plus cisplatin or carboplatin) active ingredients and/or any excipients have allergic reactions
  • 27.Pregnant or lactating women or women preparing to be pregnant or lactating during the study period
  • 28.Subjects are mental illness or drug abuse that may have an impact on compliance with the test requirements, and have a history of alcohol abuse
  • 29.Subjects with medical history, disease, treatment or laboratory abnormality which may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or the researchers believe that subjects in the study can not get the best interests of the subject Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, can lead to higher medical risks and/or uncertainty in survival evaluation.

Trial locations and contacts

No sites are listed yet.

Xiaolong Yan contact

8615991269383

yanxiaolong@fmmu.edu.cn

mingliang xing contact

15129745755

312596733@QQ.COM

About this study

This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles.

Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.

Read the detailed description

This study adopts a prospective cohort study design.The subjects will be randomly divided into three groups according to the ratio of 1:1:1 prior to surgery: group A, group B and group C. The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy, group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab, and group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab. Non-squamous NSCLC subjects will receive pemetrexed/albumin paclitaxel and platinum (cisplatin/carboplatin), and squamous NSCLC subjects will receive albumin paclitaxel and platinum (cisplatin / carboplatin).

Being tested
sintilimab plus platinum-based chemotherapy
Keywords
NSCLC, Neoadjuvant, Sintillumab

What participants receive

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

  • sintilimab plus platinum-based chemotherapyDrug

    Also called Group A

    The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy

  • sintilimab plus platinum-based chemotherapyDrug

    Also called Group B

    The subjects in group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab

  • sintilimab plus platinum-based chemotherapyDrug

    Also called Group C

    The subjects in group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab.

Study groups in NCT06485557
Study groupRoleWhat they receive
group AExperimentalreceive 3 cycles of sintilimab plus platinum-based chemotherapy
Receives: Drug: sintilimab plus platinum-based chemotherapy
group BExperimentalreceive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab
Receives: Drug: sintilimab plus platinum-based chemotherapy
group CExperimentalreceive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab
Receives: Drug: sintilimab plus platinum-based chemotherapy

What is being measured

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

  1. pCR rate

    rate of pathological complete response

    Measured: 4 months

Secondary outcomes (3)

  1. MPR rate

    rate of major pathologic response

    Measured: 4 months

  2. R0 resectability rate

    R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed

    Measured: 4 months

  3. The completion rate of surgery on schedule

    The rate of surgical completion as per the pre-established schedule represents a crucial metric in evaluating the efficiency and precision of medical institutions

    Measured: 4 months

Timeline

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

  1. First posted3 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Aug 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Prospective Cohort Study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485557
Sponsor's protocol ID
IIT20240507
Status last verified
Jul 2024
First submitted
20 Jun 2024
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect patient privacy

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sintilimab plus platinum-based chemotherapy in people with Resectable Non-small Cell Lung Cancer, run by Tang-Du 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 18 inclusion and 30 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 3 Jul 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 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?

Results are not available in the source record.

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

Contact Xiaolong Yan (8615991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate (time frame: 4 months). 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 NCT06485557.

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 3 Jul 2024.

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