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Non-small Cell Lung CancerPhase 2NCT04612673

A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLC

A Phase 2 study testing Sintilimab in people with Non-small Cell Lung Cancer, run by China Medical University, China 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study is to to explore the efficacy and safety of PD-1 immune check point inhibitor, sintilimab, in biomarker-selected subjects with advanced or metastatic Non-small Cell Lung Cancer who have failed from standard front-line treatment. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
20 Nov 2020to 31 Dec 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 and ≤ 70 years of age , regardless of gender；
  • Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC (according to the eighth edition of AJCC staging, IIIB, IIIC, IV), with at least one measurable lesion (RECIST 1.1)
  • treatment failure after first-line standard treatment (definition of treatment failure: intolerable side effects, disease progression during or after treatment);
  • No known EGFR sensitive mutations and ALK gene rearrangements.
  • Tumor tissue samples that meet the testing requirements for biomarker testing can be provided. Testing will be carried out in the central laboratory.
  • NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive(TPS PD-L1 expression is ≥1% ), and CD8 expression is ≥20% (pre-treatment samples are sufficient).
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  • ECOG PS: 0-1
  • Sufficient organ and bone marrow function as defined below:
  • Routine blood examination:
  • HB≥90g/L;
  • ANC ≥1.5×109/L;
  • PLT ≥90×109/L;
  • Biochemical inspection shall:
  • Total bilirubin ≤ 1.5 ULN;
  • ALT and AST≤2.5ULN;
  • Serum Cr≤1ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft-Gault);
  • The international normalized ratio (INR) ≤ 1.5 and partial prothrombin time (PPT or APTT) ≤ 1.5 ULN within the 7 days before enrollment.
  • Life span expectation over 3 months;
  • Provide written informed consent;

Who cannot join

  • Allergic to any ingredients of Sintilimab preparations; or have had severe allergic reactions to other monoclonal antibodies in the past.
  • Received more than one regimen for the treatment of locally advanced or metastatic NSCLC in the past (except for adjuvant/neoadjuvant chemotherapy that has exceeded the 24-week).
  • Received any anti-PD-1/PD-L1 antibody, anti-CTLA4 antibody, or other immunotherapy in the past.
  • Diagnosed other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma and/or radically excised carcinoma in situ.
  • Be treated with anti-tumor vaccines or other immunostimulatory anti-tumor drugs (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before enrolled.
  • Central nervous system metastasis with symptoms..
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  • Acute or chronic active hepatitis B (defined as positive for hepatitis B virus surface antigen HBsAg during the screening period) or hepatitis C infection.
  • History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases.
  • Active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before the first administration.
  • People infected with human immunodeficiency virus (HIV) (HIV antibody positive), people with known syphilis infection.
  • Patients who are considered to be at greater medical risk due to severe, uncontrollable diseases, non-metastatic systemic diseases, or active, uncontrollable infections.
  • An active autoimmune disease that requires systemic treatment (such as the use
  • disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first administration.
  • Have used immunosuppressive drugs within 4 weeks before the first administration, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie not more than 10 mg/day prednisone Loose or equivalent doses of other glucocorticoids), allowing temporary use of glucocorticoids for the treatment of asthma, chronic obstructive pulmonary disease and other diseases such as dyspnea symptoms.
  • Exclude subjects who are expected to require any other form of anti-tumor therapy (including maintenance therapy with other NSCLC drugs, radiotherapy, and/or surgical resection) in the study.
  • Exclude those who underwent major surgery within 4 weeks before the first medication, those with non-thoracic radiation therapy >30 Gy within 4 weeks before the first medication, those with chest radiation >30 Gy within 24 weeks before the first medication, and 2 before the first medication Subjects who received palliative radiation <30 Gy within a week and who failed to recover from the toxicity and/or complications of these interventions to NCI-CTC AE ≤ 1 degree (except for hair loss and fatigue). Palliative radiotherapy for symptom control is permitted and must be completed at least 2 weeks before the start of treatment with the study drug, and there are no plans for additional radiotherapy to the same lesion. For patients who received radiotherapy 2 weeks before the first administration, all of the following conditions must be met before they can be enrolled: There is no radiotherapy-related toxic reaction, glucocorticoids are not required, and radiation pneumonitis, radiation hepatitis, radioactivity are excluded Enteritis and so on.
  • Pregnancy or lactation.
  • Participated in other drug clinical trials within four weeks.
  • The investigator believes that there are any conditions that may damage the subject or result in the subject not being able to meet or perform the research request.

Trial locations and contacts

1 site in 1 country.

Shuo Wang, PhD contact

0086-024-83281806

suresure_wang@163.com

China1 site

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

Other trials in China

About this study

Official title: Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Advanced or Metastatic Non-small Cell Lung Cancer Patients : a Phase II, Historical Control, Biomarker-selected Study

The purpose of this study is to to explore the efficacy and safety of PD-1 immune check point inhibitor, sintilimab, in biomarker-selected subjects with advanced or metastatic Non-small Cell Lung Cancer who have failed from standard front-line treatment.

Read the detailed description

This study is planned to be carried out in The First Hospital of China Medical University. 33 cases are preliminarily expected to be included. The study started in October 2020 and ended in October 2023. It is expected that the trial will end in October 2023.

In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.

Being tested
Sintilimab
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

    immune checkpoint inhibitor, 200mg, iv, d1,Q3W

Study groups in NCT04612673
Study groupRoleWhat they receive
TreatmentExperimentalParticipants received Sintilimab, 200mg, iv, d1, Q3W,and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Receives: Drug: Sintilimab

What is being measured

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

  1. Progress free survival (PFS)

    PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

    Measured: untill Progressive Disease(PD) or death(up to 24 months)

Secondary outcomes (3)

  1. Overall Survival (OS)

    OS is defined as the time until death due to any cause.

    Measured: From randomization until death (up to 24 months)

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  3. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 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 Nov 2020
  2. Study start20 Nov 2020 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Dec 2022 (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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04612673
Sponsor's protocol ID
CIBI308Y035
Status last verified
Oct 2020
First submitted
28 Oct 2020
Last updated
3 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab in people with Non-small Cell Lung Cancer, run by China Medical University, China 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 19 inclusion and 19 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 Nov 2020. 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?

Contact Shuo Wang, PhD (0086-024-83281806, suresure_wang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress free survival (PFS) (time frame: untill Progressive Disease(PD) or death(up to 24 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 NCT04612673.

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 Nov 2020.

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