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NSCLC Stage IVPhase 2NCT04106180

SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC

A Phase 2 study testing GM-CSF, Sintilimab and SBRT in people with NSCLC Stage IV, run by Fudan University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is an open-label, multicenter, phase II single arm trial to evaluate the efficacy and safety of SBRT in combination with sintilimab and GM-CSF for the treatment of patients with advanced NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC Stage IV
What is being tested?
GM-CSF, Sintilimab and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteChina
Study dates
30 Sep 2019to 31 Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at least 18 years.
  • ECOG PS 0-1.
  • Pathologically confirmed stage IV NSCLC.
  • Negative for driver genes including EGFR，ALK，and ROS-1.
  • Patients with disease progression after first-line platinum-based therapy without anti-PD-1 or PD-L1 treatment.
  • Patients with at least one lesion (size 1-5cm) eligible for SBRT (24Gy/3Fx) and simultaneously at least one measurable lesion (in addition to the lesion treated with SBRT) as defined by RECIST1.1.
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  • Patients with brain metastasis are eligible if they are asymptomatic, neurologically stable, and off corticosteroids.
  • Life expectancy of more than 3 months.
  • Patients with no indications for palliative radiotherapy in the opinion of the investigator.
  • Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
  • Signed informed consent for the use of fresh tumor biopsies before and during the treatment.
  • Women of childbearing age and men must agree to use effective contraception during the trial.
  • Adequate organ function within 1 week prior to the enrollment：
  • Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, and platelet count ≥ 100 * 10 ^ 9/L;
  • Adequate hepatic function: total bilirubin < 1.5 x upper limit of normal (ULN). Note: If total bilirubin is > 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
  • Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;
  • Ability to understand and willingness to provide the informed consent.

Who cannot join

  • Prior exposure to immunomodulatory agent,including but limited to anti-PD-1 or anti-PD-L1 antibodies.
  • Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis) 、rheumatoid arthritis、scleroderma、systemic lupus erythematosus 、Wegener's granulomatosis and related vasculitides.
  • Patients receiving non-platinum-based chemotherapy as first-line treatment
  • Mixed small cell with non-small cell lung cancer histology.
  • Pregnant or lactating women.
  • Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis.
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  • History of any other malignancy.
  • Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
  • Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
  • Prior allergic reaction or contraindications to sintilimab and GM-CSF.
  • Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment. Note: Influenza vaccination is permitted only during influenza season, while live, attenuated influenza vaccine such as FluMist is not allowed.
  • Patients receiving concurrent chemotherapy drugs,other immunosuppressive agents,or other investigational treatment.Long-term corticosteroid users are also excluded.
  • Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

Zhengfei Zhu, MD contact

+86-18017312901

fuscczzf@163.com

Jianjiao Ni, MD contact

13761974092

nijianjiao8@sina.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Zhengfei Zhu, MD, +86-18017312901, fuscczzf@163.com

    Jianjiao Ni, MD, 13761974092, nijianjiao8@sina.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase II Single Arm Trial of SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC

This study is an open-label, multicenter, phase II single arm trial to evaluate the efficacy and safety of SBRT in combination with sintilimab and GM-CSF for the treatment of patients with advanced NSCLC.

Conditions
NSCLC Stage IV
Being tested
GM-CSF, Sintilimab, SBRT
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.

  • GM-CSFDrug

    Patients will receive GM-CSF 125μg/m2 daily for 14 consecutive days after completing SBRT treatment.

  • SintilimabDrug

    Patients will receive Sintilimab 200 mg every 3 weeks up to 2 years after completing SBRT treatment.

  • SBRTRadiation

    Also called Stereotactic body radiation therapy

    Patients will receive SBRT for one previously unirradiated primary or metastatic lesion (size: 1-5cm). 24 Gy in 3 fractions (8Gy/Fx) administered once-daily for 3 consecutive days.

Study groups in NCT04106180
Study groupRoleWhat they receive
SBRT + sintilimab + GM-CSFExperimentalNot described
Receives: Drug: GM-CSF; Drug: Sintilimab; Radiation: SBRT

What is being measured

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

  1. Overall Objective Response Rate

    ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Measured: At least 6 weeks after start of treatment

Secondary outcomes (4)

  1. Percentage of Participants With Adverse Events

    Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.

    Measured: Two years

  2. Objective Response Rate (ORR) in Non-irradiated Lesion

    Objective Response Rate (ORR) in Non-irradiated Lesion was defined as the proportion of patients with at least 30% reduction from baseline in the longest diameter of any of non-irradiated target lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time-point from the date of treatment initiation to the date of last follow-up.

    Measured: At least 6 weeks after start of treatment

  3. Overall Survival

    OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.

    Measured: Two years

  4. Progression Free Survival

    PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first.

    Measured: Two years

Timeline

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

  1. First posted26 Sep 2019
  2. Study start30 Sep 2019 (estimated)
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion31 Aug 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04106180
Sponsor's protocol ID
Sword
Status last verified
Sep 2019
First submitted
24 Sep 2019
Last updated
26 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ni J, Zhou Y, Wu L, Ai X, Dong X, Chu Q, Han C, Wang X, Zhu Z. Sintilimab, stereotactic body radiotherapy and granulocyte-macrophage colony stimulating factor as second-line therapy for advanced non-small cell lung cancer: safety run-in results of a multicenter, single-arm, phase II trial. Radiat Oncol. 2021 Sep 15;16(1):177. doi: 10.1186/s13014-021-01905-3.

    PubMed 34526044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GM-CSF, Sintilimab and SBRT in people with NSCLC Stage IV, run by Fudan University 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 17 inclusion and 13 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 26 Sep 2019. 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 Zhengfei Zhu, MD (+86-18017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Objective Response Rate (time frame: At least 6 weeks after start of treatment). 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 NCT04106180, which also lists 1 linked publication.

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 26 Sep 2019.

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