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AzTrials

NSCLCPhase 2NCT02940990

SBRT in Multi-metastatic NSCLC Patients Which Are Pan-negative for Driver Mutations

A Phase 2 study testing SBRT concurrent with GM-CSF and two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel in people with NSCLC and SBRT, run by Shanghai Chest Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver mutations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, SBRT, GM-CSF
What is being tested?
SBRT concurrent with GM-CSF and two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteChina
Study dates
Nov 2016to Dec 2019
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

  • Histologically proven non-small-cell lung cancer.
  • Stage IV according to UICC stage system(version 7,2009).The number of metastatic lesions>5
  • Pan-negative for driver mutations including EGFR ALK ROS1 c-MET
  • At least Three evaluable lesions among which at least two must be suitable for SBRT.
  • ECOG performance status 0-2.
  • Expected lifespan ≥3 months.
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  • No brain metastasis in MRI.
  • No liver metastasis in abdominal CT or MRI.
  • No malignant pleural effusion or pericardial effusion from chest CT and/or pathology.
  • Stable lab values: Hematological:
  • Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels >1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels >1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.
  • Able to understand and give written informed consent and comply with study procedures.

Who cannot join

  • Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy.
  • Previously diagnosed with immunodeficiency disease.
  • Human immunodeficiency virus (HIV) infection.
  • Women in pregnancy or lactation .
  • Patients with mental illness, considered as "can't fully understand the issues of this research".
  • other Cancer history.
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  • Histologically confirmed small cell carcinoma or other non NSCLC compositions in the cancer tissue.
  • Brain metastasis or liver metastasis or malignant pleural effusion or pericardial effusion.
  • Allergy of rhGM-CSF and its accessories.
  • Contraindications to GM-CSF treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    Xiaolong Fu, PhD, +862122200000 ext. 3602, xlfu1964@126.com

Other trials in China

About this study

This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver mutations.

Read the detailed description

Lung cancer is the leading cause of cancer death. Forty percent of patients are diagnosed as metastatic lung cancer, and about 50% of them are pan-negative for driver mutations. The median overall survival(OS) for these patients is 11 months, and maintenance therapy can only prolong 2 months of OS. The NCCN guidelines recommend 4-6 cycles of chemotherapy with or without maintenance chemotherapy.

Published data showed that radiotherapy modulates tumor phenotypes, enhances antigen presentation and tumor immunogenicity. The regression of out-field lesions was termed as "abscopal effect". The combination of radiotherapy with immunotherapeutic agents may promote the host anti-tumor immune response and increase the rate of abscopal effect.Published data showed that abscopal effect appeared in 20%-30% patients with metastatic malignant tumors who were treated with the combination of SBRT and GM-CSF.

The investigators evaluate the efficacy of the combination of SBRT and GM-CSF in the multi-metastatic NSCLC participants who are pan-negative for driver mutations. Patients enrolled will be randomized into two groups. The control group will receive the standard regimen as NCCN recommends. The experimental group will receive both the standard chemotherapy and the extra SBRT to primary lesions or metastatic lesions combined with GM-CSF. The investigators compare progress free survival(PFS) of the two groups.

Conditions
NSCLC, SBRT, GM-CSF
Being tested
SBRT concurrent with GM-CSF, two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel

What participants receive

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

  • SBRT concurrent with GM-CSFRadiation

    SBRT and GM-CSF 125ug/m2 for 14 days

  • two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxelDrug

    two-drug regimen

Study groups in NCT02940990
Study groupRoleWhat they receive
Group APlacebo comparatorParticipants in the Group A will receive 4-6 cycles of standard two-drug chemotherapy. After that, clinical observation or maintenance chemotherapy will be given.
Receives: Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
Group BExperimentalParticipants in the Group B will also receive 4-6 cycles of standard two-drug chemotherapy. However, they will receive an additional treatment of SBRT to primary lesions or metastatic lesions combined with GM-CSF.
Receives: Radiation: SBRT concurrent with GM-CSF; Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel

What is being measured

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

  1. Progress Free Survival (PFS)

    Measured: 2 years

Secondary outcomes (2)

  1. Overall Survival （OS）

    Measured: 2 years

  2. Incidence of treatment-related adverse events

    Measured: 2 years

Timeline

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

  1. First posted21 Oct 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2019 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02940990
Sponsor's protocol ID
SCHLC007
Status last verified
Nov 2016
First submitted
18 Oct 2016
Last updated
1 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.

    PubMed 26095785

  • Bernstein MB, Krishnan S, Hodge JW, Chang JY. Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach? Nat Rev Clin Oncol. 2016 Aug;13(8):516-24. doi: 10.1038/nrclinonc.2016.30. Epub 2016 Mar 8.

    PubMed 26951040

  • Stamell EF, Wolchok JD, Gnjatic S, Lee NY, Brownell I. The abscopal effect associated with a systemic anti-melanoma immune response. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):293-5. doi: 10.1016/j.ijrobp.2012.03.017. Epub 2012 May 5.

    PubMed 22560555

  • Daly ME, Monjazeb AM, Kelly K. Clinical Trials Integrating Immunotherapy and Radiation for Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Dec;10(12):1685-93. doi: 10.1097/JTO.0000000000000686.

    PubMed 26484629

  • Abuodeh Y, Venkat P, Kim S. Systematic review of case reports on the abscopal effect. Curr Probl Cancer. 2016 Jan-Feb;40(1):25-37. doi: 10.1016/j.currproblcancer.2015.10.001. Epub 2015 Oct 9.

    PubMed 26582738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT concurrent with GM-CSF and two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel in people with NSCLC and SBRT, run by Shanghai Chest Hospital 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 12 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 Dec 2016. 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress Free Survival (PFS) (time frame: 2 years). 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 NCT02940990, which also lists 5 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 Dec 2016.

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