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Status unknownNCT03489616CRAGMOLCUpdated Apr 5, 2018

Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients

An interventional study of rhGM-CSF and Pemetrexed in Carcinoma, Non-Small-Cell Lung, sponsored by Shandong Cancer Hospital and Institute. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Shandong Cancer Hospital and Institute · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and rhGM-CSF is safe, effective in the treatment of oligometastatic stage IV NSCLC patients.

Read the detailed description

The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of oligometastatic stage IV NSCLC patients who were PR or SD after first-line chemotherapy，and to observe the abscopal effect, whether the scheme can improve PFS and OS.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
  2. Patients who were oligometastasis evaluated by PET-CT or other examinations after first-line chemotherapy. Eligible patients should have 2 to 5 distant metastases (at least 2 metastases were suitable for low fractionated radiotherapy). At least one distant measurable lesion outside the radiation sites.
  3. Age varied from 18 to 75 years old.
  4. ECOG performance status 0-2.
  5. Expected lifespan ≥3 months.
  6. Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L.
  7. Able to understand and give written informed consent and comply with study procedures.

Exclusion criteria

Exclusion criteria

  1. Allergy of rhGM-CSF and its accessories.
  2. Disease of systemic immune or immune disorders.
  3. Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue.
  4. Patients with thrombotic disease or platelets ≥600×109/L
  5. Cancer history within 5 years apart from NSCLC before enrollment.
  6. Tumor related immunotherapy within 4 weeks, including but not limited to immune cell therapy, tumor vaccine therapy, Immune checkpoint therapy, and other immunomodulators (such as thymosin, lentinan) except for rhGM-CSF.
  7. The abnormality of kidney , heart or lung functions（serum creatinine, Cr>177mol/L; serum AST or ALT more than 2 times above normal limits; total bilirubin, TBIL>34mol/L）.
  8. HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections.
  9. Women in pregnancy or lactation.
  10. Others who do not meet the inclusion criteria.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Radiotherapy+chemotherapy+ rhGM-CSF

    Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be\> 4Gy per time（or BED \>45Gy） from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.

    Biological: rhGM-CSF · Drug: Pemetrexed · Radiation: Local Radiotherapy · Drug: Single agent

  • Experimental
    Single agent maintenance therapy

    Maintenance treatment by single agent in a cycle of 21 days.

    Drug: Single agent

Interventions

  • BiologicalrhGM-CSF

    rhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability.

    Also known as: Recombinant human granulocyte macrophage stimulating factor

  • DrugPemetrexed

    Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.

  • RadiationLocal Radiotherapy

    Radiotherapy promotes the release of tumor antigen

    Also known as: Local Radiation therapy

  • DrugSingle agent

    Other chemotherapy drugs,such as Docetaxel, gemcitabine

    Also known as: Single agent for maintenance therapy

05

What researchers measure

Primary outcomes

  1. PFS

    Progression-Free-Survival

    Time frame: 2 years

Secondary outcomes

  1. Abscopal effect rate

    Radiotherapy-induced immune-mediated tumour regression at sites distant to the irradiated field

    Time frame: At the time point of 4 weeks after completion of rhGM-CSF

  2. OS

    Overall survival

    Time frame: 2 years

06

Study locations

2 of 2 sites recruiting
  • Shandong Cancer Hospital and Institute
    Jinan, Shandong 250000, China
    Recruiting
  • SHANDONG Cancer Hospital
    Jinan, Shandong 250000, China
    Recruiting
07

References and documents

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 ↗
  • Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24. PubMed 27789196 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03489616
Lead sponsor
Shandong Cancer Hospital and Institute
Responsible party
Jinming Yu (chief physician, Shandong Cancer Hospital and Institute) — Principal investigator
First posted
Apr 5, 2018
Start date
Jan 15, 2018
Primary completion
Jul 1, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Apr 5, 2018

Study contacts

Ming Huan Li, doctor
Contact
sy_lmh2001@163.com
131 5303 5389
JINMING YU, doctor
Contact
jn7984729@public.jn.sd.cn
13806406293 ext. 0531-87984729
JINMING YU, doctor
principal investigator · Shandong Cancer Hospital and Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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