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

NCT03489616 | Unknown DMC

• 1 other identifier: SDCH201701LC
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free-Survival

  2 years

Secondary Outcomes (2)

• Abscopal effect rate

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

• OS

  2 years

Study Arms (2)

Radiotherapy+chemotherapy+ rhGM-CSF

EXPERIMENTAL

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

Single agent maintenance therapy

EXPERIMENTAL

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

Drug: Single agent

Interventions

rhGM-CSF BIOLOGICAL

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

Radiotherapy+chemotherapy+ rhGM-CSF

Pemetrexed DRUG

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.

Radiotherapy+chemotherapy+ rhGM-CSF

Local Radiotherapy RADIATION

Radiotherapy promotes the release of tumor antigen

Also known as: Local Radiation therapy

Radiotherapy+chemotherapy+ rhGM-CSF

Single agent DRUG

Other chemotherapy drugs,such as Docetaxel, gemcitabine

Also known as: Single agent for maintenance therapy

Radiotherapy+chemotherapy+ rhGM-CSF; Single agent maintenance therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
• 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.
• Age varied from 18 to 75 years old.
• ECOG performance status 0-2.
• Expected lifespan ≥3 months.
• Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L.
• Able to understand and give written informed consent and comply with study procedures.

You may not qualify if:

• Allergy of rhGM-CSF and its accessories.
• Disease of systemic immune or immune disorders.
• Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue.
• Patients with thrombotic disease or platelets ≥600×109/L
• Cancer history within 5 years apart from NSCLC before enrollment.
• 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.
• 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）.
• HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections.
• Women in pregnancy or lactation.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (2)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250000, China

RECRUITING

SHANDONG Cancer Hospital

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26095785 RESULT

• 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.

  PMID: 27789196 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

regramostim; sargramostim; Pemetrexed; Pharmaceutical Preparations; Maintenance

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Health Care Facilities Workforce and Services

Study Officials

• JINMING YU, doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Huan Li, doctor

CONTACT

131 5303 5389; sy_lmh2001@163.com

JINMING YU, doctor

CONTACT

13806406293; jn7984729@public.jn.sd.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: January 15, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 31, 2019
• Last Updated: April 5, 2018

Record last verified: 2018-03

Locations

CN (2)