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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

rhGM-CSF

Pemetrexed

Local Radiotherapy

Single agent

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion criteria

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.
Others who do not meet the inclusion criteria.

Sites / Locations

Shandong Cancer Hospital and InstituteRecruiting
SHANDONG Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Radiotherapy+chemotherapy+ rhGM-CSF

Single agent maintenance therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

PFS

Progression-Free-Survival

Secondary Outcome Measures

Abscopal effect rate

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

Overall survival

Full Information

NCT ID

NCT03489616

First Posted

March 29, 2018

Last Updated

April 4, 2018

Sponsor

Shandong Cancer Hospital and Institute

1. Study Identification

Unique Protocol Identification Number

NCT03489616

Brief Title

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

Acronym

CRAGMOLC

Official Title

Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients Without Progression After First-line Chemotherapy: a Prospective Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 15, 2018 (Actual)

Primary Completion Date

July 1, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Cancer Hospital and Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy+chemotherapy+ rhGM-CSF

Arm Type

Experimental

Arm Description

Arm Title

Single agent maintenance therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

rhGM-CSF

Other Intervention Name(s)

Recombinant human granulocyte macrophage stimulating factor

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Local Radiotherapy

Other Intervention Name(s)

Local Radiation therapy

Intervention Description

Radiotherapy promotes the release of tumor antigen

Intervention Type

Drug

Intervention Name(s)

Single agent

Other Intervention Name(s)

Single agent for maintenance therapy

Intervention Description

Other chemotherapy drugs,such as Docetaxel, gemcitabine

Primary Outcome Measure Information:

Title

PFS

Description

Progression-Free-Survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Abscopal effect rate

Description

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

Title

Description

Overall survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion criteria 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. Others who do not meet the inclusion criteria.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Huan Li, doctor

Phone

131 5303 5389

sy_lmh2001@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

JINMING YU, doctor

Phone

13806406293

Ext

0531-87984729

jn7984729@public.jn.sd.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JINMING YU, doctor

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shandong Cancer Hospital and Institute

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MINGHUAN LI, Doctor

Phone

13153035389

Ext

0531-67626112

Sy_lmh2001@163.com

First Name & Middle Initial & Last Name & Degree

JIMING YU, Doctor

Phone

13806406293

Ext

0531-87984729

jn7984729@public.jn.sd.cn

Facility Name

SHANDONG Cancer Hospital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26095785

Citation

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.

Results Reference

result

PubMed Identifier

27789196

Citation

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.

Results Reference

result

Learn more about this trial

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

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