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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03489616
• Other study ID #: SDCH201701LC
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2018
• Last updated: April 4, 2018
• Start date: January 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2018
• Source: Shandong Cancer Hospital and Institute
• Contact: Ming Huan Li, doctor
• Phone: 131 5303 5389
• Email: sy_lmh2001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Biological:
• rhGM-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.

Drug:
• Pemetrexed
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.

Radiation:
• Local Radiotherapy
Radiotherapy promotes the release of tumor antigen

Drug:
• Single agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine

Locations

Country	Name	City	State
China	SHANDONG Cancer Hospital	Jinan	Shandong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

References & 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 wi — View 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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-Free-Survival	2 years
Secondary	Abscopal effect rate	Radiotherapy-induced immune-mediated tumour regression at sites distant to the irradiated field	At the time point of 4 weeks after completion of rhGM-CSF
Secondary	OS	Overall survival	2 years