Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer

Lung Cancer Metastatic Clinical Trial

Official title:

Observation of Abscopal Effect of Radiation in Combination With rhGM-CSF for Patients With Metastatic Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113851
• Other study ID #: 2016YJZ23
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2017
• Est. completion date: October 14, 2018

Study information

• Verified date: June 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether radiation combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe and effective for patients with metastatic non-small cell lung cancer.

Description:

The prognosis of patients with metastatic non-small cell lung cancer was still poor for those unsuitable for target therapy or immunotherapy. This study is to include patients evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy to evaluate the efficacy and safety of receiving radiotherapy combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years;

2. Histologically proven non-small-cell lung cancer;

3. Stage IV according to UICC stage system(version 7,2009), at least with three evaluable abscopal lesions (=1cm)(excluding intestinal metastasis);

4. Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);

5. ECOG performance status: 0-1;

6. Life expectancy = 3 months.

7. Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per µL, platelet concentration of greater than 50 000 per µL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;

8. Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;

9. Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;

10. Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria:

1. Having received immunotherapy within 4 weeks prior to inclusion;

2. Allergic to GM-CSF, or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;

3. receiving treatment of other trials;

4. Any unstable systemic disease, including active infection, symptomatic congestive heart failure, myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;

5. unwilling to sign consent;

6. Women in pregnancy or lactation;

7. Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Related Conditions & MeSH terms

• Lung Cancer Metastatic
• Lung Neoplasms

Intervention

Radiation:
• Radiotherapy
One lesion received radiotherapy for 35 Gy in 10 fractions and rested for one week; then another metastatic lesion were treated with radiotherapy for 35 Gy in 10 fractions.

Drug:
• rhGM-CSF
Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The abscopal effect rate	The proportion of patients with an abscopal response assessed after the initiation of treatment	up to 50 months
Secondary	Progression free survival	From the date of enrollment to the date of progression or death	up to 84 months
Secondary	Overall survival	From the date of enrollment to the date of death or last follow-up	up to 84 months