Clinical trial NCT03113851: Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer
Official title: Observation of Abscopal Effect of Radiation in Combination With rhGM-CSF for Patients With Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer Metastatic
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The abscopal effect rate
timeFrame: up to 50 months
Secondary outcomes:
measure: Progression free survival
timeFrame: up to 84 months
measure: Overall survival
timeFrame: up to 84 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Anhui Shi, MD.
role: PRINCIPAL_INVESTIGATOR
References: