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

Primary Purpose

Lung Cancer Metastatic

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Radiotherapy

rhGM-CSF

About this trial

This is an interventional treatment trial for Lung Cancer Metastatic

Eligibility Criteria

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

Inclusion Criteria:

Age ≥18 years;
Histologically proven non-small-cell lung cancer；
Stage IV according to UICC stage system(version 7,2009), at least with three evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
ECOG performance status: 0-1;
Life expectancy ≥ 3 months.
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;
Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria:

Having received immunotherapy within 4 weeks prior to inclusion;
Allergic to GM-CSF, or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;
receiving treatment of other trials;
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;
unwilling to sign consent;
Women in pregnancy or lactation;
Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Sites / Locations

Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy and rhGM-CSF

Arm Description

Patients with metastatic non-small cell lung cancer received 3.5 Gy per fraction to a total dose of 35 Gy/ 10 fractions over 2 weeks, combined with rhGM-CSF (125 μg/m2).

Outcomes

Primary Outcome Measures

The abscopal effect rate

The proportion of patients with an abscopal response assessed after the initiation of treatment

Secondary Outcome Measures

Progression free survival

From the date of enrollment to the date of progression or death

Overall survival

From the date of enrollment to the date of death or last follow-up

Full Information

NCT ID

NCT03113851

First Posted

April 4, 2017

Last Updated

June 12, 2023

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03113851

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 14, 2017 (Actual)

Primary Completion Date

August 14, 2018 (Actual)

Study Completion Date

October 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

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

Lung Cancer Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy and rhGM-CSF

Arm Type

Experimental

Arm Description

Patients with metastatic non-small cell lung cancer received 3.5 Gy per fraction to a total dose of 35 Gy/ 10 fractions over 2 weeks, combined with rhGM-CSF (125 μg/m2).

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

radiation

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

rhGM-CSF

Other Intervention Name(s)

recombinant human GM-CSF

Intervention Description

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

Primary Outcome Measure Information:

Title

The abscopal effect rate

Description

The proportion of patients with an abscopal response assessed after the initiation of treatment

Time Frame

up to 50 months

Secondary Outcome Measure Information:

Title

Progression free survival

Description

From the date of enrollment to the date of progression or death

Time Frame

up to 84 months

Title

Overall survival

Description

From the date of enrollment to the date of death or last follow-up

Time Frame

up to 84 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years; Histologically proven non-small-cell lung cancer； Stage IV according to UICC stage system(version 7,2009), at least with three evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）; Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites); ECOG performance status: 0-1; Life expectancy ≥ 3 months. 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; Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential; Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites; Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites. Exclusion Criteria: Having received immunotherapy within 4 weeks prior to inclusion; Allergic to GM-CSF, or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one; receiving treatment of other trials; 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; unwilling to sign consent; Women in pregnancy or lactation; Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anhui Shi, MD.

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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