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

Phase 2

Completed

• Conditions: Lung Cancer Metastatic
• Interventions: Radiation: Radiotherapy; Drug: rhGM-CSF

• Registration Number: NCT03113851
• Lead Sponsor: Peking University Cancer Hospital & Institute

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).

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-08-14
• Primary Completion: 2018-08-14
• Study Completion: 2018-10-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy and rhGM-CSF	Radiotherapy	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).
Radiotherapy and rhGM-CSF	rhGM-CSF	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).

Primary Outcome Measures

Name	Time	Method
The abscopal effect rate	up to 50 months	The proportion of patients with an abscopal response assessed after the initiation of treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 84 months	From the date of enrollment to the date of death or last follow-up
Progression free survival	up to 84 months	From the date of enrollment to the date of progression or death

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China