Clinical trial · Interventional
Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer
Observation of Abscopal Effect of Radiation in Combination With rhGM-CSF for Patients With Metastatic Non-small Cell Lung Cancer
NCT03113851CI-TRIAL-00067123completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| rhGM-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy and rhGM-CSF
- 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).
- interventionNames
- Radiation: Radiotherapy
- Drug: rhGM-CSF
Primary outcomes (1)
- measure
- The abscopal effect rate
- timeFrame
- up to 50 months
- description
- The proportion of patients with an abscopal response assessed after the initiation of treatment
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.