Clinical trial · Interventional
Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients
Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients Without Progression After First-line Chemotherapy: a Prospective Randomized Controlled Study
NCT03489616CI-TRIAL-00032355CRAGMOLCunknownN/AClinicalTrials.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 chemotherapy combination with local radiotherapy and rhGM-CSF is safe, effective in the treatment of oligometastatic stage IV NSCLC patients.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Radiotherapy | Radiation | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| rhGM-CSF | Biological | — | UNRESOLVED |
| Single agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy+chemotherapy+ rhGM-CSF
- description
- Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be\> 4Gy per time(or BED \>45Gy) from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
- interventionNames
- Biological: rhGM-CSF
- Drug: Pemetrexed
- Radiation: Local Radiotherapy
- Drug: Single agent
- type
- EXPERIMENTAL
- label
- Single agent maintenance therapy
- description
- Maintenance treatment by single agent in a cycle of 21 days.
- interventionNames
- Drug: Single agent
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy; 2. Patients who were oligometastasis evaluated by PET-CT or other examinations after first-line chemotherapy. Eligible patients should have 2 to 5 distant metastases (at least 2 metastases were suitable for low fractionated radiotherapy). At least one distant measurable lesion outside the radiation sites. 3. Age varied from 18 to 75 years old. 4. ECOG performance status 0-2. 5. Expected lifespan ≥3 months. 6. Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L. 7. Able to understand and give written informed consent and comply with study procedures. Exclusion criteria 1. Allergy of rhGM-CSF and its accessories. 2. Disease of systemic immune or immune disorders. 3. Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue. 4. Patients with thrombotic disease or platelets ≥600×109/L 5. Cancer history within 5 years apart from NSCLC before enrollment. 6. Tumor related immunotherapy within 4 weeks, including but not limited to immune cell therapy, tumor vaccine therapy, Immune checkpoint therapy, and other immunomodulators (such as thymosin, lentinan) except for rhGM-CSF. 7. The abnormality of kidney , heart or lung functions(serum creatinine, Cr\>177mol/L; serum AST or ALT more than 2 times above normal limits; total bilirubin, TBIL\>34mol/L). 8. HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections. 9. Women in pregnancy or lactation. 10. Others who do not meet the inclusion criteria.
References
Publications (2)
- RESULTGolden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18. PMID 26095785
- RESULTGomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24. PMID 27789196