Carcinoma, Non-Small-Cell LungCRAGMOLCNCT03489616
Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients
A study testing rhGM-CSF, Pemetrexed and Local Radiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Shandong Cancer Hospital and Institute at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- rhGM-CSF, Pemetrexed and Local Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
- 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.
- Age varied from 18 to 75 years old.
- ECOG performance status 0-2.
- Expected lifespan ≥3 months.
- Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L.
- Able to understand and give written informed consent and comply with study procedures.
Who cannot join
- Allergy of rhGM-CSF and its accessories.
- Disease of systemic immune or immune disorders.
- Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue.
- Patients with thrombotic disease or platelets ≥600×109/L
- Cancer history within 5 years apart from NSCLC before enrollment.
- 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.
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- 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）.
- HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections.
- Women in pregnancy or lactation.
- Others who do not meet the inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250000
MINGHUAN LI, Doctor, 13153035389 ext. 0531-67626112, Sy_lmh2001@163.com
JIMING YU, Doctor, 13806406293 ext. 0531-87984729, jn7984729@public.jn.sd.cn
- Recruiting
SHANDONG Cancer Hospital
Jinan, Shandong, 250000
About this study
Official title: 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
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.
Read the detailed description
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of oligometastatic stage IV NSCLC patients who were PR or SD after first-line chemotherapy，and to observe the abscopal effect, whether the scheme can improve PFS and OS.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- rhGM-CSF, Pemetrexed, Local Radiotherapy, Single agent
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGM-CSFBiological
Also called Recombinant human granulocyte macrophage stimulating factor
rhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability.
PemetrexedDrug
Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
Local RadiotherapyRadiation
Also called Local Radiation therapy
Radiotherapy promotes the release of tumor antigen
Single agentDrug
Also called Single agent for maintenance therapy
Other chemotherapy drugs,such as Docetaxel, gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy+chemotherapy+ rhGM-CSF | Experimental | 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. Receives: Biological: rhGM-CSF; Drug: Pemetrexed; Radiation: Local Radiotherapy; Drug: Single agent |
| Single agent maintenance therapy | Experimental | Maintenance treatment by single agent in a cycle of 21 days. Receives: Drug: Single agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free-Survival
Measured: 2 years
Secondary outcomes (2)
Abscopal effect rate
Radiotherapy-induced immune-mediated tumour regression at sites distant to the irradiated field
Measured: At the time point of 4 weeks after completion of rhGM-CSF
OS
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start15 Jan 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- JINMING YU, doctor, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489616
- Sponsor's protocol ID
- SDCH201701LC
- Acronym
- CRAGMOLC
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Golden 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.
PubMed 26095785Gomez 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.
PubMed 27789196
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03489616
- Acronym / sponsor ID
- CRAGMOLC / SDCH201701LC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of oligometastatic stage IV NSCLC patients who were PR or SD after first-line chemotherapy，and to observe the abscopal effect, whether the scheme can improve PFS and OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy+chemotherapy+ rhGM-CSF | Experimental | Biological: rhGM-CSF, Drug: Pemetrexed, Radiation: Local Radiotherapy, Drug: Single agentPatients 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. |
| Single agent maintenance therapy | Experimental | Drug: Single agentMaintenance treatment by single agent in a cycle of 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
- 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.
- Age varied from 18 to 75 years old.
- ECOG performance status 0-2.
- Expected lifespan ≥3 months.
Key exclusion criteria (10 listed)
- Allergy of rhGM-CSF and its accessories.
- Disease of systemic immune or immune disorders.
- Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue.
- Patients with thrombotic disease or platelets ≥600×109/L
- Cancer history within 5 years apart from NSCLC before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhGM-CSFAlso: Recombinant human granulocyte macrophage stimulating factorrhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability. | Biological | Radiotherapy+chemotherapy+ rhGM-CSF |
| PemetrexedPemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer. | Drug | Radiotherapy+chemotherapy+ rhGM-CSF |
| Local RadiotherapyAlso: Local Radiation therapyRadiotherapy promotes the release of tumor antigen | Radiation | Radiotherapy+chemotherapy+ rhGM-CSF |
| Single agentAlso: Single agent for maintenance therapyOther chemotherapy drugs,such as Docetaxel, gemcitabine | Drug | Radiotherapy+chemotherapy+ rhGM-CSF, Single agent maintenance therapy |
Primary outcome
PFS
Time frame: 2 years
Progression-Free-Survival
2 secondary outcomes
Abscopal effect rate
Time frame: At the time point of 4 weeks after completion of rhGM-CSF
OS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Results publication: PubMed 26095785Golden 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.
- Results publication: PubMed 27789196Gomez 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JINMING YU, doctor principal investigator
Shandong Cancer Hospital and Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhGM-CSF, Pemetrexed and Local Radiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Shandong Cancer Hospital and Institute at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Huan Li, doctor (131 5303 5389, sy_lmh2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.