Lung Cancer MetastaticPhase 2NCT03113851
Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing Radiotherapy and rhGM-CSF in people with Lung Cancer Metastatic, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Metastatic
- What is being tested?
- Radiotherapy and rhGM-CSF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2017to 14 Oct 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation of Abscopal Effect of Radiation in Combination With rhGM-CSF for Patients With Metastatic Non-small Cell Lung Cancer
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.
Read the 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).
- Conditions
- Lung Cancer Metastatic
- Being tested
- Radiotherapy, rhGM-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called radiation
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.
rhGM-CSFDrug
Also called recombinant human GM-CSF
Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy and rhGM-CSF | Experimental | 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). Receives: Radiation: Radiotherapy; Drug: rhGM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The abscopal effect rate
The proportion of patients with an abscopal response assessed after the initiation of treatment
Measured: up to 50 months
Secondary outcomes (2)
Progression free survival
From the date of enrollment to the date of progression or death
Measured: up to 84 months
Overall survival
From the date of enrollment to the date of death or last follow-up
Measured: up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start14 Aug 2017
- Primary completion14 Aug 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anhui Shi, MD, Peking University Cancer Hospital & Institute
- Investigators
- Anhui Shi, MD., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113851
- Sponsor's protocol ID
- 2016YJZ23
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2017
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Abscopal Effect of Radiation in Combination With rhGM-CSF for Patients With Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03113851
- Acronym / sponsor ID
- 2016YJZ23
- Conditions
- Lung Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 14 Apr 2017 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy and rhGM-CSF | Experimental | Radiation: Radiotherapy, Drug: rhGM-CSFPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| RadiotherapyAlso: radiationOne 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. | Radiation | Radiotherapy and rhGM-CSF |
| rhGM-CSFAlso: recombinant human GM-CSFPatients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy | Drug | Radiotherapy and rhGM-CSF |
Primary outcome
The abscopal effect rate
Time frame: up to 50 months
The proportion of patients with an abscopal response assessed after the initiation of treatment
2 secondary outcomes
Progression free survival
Time frame: up to 84 months
Overall survival
Time frame: up to 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Anhui Shi, MD. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy and rhGM-CSF in people with Lung Cancer Metastatic, run by Peking University Cancer Hospital & Institute at 1 site 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The abscopal effect rate (time frame: up to 50 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2023.