Stage IV Non-small Cell Lung CancerNCT05583409
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
A study testing SBRT+Osimertinib and Osimertinib 80 MG in people with Stage IV Non-small Cell Lung Cancer, run by Li Zhang at 1 site in China.
Trial summary
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer
- What is being tested?
- SBRT+Osimertinib and Osimertinib 80 MG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Dec 2025
- 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
- Patients must have biopsy proven metastatic NSCLC (Stage IV).
- Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.
- Age 18 to 75 years old.
- Patients must have measurable disease at baseline.
- The amount of metastatic focus <5.
- ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy.
- 8. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) 9. Patients must provide written informed consent to participate in the study.
Who cannot join
- Patients who previously received radiotherapy to the primary site.
- Patient can't tolerate radiotherapy or targeted therapy;
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China
Wuhan, Hubei, 430030
About this study
Official title: Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Being tested
- SBRT+Osimertinib, Osimertinib 80 MG
- 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.
SBRT+OsimertinibRadiation
Received SBRT after three months of Osimertinib treatment
Osimertinib 80 MGDrug
Osimertinib 80mg, po, Qd
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib plus SBRT | Experimental | SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment Receives: Radiation: SBRT+Osimertinib |
| Osimertinib | Active comparator | Osimertinib 80mg, po, Qd Receives: Drug: Osimertinib 80 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
the time from the beginning of Osimertinib treatment to disease progression or death
Measured: 2 years
Secondary outcomes (1)
OS
the time from the beginning of Osimertinib treatment to death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Non-small Cell Lung CancerStudies 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
- Model description
- SBRT plus Osimertinib versus Osimertinib
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Cancer Hospital
- Responsible party
- Sponsor-investigator, Li Zhang, Tongji Hospital
- Investigators
- Li Zhang, MD,PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583409
- Sponsor's protocol ID
- TJCC-LC002
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05583409
- Acronym / sponsor ID
- TJCC-LC002
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Li ZhangUniversity, hospital or other
- Collaborators
- Hubei Cancer Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 17 Oct 2022 (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.
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SBRT plus Osimertinib versus Osimertinib
| Arm | Type | Receives |
|---|---|---|
| Osimertinib plus SBRT | Experimental | Radiation: SBRT+OsimertinibSBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment |
| Osimertinib | Active comparator | Drug: Osimertinib 80 MGOsimertinib 80mg, po, Qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have biopsy proven metastatic NSCLC (Stage IV).
- Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.
- Age 18 to 75 years old.
- Patients must have measurable disease at baseline.
- The amount of metastatic focus <5.
Key exclusion criteria (3 listed)
- Patients who previously received radiotherapy to the primary site.
- Patient can't tolerate radiotherapy or targeted therapy;
- Pregnant or nursing women
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 |
|---|---|---|
| SBRT+OsimertinibReceived SBRT after three months of Osimertinib treatment | Radiation | Osimertinib plus SBRT |
| Osimertinib 80 MGOsimertinib 80mg, po, Qd | Drug | Osimertinib |
Primary outcome
PFS
Time frame: 2 years
the time from the beginning of Osimertinib treatment to disease progression or death
1 secondary outcome
OS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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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.
Li Zhang, MD,PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT+Osimertinib and Osimertinib 80 MG in people with Stage IV Non-small Cell Lung Cancer, run by Li Zhang 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 7 inclusion and 3 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 17 Oct 2022. 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.
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 Li Zhang, MD,PhD (02783663407, luzigang@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?
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 17 Oct 2022.