Non-Small Cell Lung Cancer MetastaticNCT03916913
TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC
A study testing Local radiation therapy in people with Non-Small Cell Lung Cancer Metastatic, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer Metastatic
- What is being tested?
- Local radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2023
- 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
- Age ≥18 and ≤75;
- ECOG performance status 0-1;
- Patients must provide study specific informed consent prior to study entry;
- Pathologically or cytologically diagnosed as NSCLC;
- EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;
- Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication;
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- Patients have received≥3 months of TKI therapy and do not received disease progression;
- HB ≥ 10.0 g/dL;
- Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L;
- Absolute number of PLT ≥ 100 × 109/L;
- Total bilirubin ≤ 1.5 folds of the maximum extent;
- ALT and AST ≤ 2.0 folds of the maximum extent;
- Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min.
Who cannot join
- Patients have received thoracic radiotherapy before;
- Malignant pleural effusion, pericardial effusion or peritoneal effusion;
- Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;
- Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease;
- HIV infection；
- Pregnancy or lactation women;
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- ECOG status ≥2；
- Mixed SCLC component;
- Other factors that is considered ineligible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jingbo Wang, Dr., 8610-87788503, wangjingbo303@yahoo.com
Luhua Wang, Dr., 8610-87788799, wlhwq@yahoo.com
About this study
Official title: Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial
In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
Read the detailed description
Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
- Conditions
- Non-Small Cell Lung Cancer Metastatic
- Being tested
- Local radiation therapy
- Keywords
- Non small cell lung cancer, Oligo-metastasis, EGFR activating mutation, Radiotherapy
- 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.
Local radiation therapyRadiation
Local radiotherapy on all sites of disease including primary and metastatic lesions
| Study group | Role | What they receive |
|---|---|---|
| Local therapy | Experimental | Consolidation local radiotherapy Receives: Radiation: Local radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Duration between the first date of TKI administration and disease progression or last follow-up
Measured: 1 year
Secondary outcomes (6)
Overall response
Post-RT response compared with the baseline status at the first data of TKI administration
Measured: 1 month after RT
Overall survival
Duration between the first date of TKI administration and any cause of death or last follow up
Measured: 2 year
Time to progression of initial lesions
Duration between the first date of TKI administration and the progression of the initial lesions or last follow up
Measured: 1 year
Time to appearance of new metastatic lesions
Duration between the first date of TKI administration and the occurrence of new lesions or last follow up
Measured: 1 year
Treatment related toxicity
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 1 year
EORTC Quality of life
Quality of life evaluation using EORTC questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer MetastaticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingbo Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jingbo Wang, MD, Principal investigator, Cancer Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916913
- Sponsor's protocol ID
- NCC201805002
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03916913
- Acronym / sponsor ID
- NCC201805002
- Conditions
- Non-Small Cell Lung Cancer Metastatic
- Keywords
- Non small cell lung cancer, Oligo-metastasis, EGFR activating mutation, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 16 Apr 2019 (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.
In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
Detailed description
Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Local therapy | Experimental | Radiation: Local radiation therapyConsolidation local radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 and ≤75;
- ECOG performance status 0-1;
- Patients must provide study specific informed consent prior to study entry;
- Pathologically or cytologically diagnosed as NSCLC;
- EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;
Key exclusion criteria (9 listed)
- Patients have received thoracic radiotherapy before;
- Malignant pleural effusion, pericardial effusion or peritoneal effusion;
- Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;
- Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease;
- HIV infection；
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 |
|---|---|---|
| Local radiation therapyLocal radiotherapy on all sites of disease including primary and metastatic lesions | Radiation | Local therapy |
Primary outcome
Progression free survival
Time frame: 1 year
Duration between the first date of TKI administration and disease progression or last follow-up
6 secondary outcomes
Overall response
Time frame: 1 month after RT
Overall survival
Time frame: 2 year
Time to progression of initial lesions
Time frame: 1 year
Time to appearance of new metastatic lesions
Time frame: 1 year
Treatment related toxicity
Time frame: 1 year
EORTC Quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Jingbo Wang, MD principal investigator
Cancer Hospital, CAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local radiation therapy in people with Non-Small Cell Lung Cancer Metastatic, run by Chinese Academy of Medical Sciences 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 13 inclusion and 9 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 Apr 2019. 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 Jingbo Wang, MD (+861087788056, wangjingbo303@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 1 year). 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 Apr 2019.