NSCLCPhase 2NCT01941654
ATOM_local Ablative Therapy
A Phase 2 study testing preemptive local ablative therapy and Oral TKI in people with NSCLC and Activating EGFR Mutation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Activating EGFR Mutation
- What is being tested?
- preemptive local ablative therapy and Oral TKI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Sep 2013to 28 May 2020
- 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
- Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
- Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
- Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
- Not more than 4 residual metabolic active (SUVmax > 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
- The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
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- Age ≥ 18 years
- Pleural or pericardial effusion at diagnosis is allowed only if it has resolved on CT scan after 3-month EGFR TKI treatment
- Brain metastasis at diagnosis is allowed if it has been treated either surgically or with radiotherapy and there is no radiological progression on follow-up CT scan. The patient is neurologically stable for at least 1 week after cessation of steroid treatment
- Adequate organ function as defined by the following criteria:
- Serum alanine transaminase ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to liver metastases
- Total bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets count ≥ 100 x 109/L
- Creatinine clearance > 45ml/min
- Written informed consent that is consistent with ICH-GCP guidelines
Who cannot join
- Prior chemotherapy is not allowed except adjuvant chemotherapy for completely resected early staged non-small cell lung cancer and it has been at least 12 months before the start of EGFR TKI treatment
- Prior radiotherapy is not allowed except brain irradiation
- Leptomeningeal carcinomatosis
- Lymphangitis carcinomatosis of lung
- Prior or concomitant malignancy at other sites is not allowed except treated non-metastatic non-melanoma skin cancer, ductal carcinoma-in-situ of breast and carcinoma-in-situ of cervix with curative intent
- Uncontrolled active infection or medical condition (e.g. uncontrolled hypertension, unstable angina, congestive heart failure [≥ NYHA Class II], uncontrolled arrhythmia, myocardial infarction or cerebrovascular accident within the past 6 month)
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- Pre-existing interstitial lung disease
- Woman of child-bearing potential or male patient is unwilling to use adequate birth control method prior to the study entry, for the duration of study participation and for at least 2 months after the EGFR TKI treatment has ended.
- Pregnant and Lactating female patient
- Non-compliance to the study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm Phase II Study to Determine the Efficacy of Preemptive Local Ablative Therapy to Residual Metabolic Active Oligo-metastases in Those EGFR Mutation Positive Non-small Cell Lung Cancer Patients Who Have Achieved a Good Partial Response With First-line EGFR TKI (ATOM)
To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.
- Conditions
- NSCLC, Activating EGFR Mutation
- Being tested
- preemptive local ablative therapy, Oral TKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive local ablative therapyRadiation
Oral TKIDrug
| Study group | Role | What they receive |
|---|---|---|
| preemptive local ablative therapy | Experimental | Not described Receives: Radiation: preemptive local ablative therapy; Drug: Oral TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS rate at 1 year
Measured: 2 years
Secondary outcomes (4)
Overall survival
Measured: 2 years
Progression-free survival
Measured: 2 years
radiologic change on PET-CT scan 3 months after SABR
Measured: 3 months
Number of Participants with Adverse Events as a Measure of safety
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 posted13 Sep 2013 (estimated)
- Study start18 Sep 2013
- Primary completion31 Dec 2017
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Model description
- RT + Oral TKI
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Kwok Chi LAM, FRCP, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941654
- Sponsor's protocol ID
- LUN060
- Status last verified
- Jun 2020
- First submitted
- 3 Sep 2013
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Study to Determine the Efficacy of Preemptive Local Ablative Therapy to Residual Metabolic Active Oligo-metastases in Those EGFR Mutation Positive Non-small Cell Lung Cancer Patients Who Have Achieved a Good Partial Response With First-line EGFR TKI (ATOM)
- ClinicalTrials.gov ID
- NCT01941654
- Acronym / sponsor ID
- LUN060
- Conditions
- NSCLC, Activating EGFR Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Pamela Youde Nethersole Eastern Hospital
- Study start
- 18 Sep 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 13 Sep 2013 (estimated)
- 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.
To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RT + Oral TKI
| Arm | Type | Receives |
|---|---|---|
| preemptive local ablative therapy | Experimental | Radiation: preemptive local ablative therapy, Drug: Oral TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
- Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
- Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
- Not more than 4 residual metabolic active (SUVmax > 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
- The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
Key exclusion criteria (10 listed)
- Prior chemotherapy is not allowed except adjuvant chemotherapy for completely resected early staged non-small cell lung cancer and it has been at least 12 months before the start of EGFR TKI treatment
- Prior radiotherapy is not allowed except brain irradiation
- Leptomeningeal carcinomatosis
- Lymphangitis carcinomatosis of lung
- Prior or concomitant malignancy at other sites is not allowed except treated non-metastatic non-melanoma skin cancer, ductal carcinoma-in-situ of breast and carcinoma-in-situ of cervix with curative intent
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 |
|---|---|---|
| preemptive local ablative therapy | Radiation | preemptive local ablative therapy |
| Oral TKI | Drug | preemptive local ablative therapy |
Primary outcome
PFS rate at 1 year
Time frame: 2 years
4 secondary outcomes
Overall survival
Time frame: 2 years
Progression-free survival
Time frame: 2 years
radiologic change on PET-CT scan 3 months after SABR
Time frame: 3 months
Number of Participants with Adverse Events as a Measure of safety
Time frame: 2 years
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 18 Jun 2020.
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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.
Kwok Chi LAM, FRCP principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
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 preemptive local ablative therapy and Oral TKI in people with NSCLC and Activating EGFR Mutation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 16 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: finished, as of the sponsor's last update on 18 Jun 2020. 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 Hong Kong. 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?
PFS rate at 1 year (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 18 Jun 2020.