Lung AdenocarcinomaPhase 2NCT02788058
A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy
A Phase 2 study testing EGFR-TKI and Thoracic Hypofractionated Radiotherapy in people with Lung Adenocarcinoma and EGFR Positive Non-small Cell Lung Cancer, run by First People's Hospital of Hangzhou.
Trial summary
To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma, EGFR Positive Non-small Cell Lung Cancer
- What is being tested?
- EGFR-TKI and Thoracic Hypofractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and became oligometastatic disease after 3 months TKI, evaluated by PET/CT scan, brain MRI, and abdomen ultrasound (≤6 discrete lesions of disease, exclusive of the brain metastases, ≤3 lesions in the liver, ≤3 lesions in the lung);
- All sites of disease must be amenable to definitive RT;
- An intrathoracic lymph nodal station is considered 1 discrete lesion, according to IASLC lymph nodal station map;
- Age 18 years or older;
- ECOG Performance Status 0-2;
- Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal;
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- For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment;
- Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;
- Patients and their family signed the informed consents;
Who cannot join
- Received chemotherapy before TKI therapy;
- Brain parenchyma or leptomeningeal disease;
- Any site of disease that is not amenable to definitive RT;
- Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment;
- Any medical co-morbidities that would preclude radiation therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Trial of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy
To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
Read the detailed description
Rational:
After inductive TKI therapy in NSCLC with sensitizing EGFR mutations, the residual lesion might be the source of subsequent disease progression, defined as acquired resistance to TKI. Two reasons can be used to explain the formation of the residual lesion：1）there is a subgroup of cancer cells that are not sensitive to TKI therapy because of tumor heterogeneity, like de novo T790M mutation; 2)some cancer cells can keep static state during the beginning treatment, and then develops acquired resistance to TKI therapy under the long-term drug pressure and continue to re-proliferation. From this point of view, elimination of residual lesion provides the chance to reduce or slow the possibility of developing resistance to TKI.
Objective:
To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
- Being tested
- EGFR-TKI, Thoracic Hypofractionated Radiotherapy
- Keywords
- Hypofractionated Radiotherapy, EGFR Positive, Lung Adenocarcinoma, Limited Metastases
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR-TKIDrug
Also called Gefitinib/Erlotinib/Icotinib
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Thoracic Hypofractionated RadiotherapyRadiation
40-45 Gy/5-15f
| Study group | Role | What they receive |
|---|---|---|
| EGFR-TKI | Experimental | Patients take EGFR-TKI alone till tumor progression Receives: Drug: EGFR-TKI |
| EGFR-TKI+hypofractionated radiotherapy | Active comparator | After 3 mos TKI, patients with limited metastatic take EGFR-TKI concurrent with hypofractionated radiotherapy till tumor progression. Receives: Drug: EGFR-TKI; Radiation: Thoracic Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 3 years
Secondary outcomes (8)
Frequency of T790M mutation before treatment detected by ctDNA
Measured: 1 months
Abundance of T790M mutation before treatment detected by ctDNA
Measured: 1 months
Frequency of T790M mutation after radiotherapy detected by ctDNA
Measured: 3 months
Abundance of T790M mutation after radiotherapy detected by ctDNA
Measured: 3 months
Frequency of T790M mutation after 1 year detected by ctDNA
Measured: 1 year
Abundance of T790M mutation after 1 year detected by ctDNA
Measured: 1 year
Rate of CTCAE grade 2 or higher radiation pneumonitis
We will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy.
Measured: 1 years
To assess the short-term quality of life (QOL)
FACT-E score at the 4 months after docetaxel consolidation therapy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788058
- Sponsor's protocol ID
- HZCH-2016-08
- Status last verified
- May 2016
- First submitted
- 22 Apr 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy
- ClinicalTrials.gov ID
- NCT02788058
- Acronym / sponsor ID
- HZCH-2016-08
- Keywords
- Hypofractionated Radiotherapy, EGFR Positive, Lung Adenocarcinoma, Limited Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 2 Jun 2016 (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 evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
Detailed description
Rational:
After inductive TKI therapy in NSCLC with sensitizing EGFR mutations, the residual lesion might be the source of subsequent disease progression, defined as acquired resistance to TKI. Two reasons can be used to explain the formation of the residual lesion：1）there is a subgroup of cancer cells that are not sensitive to TKI therapy because of tumor heterogeneity, like de novo T790M mutation; 2)some cancer cells can keep static state during the beginning treatment, and then develops acquired resistance to TKI therapy under the long-term drug pressure and continue to re-proliferation. From this point of view, elimination of residual lesion provides the chance to reduce or slow the possibility of developing resistance to TKI.
Objective:
To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGFR-TKI | Experimental | Drug: EGFR-TKIPatients take EGFR-TKI alone till tumor progression |
| EGFR-TKI+hypofractionated radiotherapy | Active comparator | Drug: EGFR-TKI, Radiation: Thoracic Hypofractionated RadiotherapyAfter 3 mos TKI, patients with limited metastatic take EGFR-TKI concurrent with hypofractionated radiotherapy till tumor progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and became oligometastatic disease after 3 months TKI, evaluated by PET/CT scan, brain MRI, and abdomen ultrasound (≤6 discrete lesions of disease, exclusive of the brain metastases, ≤3 lesions in the liver, ≤3 lesions in the lung);
- All sites of disease must be amenable to definitive RT;
- An intrathoracic lymph nodal station is considered 1 discrete lesion, according to IASLC lymph nodal station map;
- Age 18 years or older;
- ECOG Performance Status 0-2;
Key exclusion criteria (5 listed)
- Received chemotherapy before TKI therapy;
- Brain parenchyma or leptomeningeal disease;
- Any site of disease that is not amenable to definitive RT;
- Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment;
- Any medical co-morbidities that would preclude radiation therapy.
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 |
|---|---|---|
| EGFR-TKIAlso: Gefitinib/Erlotinib/IcotinibGefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid | Drug | EGFR-TKI, EGFR-TKI+hypofractionated radiotherapy |
| Thoracic Hypofractionated Radiotherapy40-45 Gy/5-15f | Radiation | EGFR-TKI+hypofractionated radiotherapy |
Primary outcome
Progression free survival
Time frame: 3 years
8 secondary outcomes
Frequency of T790M mutation before treatment detected by ctDNA
Time frame: 1 months
Abundance of T790M mutation before treatment detected by ctDNA
Time frame: 1 months
Frequency of T790M mutation after radiotherapy detected by ctDNA
Time frame: 3 months
Abundance of T790M mutation after radiotherapy detected by ctDNA
Time frame: 3 months
Frequency of T790M mutation after 1 year detected by ctDNA
Time frame: 1 year
Abundance of T790M mutation after 1 year detected by ctDNA
Time frame: 1 year
Rate of CTCAE grade 2 or higher radiation pneumonitis
Time frame: 1 years
To assess the short-term quality of life (QOL)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGFR-TKI and Thoracic Hypofractionated Radiotherapy in people with Lung Adenocarcinoma and EGFR Positive Non-small Cell Lung Cancer, run by First People's Hospital of Hangzhou.
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 9 inclusion and 5 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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenglin Ma, MD (0571-56007908 ext. 086, mashenglin@medmail.com.cn), 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: 3 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 2 Jun 2016.