Lung Cancer Stage IVPhase 2NCT03153358
Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation
A Phase 2 study testing Icotinib and SBRT in people with Lung Cancer Stage IV, run by Sichuan Cancer Hospital and Research Institute.
Trial summary
Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine kinase inhibitors experience limited sites of disease progression. For multiple metastases in patients with advanced NSCLC, increased local treatment may benefit to prolong patient survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer Stage IV
- What is being tested?
- Icotinib and SBRT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2017to 2 May 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation.
- Stage disease according to the 7th Edition of the American Joint Committee on Cancer staging system
- Not received radiotherapy, chemotherapy or other biological treatment
- Measureable disease
- Life expectancy of>=12 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
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- Absolute neutrophil count (ANC)>=2,500/mm^3
- Hemoglobin>=9.0 g/dL
- Total bilirubin<=1.5 x upper limit of normal(ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine transferase [ALT])<=2.5 x ULN in patients without liver or bone metastases; <5 x ULN in patients with liver or bone metastases
- Cockcroft-Gault calculated creatinine clearance of>=45 ml/min or creatinine<=1.5 x ULN
- Prothrombin time (PT)<=1.5 x ULN
- Partial thromboplastin time (PTT)<=ULN
- Negative pregnancy test done<=7 days prior to randomization, for women of childbearing potential only
- Provide informed written consent
- Willing to return to Sichuan cancer hospital for follow-up
- Willing to provide tissue and blood samples for correlative research purposes
Who cannot join
- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- Known allergic to EGFR TKI any ingredients
- Prior chemotherapy or treatment for metastatic non-small cell lung cancer
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
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- Other active malignancy<=3 years prior to randomization;
- Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
- History of bleeding diathesis or coagulopathy
- Inadequately controlled hypertension (systolic blood pressure of>150 mmHg or diastolic pressure>100 mmHg on anti-hypertensive medications)
- Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury <=28 days or core biopsy <=7 days prior to randomization
- Pregnancy or breast-feeding women
- Other situation which researchers think that doesn't fit into the group
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Icotinib Combined With Stereotactic Body Radiation Therapy (SBRT) for Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Sensitive Mutation
Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine kinase inhibitors experience limited sites of disease progression. For multiple metastases in patients with advanced NSCLC, increased local treatment may benefit to prolong patient survival. This study investigated the benefits of icotinib limited systemic disease progression and continuation of Stereotactic Body Radiation Therapy,in patients with metastatic EGFR-mutant NSCLC.
Read the detailed description
Lung cancer is the leading cause of cancer morbidity and mortality worldwide. The majority of lung cancer is nonsquamous NSCLC. EGFR tyrosine kinase inhibitors (EGFR-TKI) is a effective first-line treatment for EGFR mutations non-squamous NSCLC treatment.Icotinib is the first EGFR-TKI,and have been proved efficiently in the treatment of lung cancer, and SBRT become a main therapy for the primary lesion,Accordingly, we have come to a scientific hypothesis that icotinib combination with SBRT might be a better treatment strategy for stageIV non-squamous NSCLC patients with EGFR mutation. It can improve the PFS of stage ⅢB/Ⅳ non-squamous NSCLC patients with EGFR mutation . The primary endpoint is disease-free time to progression (PFS). The secondary study endpoint is objective response rate (ORR), disease control rate (DCR),overall survival(OS) safety and quality of life (QOL). Through this study lay the foundation for further exploration of the non-squamous NSCLC first-line treatment in patients with EGFR mutation strategy.
- Conditions
- Lung Cancer Stage IV
- Being tested
- Icotinib, SBRT
- Keywords
- EGFR mutation icotinib SBRT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Icotinib Hydric
icotinib 125 milligram three times a day
SBRTRadiation
Also called Stereotactic Body Radiation Therapy
given radiation for the primary lesion
| Study group | Role | What they receive |
|---|---|---|
| icotinib+SBRT | Experimental | icotinib 125 milligram,three times a day for 28 days oral administration,12weeks later given the SBRT treatment depended on the outcome of icotinib Receives: Drug: Icotinib; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the time to disease to progression according the RESCIT
Measured: four weeks
Secondary outcomes (1)
object responsible rate
the proportion the patients have receives the complete remission and partial remission
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start2 Jun 2017 (estimated)
- Primary completion2 Nov 2017 (estimated)
- Study completion2 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IVStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- icotinib and SBRT treat the lung cancer with egfr mutation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
- Investigators
- juan li, MD, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153358
- Sponsor's protocol ID
- EK2017001
- Status last verified
- May 2017
- First submitted
- 7 May 2017
- Last updated
- 16 May 2017
- Results posted
- 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 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib Combined With Stereotactic Body Radiation Therapy (SBRT) for Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Sensitive Mutation
- ClinicalTrials.gov ID
- NCT03153358
- Acronym / sponsor ID
- EK2017001
- Conditions
- Lung Cancer Stage IV
- Keywords
- EGFR mutation icotinib SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 2 Jun 2017 (estimated)
- Primary completion
- 2 Nov 2017 (estimated)
- Study completion
- 2 May 2019 (estimated)
- First posted
- 15 May 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.
Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine kinase inhibitors experience limited sites of disease progression. For multiple metastases in patients with advanced NSCLC, increased local treatment may benefit to prolong patient survival. This study investigated the benefits of icotinib limited systemic disease progression and continuation of Stereotactic Body Radiation Therapy,in patients with metastatic EGFR-mutant NSCLC.
Detailed description
Lung cancer is the leading cause of cancer morbidity and mortality worldwide. The majority of lung cancer is nonsquamous NSCLC. EGFR tyrosine kinase inhibitors (EGFR-TKI) is a effective first-line treatment for EGFR mutations non-squamous NSCLC treatment.Icotinib is the first EGFR-TKI,and have been proved efficiently in the treatment of lung cancer, and SBRT become a main therapy for the primary lesion,Accordingly, we have come to a scientific hypothesis that icotinib combination with SBRT might be a better treatment strategy for stageIV non-squamous NSCLC patients with EGFR mutation. It can improve the PFS of stage ⅢB/Ⅳ non-squamous NSCLC patients with EGFR mutation . The primary endpoint is disease-free time to progression (PFS). The secondary study endpoint is objective response rate (ORR), disease control rate (DCR),overall survival(OS) safety and quality of life (QOL). Through this study lay the foundation for further exploration of the non-squamous NSCLC first-line treatment in patients with EGFR mutation strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- icotinib and SBRT treat the lung cancer with egfr mutation
| Arm | Type | Receives |
|---|---|---|
| icotinib+SBRT | Experimental | Drug: Icotinib, Radiation: SBRTicotinib 125 milligram,three times a day for 28 days oral administration,12weeks later given the SBRT treatment depended on the outcome of icotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation.
- Stage disease according to the 7th Edition of the American Joint Committee on Cancer staging system
- Not received radiotherapy, chemotherapy or other biological treatment
- Measureable disease
- Life expectancy of>=12 months
Key exclusion criteria (13 listed)
- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- Known allergic to EGFR TKI any ingredients
- Prior chemotherapy or treatment for metastatic non-small cell lung cancer
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| IcotinibAlso: Icotinib Hydricicotinib 125 milligram three times a day | Drug | icotinib+SBRT |
| SBRTAlso: Stereotactic Body Radiation Therapygiven radiation for the primary lesion | Radiation | icotinib+SBRT |
Primary outcome
progression free survival
Time frame: four weeks
the time to disease to progression according the RESCIT
1 secondary outcome
object responsible rate
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- 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.
juan li, MD principal investigator
Sichuan Cancer Hospital and Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icotinib and SBRT in people with Lung Cancer Stage IV, run by Sichuan Cancer Hospital and Research Institute.
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 17 inclusion and 13 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 16 May 2017. 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 juan li, doctor (+8613880276636, dr.lijuan@gmail.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: four weeks). 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 16 May 2017.