Non-small Cell Lung CancerPhase 2NCT02738983
RT Plus EGFR-TKI for Wild-type NSCLC
A Phase 2 study testing Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) and Radiotherapy in people with Non-small Cell Lung Cancer and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), run by Hangzhou Cancer Hospital at 1 site in China.
Trial summary
Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
- What is being tested?
- Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NSCLC confirmed by histopathology or cytology;
- Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
- Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Expectancy life >= 3 months;
Who cannot join
- Had systemic anit-NSCLC treatments;
- Had be treated by HER-targeting agents;
- Had local radiotherapy for NSCLC;
- Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
- Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
- Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
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- Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
- Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
- Pregnancy or breast-feeding women;
- Ingredients mixed with small cell lung cancer patients;
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310000
Zhishuang Zheng, zhengzs19841130@163.com
About this study
Official title: Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer
Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.
- Conditions
- Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
- Being tested
- Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®), Radiotherapy
- Keywords
- Non-small cell lung cancer, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), Radiotherapy, wild type
- 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.
Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)Drug
Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).
RadiotherapyRadiation
Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| Bioradiotherapy | Experimental | Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy). Receives: Drug: Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®); Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: week 3-4
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0).
Measured: year 0- year 2
Progression-free survival
Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Measured: year 0- year 2
Overall survival
Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Measured: year 0- year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhishuang Zhen, Hangzhou Cancer Hospital
- Investigators
- Shixiu Wu, MD, Study chair, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738983
- Sponsor's protocol ID
- HangzhouCH04
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02738983
- Acronym / sponsor ID
- HangzhouCH04
- Conditions
- Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
- Keywords
- Non-small cell lung cancer, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), Radiotherapy, wild type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hangzhou Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Apr 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.
Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioradiotherapy | Experimental | Drug: Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®), Radiation: RadiotherapyErlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NSCLC confirmed by histopathology or cytology;
- Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
- Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Expectancy life >= 3 months;
Key exclusion criteria (11 listed)
- Had systemic anit-NSCLC treatments;
- Had be treated by HER-targeting agents;
- Had local radiotherapy for NSCLC;
- Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
- Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
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 |
|---|---|---|
| Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day). | Drug | Bioradiotherapy |
| RadiotherapyConcurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week. | Radiation | Bioradiotherapy |
Primary outcome
Response rate
Time frame: week 3-4
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
Time frame: year 0- year 2
Progression-free survival
Time frame: year 0- year 2
Overall survival
Time frame: year 0- year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Shixiu Wu, MD study chair
Hangzhou Cancer Hospital
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 Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) and Radiotherapy in people with Non-small Cell Lung Cancer and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), run by Hangzhou Cancer Hospital 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 5 inclusion and 11 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 14 Apr 2016. 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.
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 Zhishuang Zheng, Dr (+8657186826086, zhengzs19841130@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: week 3-4). 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 14 Apr 2016.