Non-small Cell Lung CancerPhase 2/3TRENDNCT03074864
Targeted Treatment With Intercalated Radiotherapy in EGFR-mutant IIIA/IIIB NSCLC
A Phase 2/3 study testing Erlotinib Hydrochloride in people with Non-small Cell Lung Cancer and Epidermal Growth Factor Receptor, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor
- What is being tested?
- Erlotinib Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2017to 30 Jun 2020
- Phase
- Phase 2/3
- 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
- Males or females aged ≥18 years.
- ECOG performance status 0-2.
- Pathologically diagnosed of non-small cell lung cancer, and staged as unresectable IIIA/IIIB according the TNM staging system (2009).
- EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma.
- Measurable disease must be characterized according to RECIST 1.1 criteria.
- Life expectancy ≥12 weeks.
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- Adequate pulmonary function: FEV1.0 >50% of the normal predicted value, or DLCO >40% of the normal predicted value.
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3.0 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function: serum creatinine ≤ 1. 5 x ULN, and creatinine clearance ≥ 45 ml/min.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥1.0 x 109/L, and Platelet count ≥75 x 109/L, and Hemoglobin ≥8 g/dL.
- Female subjects should not be pregnant or breast-feeding.
- Written informed consent provided.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Who cannot join
- Histologically mixed with small-cell lung cancer.
- Mutations in EGFR exon 20 are detected.
- Exposure to prior chest irradiation before the enrollment.
- Patients with prior chemotherapy or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Existence of interstitial lung disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer
The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.
Read the detailed description
Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.
- Being tested
- Erlotinib Hydrochloride
- Keywords
- Activating mutations,lung cancer,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.
Erlotinib HydrochlorideDrug
Also called Cp-358,774, OSI-774, Tarceva
Subjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| EGFR-mutant IIIA/IIIB NSCLC | Experimental | Erlotinib Hydrochloride 150mg daily intercalated with radiotherapy Receives: Drug: Erlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
assessed by the RECIST 1.1 criteria
Measured: Tumor response will be evaluated through study completion, an average of 6 weeks.
Secondary outcomes (4)
1 year survival rate
To evaluate the 1 year survival rate of the new strategy.
Measured: Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.
3 year survival rate
To evaluate the 3 year survival rate of the new strategy.
Measured: Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.
Progression free survival（PFS）
The product limit estimator developed by Kaplan and Meier will be used.
Measured: Occurrence of local or regional progression, distant metastases, or death from any cause from the time of treatment to the occurrence of one of the failure events, whichever occurs first, assessed up to 10 years.
Overall survival
The product limit estimator developed by Kaplan and Meier will be used. Their 95% confidence intervals will be estimated.
Measured: Time from treatment to death from any cause, assessed up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start27 Feb 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2020 (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.
- More trials run by Guangdong Provincial People's HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- EGFR-TKI intercalted with radiotherapy
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huajun CHEN, Guangdong Provincial People's Hospital
- Investigators
- Hua-Jun CHEN, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074864
- Sponsor's protocol ID
- TREND
- Acronym
- TREND
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03074864
- Acronym / sponsor ID
- TREND / TREND
- Keywords
- Activating mutations,lung cancer,radiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Mar 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.
The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.
Detailed description
Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- EGFR-TKI intercalted with radiotherapy
| Arm | Type | Receives |
|---|---|---|
| EGFR-mutant IIIA/IIIB NSCLC | Experimental | Drug: Erlotinib HydrochlorideErlotinib Hydrochloride 150mg daily intercalated with radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or females aged ≥18 years.
- ECOG performance status 0-2.
- Pathologically diagnosed of non-small cell lung cancer, and staged as unresectable IIIA/IIIB according the TNM staging system (2009).
- EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma.
- Measurable disease must be characterized according to RECIST 1.1 criteria.
Key exclusion criteria (7 listed)
- Histologically mixed with small-cell lung cancer.
- Mutations in EGFR exon 20 are detected.
- Exposure to prior chest irradiation before the enrollment.
- Patients with prior chemotherapy or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
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 HydrochlorideAlso: Cp-358,774, OSI-774, TarcevaSubjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period. | Drug | EGFR-mutant IIIA/IIIB NSCLC |
Primary outcome
Objective response rate
Time frame: Tumor response will be evaluated through study completion, an average of 6 weeks.
assessed by the RECIST 1.1 criteria
4 secondary outcomes
1 year survival rate
Time frame: Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.
3 year survival rate
Time frame: Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.
Progression free survival（PFS）
Time frame: Occurrence of local or regional progression, distant metastases, or death from any cause from the time of treatment to the occurrence of one of the failure events, whichever occurs first, assessed up to 10 years.
Overall survival
Time frame: Time from treatment to death from any cause, assessed up to 10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- 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.
Hua-Jun CHEN, MD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Erlotinib Hydrochloride in people with Non-small Cell Lung Cancer and Epidermal Growth Factor Receptor, run by Guangdong Provincial People's 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 13 inclusion and 7 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 9 Mar 2017. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Objective response rate (time frame: Tumor response will be evaluated through study completion, an average of 6 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 9 Mar 2017.