Non-Small Cell Lung CancerNCT00903292
Tailored Second Line Treatment by Epidermal Growth Factor Receptor (EGFR) Mutation in Patients With Advanced Lung Adenocarcinoma
A study testing erlotinib (Tarceva) and pemetrexed (Alimta) in people with Non-Small Cell Lung Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Currently the investigators have two different classes of second-line treatment options in recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- erlotinib (Tarceva) and pemetrexed (Alimta)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Dec 2010
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of adenocarcinoma of NSCLC.
- Locally advanced or metastatic disease (stage IIIB or IV), defined by the American Joint Committee on Cancer Staging Criteria for NSCLC (Fleming et al. 1997; Mountain 1997)
- Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- NOTE: First-line therapy with a tyrosine kinase inhibitor alone or regimens including pemetrexed, docetaxel, cetuximab, and trastuzumab is not allowed for enrollment in this study.
- Prior chemotherapy for earlier stage disease is allowed, but only a single regimen is allowed for prior palliative therapy of locally advanced or metastatic disease.
- Prior chemotherapy must be completed at least 2 weeks prior to study enrollment and the patient must have recovered from the acute toxic effects of the treatment.
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- Disease status must be that of measurable disease as defined by RECIST criteria (Therasse et al. 2000).
- Performance status of 0 to 2 on the ECOG Scale (See Protocol Attachment 2.).
- Estimated life expectancy of at least 8 weeks.
- Adequate organ function including the following:
- Bone marrow: absolute neutrophil count (ANC) 1.5* 109/L, platelets 100*109/L, hemoglobin 9 g/dL.
- Hepatic: bilirubin 1.5ULN, AST and ALT 2.5 ULN (AST, ALT 5 ULN is acceptable if liver has tumor involvement).
- Renal: serum creatine 1.5 ULN; Calculated creatinine clearance 45 mL/min (using the standard Cockcroft-Gault formula; Cockcroft and Gault 1976).
- For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating.
- For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after the treatment period.
- Men or women of at least 20 years of age, and signed informed consent from the patient.
Who cannot join
- Subject has untreated brain or meningeal metastases.
- CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease).
- Subjects with treated brain metastases that are radiographically or clinically stable for at least 2 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion are eligible providing that they are asymptomatic.
- Have previously completed or withdrawn from this study, or received pemetrexed, thymidylate synthetase or dihydrofolate reductase previously outside this study.
- Concurrent administration of any other tumor therapy.
- Active infection (at the discretion of the investigator).
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- History of significant neurological or mental disorder, including seizures or dementia.
- Second primary malignancy that is clinically detectable within 5 years of consideration for study enrollment.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval (e.g., warfarin or Coumadin) for any indication at the time of study entry.
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
- If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g., naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
- Inability or unwillingness to take erlotinib, folic acid, vitamin B12 supplementation, or dexamethasone.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Hui-Shu Yang, Bachelor, +886-6-2353535 ext. 4289, huishuyang@gmail.com
About this study
Official title: Tailored Second Line Treatment by EGFR Mutation in Patients With Advanced Lung Adenocarcinoma
Currently the investigators have two different classes of second-line treatment options in recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction in overall survival and progression free survival that indicated better efficacy for non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.
Read the detailed description
On the other hand, EGFR TKI (gefitinib or erlotinib) both produced somewhat similar higher response rate (around 25%) in general Taiwan adenocarcinoma NSCLC patients, while the median overall survival time didn't longer than chemotherapy treated patients. A recent prospective study of gefitinib in chemonaive adenocarcinoma NSCLC patients showed that the objective response rate was lower to be only 1.1% among EGFR mutation negative patients.
Since typical EGFR gene mutations (i.e., the deletion of typically five amino acids at codons 746-750 (ELREA) in exon 19 and a leucine-to-arginine mutation at codon 858 (L858R)) are a good predictor for tumor response to tyrosine kinase inhibitor, this present study is to tailor the patient's treatment according to his/her EGFR gene mutation status. Receptor tyrosine kinase inhibitor (erlotinib in this study) will be the suggested second-line drug of recommendation for typical EGFR gene mutation patients, and chemotherapy (pemetrexed in this study) will be the suggested second-line drug of recommendation for EGFR wild type patients.
The aim of this study is to increase the overall tumor response rate to 40% from current treatment outcome (around 25%) by this tailored second line treatment. The further interests of this study include prospectively evaluate the predictivity of EGFR gene mutation to tumor response.
The primary objective of this study is to determine the overall tumor response rate of tailored second line treatment determined by typical EGFR gene mutation in patients with advanced lung adenocarcinoma.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- erlotinib (Tarceva), pemetrexed (Alimta)
- Keywords
- EGFR, NSCLC, EGFR mutation rate
- 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 (Tarceva)Drug
chemotherapy with erlotinib
pemetrexed (Alimta)Drug
Chemotherapy with pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| A, erlotinib | Active comparator | If EGFR mutation found then assigned to thyrosine kinase inhibitor (erlotinib) Receives: Drug: erlotinib (Tarceva) |
| B, pemetrexed | Active comparator | If EGFR wild type found then assigned to chemotherapy (pemetrexed) Receives: Drug: pemetrexed (Alimta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be the overall best response rate, including a 95% confidence interval (Leemis and Trivedi 1996).
Measured: 02/2009 - 04/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010 (estimated)
- Study completionDec 2010 (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 National Cheng-Kung University 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 N/A
- Primary purpose
- Screening
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wu-Chou Su, PhD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903292
- Sponsor's protocol ID
- HR98004
- Status last verified
- May 2009
- First submitted
- 15 May 2009
- Last updated
- 18 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Second Line Treatment by EGFR Mutation in Patients With Advanced Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00903292
- Acronym / sponsor ID
- HR98004
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR, NSCLC, EGFR mutation rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 May 2009 (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.
Currently the investigators have two different classes of second-line treatment options in recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction in overall survival and progression free survival that indicated better efficacy for non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.
Detailed description
On the other hand, EGFR TKI (gefitinib or erlotinib) both produced somewhat similar higher response rate (around 25%) in general Taiwan adenocarcinoma NSCLC patients, while the median overall survival time didn't longer than chemotherapy treated patients. A recent prospective study of gefitinib in chemonaive adenocarcinoma NSCLC patients showed that the objective response rate was lower to be only 1.1% among EGFR mutation negative patients.
Since typical EGFR gene mutations (i.e., the deletion of typically five amino acids at codons 746-750 (ELREA) in exon 19 and a leucine-to-arginine mutation at codon 858 (L858R)) are a good predictor for tumor response to tyrosine kinase inhibitor, this present study is to tailor the patient's treatment according to his/her EGFR gene mutation status. Receptor tyrosine kinase inhibitor (erlotinib in this study) will be the suggested second-line drug of recommendation for typical EGFR gene mutation patients, and chemotherapy (pemetrexed in this study) will be the suggested second-line drug of recommendation for EGFR wild type patients.
The aim of this study is to increase the overall tumor response rate to 40% from current treatment outcome (around 25%) by this tailored second line treatment. The further interests of this study include prospectively evaluate the predictivity of EGFR gene mutation to tumor response.
The primary objective of this study is to determine the overall tumor response rate of tailored second line treatment determined by typical EGFR gene mutation in patients with advanced lung adenocarcinoma.
Study design
- Primary purpose
- Screening
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, erlotinib | Active comparator | Drug: erlotinib (Tarceva)If EGFR mutation found then assigned to thyrosine kinase inhibitor (erlotinib) |
| B, pemetrexed | Active comparator | Drug: pemetrexed (Alimta)If EGFR wild type found then assigned to chemotherapy (pemetrexed) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologic diagnosis of adenocarcinoma of NSCLC.
- Locally advanced or metastatic disease (stage IIIB or IV), defined by the American Joint Committee on Cancer Staging Criteria for NSCLC (Fleming et al. 1997; Mountain 1997)
- Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- Prior chemotherapy must be completed at least 2 weeks prior to study enrollment and the patient must have recovered from the acute toxic effects of the treatment.
- Disease status must be that of measurable disease as defined by RECIST criteria (Therasse et al. 2000).
Key exclusion criteria (12 listed)
- Subject has untreated brain or meningeal metastases.
- Have previously completed or withdrawn from this study, or received pemetrexed, thymidylate synthetase or dihydrofolate reductase previously outside this study.
- Concurrent administration of any other tumor therapy.
- Active infection (at the discretion of the investigator).
- History of significant neurological or mental disorder, including seizures or dementia.
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 (Tarceva)chemotherapy with erlotinib | Drug | A, erlotinib |
| pemetrexed (Alimta)Chemotherapy with pemetrexed | Drug | B, pemetrexed |
Primary outcome
The primary analysis will be the overall best response rate, including a 95% confidence interval (Leemis and Trivedi 1996).
Time frame: 02/2009 - 04/2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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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.
Wu-Chou Su, PhD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erlotinib (Tarceva) and pemetrexed (Alimta) in people with Non-Small Cell Lung Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 12 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 18 May 2009. 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 Taiwan. 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.
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 Wu-Chou Su, PHD (886-6-2353535 ext. 4289, sunnysu@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary analysis will be the overall best response rate, including a 95% confidence interval (Leemis and Trivedi 1996). (time frame: 02/2009 - 04/2010). 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 May 2009; AzTrials last refreshed its copy on 6 Nov 2026.