Lung CancerPhase 2NCT01565538
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
A Phase 2 study testing Erlotinib and Pemetrexed in people with Lung Cancer, run by Si-Yu Wang at 1 site in China.
Trial summary
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Erlotinib and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed Lung adenocarcinoma
- Wld-type EGFR
- Stage IIIB/IV
- Failure to prior chemotherapy
- Life expectancy of more than 3 months
- Tissue sample desired for genomic study
Show all 12Show fewer
- Age ≥ 18 years
- Performance status (WHO) < 3
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Informed consent
Who cannot join
- Have previously received pemetrexed or TKIs
- Other concurrent uncontrolled illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.
Read the detailed description
Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.
- Conditions
- Lung Cancer
- Being tested
- Erlotinib, Pemetrexed
- Keywords
- Cancer, Non-small-cell lung cancer, Adenocarcinoma, EGFR gene mutation, Chemotherapy, Pemetrexed, Erlotinib
- Medical subject headings
- Lung Neoplasms, Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
150 mg Given orally
PemetrexedDrug
Also called ALIMTA
500mg/m2 Given IV
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Erlotinib at the dose of 150 mg orally once a day continually until progression. Receives: Drug: Erlotinib |
| Pemetrexed | Experimental | Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression. Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.
Secondary outcomes (2)
Best Tumor Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.
Overall Survival
Measured: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startDec 2008
- Primary completionMay 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Si-Yu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Si-Yu Wang, Doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565538
- Sponsor's protocol ID
- wsy001
- Status last verified
- Sep 2014
- First submitted
- 22 Mar 2012
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Li N, Ou W, Yang H, Liu QW, Zhang SL, Wang BX, Wang SY. A randomized phase 2 trial of erlotinib versus pemetrexed as second-line therapy in the treatment of patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma. Cancer. 2014 May 1;120(9):1379-86. doi: 10.1002/cncr.28591. Epub 2014 Jan 30.
PubMed 24481719
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01565538
- Acronym / sponsor ID
- wsy001
- Conditions
- Lung Cancer
- Keywords
- Cancer, Non-small-cell lung cancer, Adenocarcinoma, EGFR gene mutation, Chemotherapy, Pemetrexed, Erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Si-Yu WangUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.
Detailed description
Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibErlotinib at the dose of 150 mg orally once a day continually until progression. |
| Pemetrexed | Experimental | Drug: PemetrexedPemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed Lung adenocarcinoma
- Wld-type EGFR
- Stage IIIB/IV
- Failure to prior chemotherapy
- Life expectancy of more than 3 months
Key exclusion criteria (2 listed)
- Have previously received pemetrexed or TKIs
- Other concurrent uncontrolled illness
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 |
|---|---|---|
| ErlotinibAlso: Tarceva150 mg Given orally | Drug | Erlotinib |
| PemetrexedAlso: ALIMTA500mg/m2 Given IV | Drug | Pemetrexed |
Primary outcome
Progression-Free Survival
Time frame: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
2 secondary outcomes
Best Tumor Response
Time frame: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24481719Li N, Ou W, Yang H, Liu QW, Zhang SL, Wang BX, Wang SY. A randomized phase 2 trial of erlotinib versus pemetrexed as second-line therapy in the treatment of patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma. Cancer. 2014 May 1;120(9):1379-86. doi: 10.1002/cncr.28591. Epub 2014 Jan 30.
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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.
Si-Yu Wang, Doctor principal investigator
Sun Yat-Sen University Cancer Center
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 and Pemetrexed in people with Lung Cancer, run by Si-Yu Wang 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 12 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2014. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-Free Survival (time frame: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565538, which also lists 1 linked publication.
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 15 Sep 2014.