Non Small Cell Lung CancerPhase 2SELECTNCT00462995
Surgery for Early Lung Cancer With Preoperative Erlotinib (Tarceva): A Clinical Phase II Trial (SELECT)
A Phase 2 study testing Erlotinib in people with Non Small Cell Lung Cancer, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
2.5 Rationale for preoperative erlotinib therapy Erlotinib is the only EFGR tyrosine kinase inhibitor to demonstrate a survival advantage and symptom improvement in a large phase III trial after failure of chemotherapy in advanced non-small cell lung cancer (Shepherd, Rodrigues Pereira et al. 2005). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- May 2006to Feb 2012
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have cytology or biopsy-proven non-small cell lung carcinoma (NSCLC);
- Preoperative clinical stage must be 1A (T1N0), 1B(T2N0), 2A (T1N1) and 2B (T2N1) by radiographic criteria;
- Patients must be deemed appropriate candidates for resection by the treating surgeon and surgical assessment team;
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan;
- Age ³ 18 years;
- ECOG performance status £ 2 (Karnofsky ³ 60%; see Appendix A);
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- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ³1,500/uL
- platelets ³100,000/uL
- total bilirubin £1.5 times institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) £2 times institutional upper limit of normal
- creatinine £1.5 times institutional upper limit of normal , or creatinine clearance³50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;
- The effects of erlotinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (abstinence, hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;
- Patients on warfarin are not excluded from the trial but are required to have their INR measured intensively during the initial stages of starting the study drug as alterations in INR have been noted. This intensive monitoring should entail measurements (3 X week for the first week then twice weekly for the remainder of the trial);
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients clinically T2N1 (2B), and/or T3N0 (2B) requiring a sleeve lobectomy, and/or chest wall resection; and tumors with higher staging;
- Patients who have received prior anticancer treatment with chemotherapy, radiotherapy or EGFR inhibitor therapy;
- Patients who have had a previous diagnosis of cancer within 5 years are excluded except adequately treated non-melanoma skin cancer, and carcinoma in situ of the cervix or breast;
- Patients may not be receiving any other investigational or anticancer agents while on study;
- History of allergic reactions to erlotinib;
- Pre-existing diarrhea ³ NCI CTC Grade 2 (4 to 6 loose stools per day) not controlled on standard therapy;
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, poorly controlled diabetes mellitus, clinically significant or untreated ophthalmologic (e.g. Sjogrens etc.) or gastrointestinal conditions (e.g. Crohn's disease, ulcerative colitis) or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study, as the effects of erlotinib on a developing fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib, breastfeeding should be discontinued if the mother is treated with this combination.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib.
- Active malignancy at any other site including combined small cell and non-small cell carcinomas or a pulmonary carcinoid tumor;
- Because drugs that induce CYP3A4 enzymes have been shown to significantly reduce plasma concentrations of erlotinib, patients with ongoing use of phenytoin, rifampicin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded;
- Incomplete healing from previous surgery;
- Use of any agent that decreases gastric pH, including proton pump inhibitors, histamine-2 receptor blockers or sodium bicarbonate. Use of calcium or magnesium based elixirs are not included;
- Concomitant use of CYP3A4 inhibitors, e.g. itraconazole, may result in increased levels of erlotinib (TARCEVA®). This increase may be clinically relevant since adverse experiences are related to dose and exposure.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Surgery for Early Lung Cancer With Preoperative Erlotinib (Tarceva): A Clinical Phase II Trial
2.5 Rationale for preoperative erlotinib therapy
Erlotinib is the only EFGR tyrosine kinase inhibitor to demonstrate a survival advantage and symptom improvement in a large phase III trial after failure of chemotherapy in advanced non-small cell lung cancer (Shepherd, Rodrigues Pereira et al. 2005). Although the potential utility of erlotinib in earlier stage NSCLC is unclear, given its activity in advanced disease and its minimal toxicity profile, there is likely a subset of patients who may benefit and potentially be cured by adjuvant erlotinib therapy. Erlotinib may also have greater antitumour activity in earlier stage disease. Therefore, we propose a phase II study to assess erlotinib pre-operatively in clinical stage 1 and 2 NSCLC, and downstream effects on signal transduction pathways and possible markers of treatment resistance and sensitivity.
The proposed study involves administering oral erlotinib for four weeks (28 days) preoperatively in early stage (1A/B, 2A/B) NSCLC. Current waiting times for surgical resection of early stage NSCLC at UHN ranges from 4 to 6 weeks (Hui, Johnston et al. 2004), thus patients would not experience significant delay in time to surgery through this trial design. This study provides the opportunity to explore the impact of erlotinib on early stage NSCLC in humans, with pharmacodynamic assessment expected in 100% of patients post-treatment, in addition to correlative imaging. This study will evaluate the feasibility of preoperative therapy with erlotinib, and may facilitate the identification of predictive markers for response to erlotinib in early stage NSCLC. This may help further define the subset of patients who would benefit from adjuvant EGFR tyrosine kinase inhibitors, and those who may require other adjuvant approaches including chemotherapy and further clinical trials.
Read the detailed description
Treatment will be administered on an outpatient basis. Patients may be identified by thoracic surgeons, respirologists and/or interventional chest radiologists for study participation upon clinical and radiographic assessment.
4.2 Diagnostic biopsy, Pretreatment Investigations
If patients have already had a core or FNA biopsy before referral, this material will be sought from the original pathologist for review and inclusion in the study with appropriate consent sought. If a patient does not have a biopsy upon presentation to the thoracic surgeon, and consents to inclusion in the trial, a percutaneous biopsy will be mandated as part of entry into the study. The order of test will be up to the treating thoracic surgeon. As part of this procedure a large localizing needle is inserted into the tumour. In collaboration with pathology, a fine needle is passed through the outer needle and an immediate diagnosis will be made at the time of fine needle aspiration biopsy. After a pathologic diagnosis of cancer is confirmed, additional biopsies to obtain material for correlative studies will be performed through the standard localizing needle, assuming no complications or technical difficulties have arisen. These studies will be done in collaboration with thoracic interventional radiologists from Diagnostic Imaging, who perform the lung fine needle aspirates and biopsies.
All patients will undergo pre-study assessments for symptoms, performance status, radiographic assessment and blood tests (complete blood count, electrolytes, liver and renal function tests). Blood samples before treatment and post treatment with erlotinib will be banked for future serum proteomic analysis. Assessment of response will occur after the 4-week treatment period. Toxicity will be assessed continuously, with patient assessment weekly on treatment, repeat blood tests at 2 weeks and imaging of measurable disease at 4 weeks. All subjects will be invited to have their initial diagnostic biopsy and subsequent surgical tumor specimen examined as part of the laboratory correlate component of the study. Patients will be considered evaluable for pharmacodynamic assessment if they complete at least 21 of the planned 28 days of therapy.
Patients will have PET-CT scan study done pre- and post-treatment (see section 7). If the enrolment PET-CT imaging reveals mediastinal disease (IIIA or IIIB) or extensive disease and this is pathologically confirmed the patient will not be enrolled in the study.
Once the diagnosis is established and assessment completed, oral erlotinib will be administered at a dose of 150 mg (1 pill) daily for 28 days prior to the planned mediastinoscopy and/or surgery. Tablets should be taken preferably in the morning with up to 200 mL of water at least 1 hour before or 2 hours after meals. If the patient forgets to take a dose, they should take the last missed dose as soon as they remember, as long as it is at least 12 hours before the next dose is due. If patient vomits after taking the dose, the dose may be retaken if the tablet is seen in the emesis. The last dose of erlotinib will be administered early in the morning of the mediastinoscopy or surgery.
If the mediastinoscopy reveals the presence of Stage III disease, the patient's mediastinoscopy samples may still be analyzed as part of the correlative study. Patients will be followed for 90 days or as long as required after the last dose of erlotinib to ensure resolution of any erlotinib-related toxicities. However these patients will be offered standard therapy for stage III disease off study protocol, for example a combination of chemotherapy, radiation with or without surgical resection. If these patients do proceed to thoracotomy post-chemotherapy and/or radiotherapy, their resection specimen will not be eligible for this correlative protocol.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Erlotinib
- Keywords
- Non Small Cell Lung Cancer, Lung Cancer, Erlotinib, Neoadjuvant Treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
150mg once a day for 28 days
ErlotinibDrug
28 days of Erlotinib before surgery in patients with stage I-IIb NSCLC
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Active comparator | Erlotinib 150mg once a day p.o Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in tumor cell proliferation measured by a 75% reduction of Ki67 Immunohistochemistry (ICH) expression comparing pre and postoperative lung cancer
Measured: Before surgery and after surgery
Secondary outcomes (1)
response rate, stable disease rate evaluated by RECIST criteria, median overall and disease-free survival time, 1-year overall and disease-free survival rate, toxicity and time to disease progression
Measured: Baseline, 2weeks, 4weeks and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMay 2006
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Natasha Leighl, MD FRCPC, Principal investigator, University Health Network, TorontoThomas Waddell, MD FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462995
- Sponsor's protocol ID
- UHN REB#: 06-0052-C
- Acronym
- SELECT
- Status last verified
- Feb 2018
- First submitted
- 17 Apr 2007
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shepherd, F. A., J. Pereira, et al. (2004).
Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
PubMed 11668491Pavelic K, Banjac Z, Pavelic J, Spaventi S. Evidence for a role of EGF receptor in the progression of human lung carcinoma. Anticancer Res. 1993 Jul-Aug;13(4):1133-7.
PubMed 8394672Soulieres D, Senzer NN, Vokes EE, Hidalgo M, Agarwala SS, Siu LL. Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol. 2004 Jan 1;22(1):77-85. doi: 10.1200/JCO.2004.06.075.
PubMed 14701768Shepherd, F. A., J. Rodrigues Pereira, et al. (2005).
Weber WA, Petersen V, Schmidt B, Tyndale-Hines L, Link T, Peschel C, Schwaiger M. Positron emission tomography in non-small-cell lung cancer: prediction of response to chemotherapy by quantitative assessment of glucose use. J Clin Oncol. 2003 Jul 15;21(14):2651-7. doi: 10.1200/JCO.2003.12.004.
PubMed 12860940Scagliotti GV, Selvaggi G, Novello S, Hirsch FR. The biology of epidermal growth factor receptor in lung cancer. Clin Cancer Res. 2004 Jun 15;10(12 Pt 2):4227s-4232s. doi: 10.1158/1078-0432.CCR-040007.
PubMed 15217963
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Early Lung Cancer With Preoperative Erlotinib (Tarceva): A Clinical Phase II Trial
- ClinicalTrials.gov ID
- NCT00462995
- Acronym / sponsor ID
- SELECT / UHN REB#: 06-0052-C
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Lung Cancer, Erlotinib, Neoadjuvant Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Apr 2007 (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.
2.5 Rationale for preoperative erlotinib therapy
Erlotinib is the only EFGR tyrosine kinase inhibitor to demonstrate a survival advantage and symptom improvement in a large phase III trial after failure of chemotherapy in advanced non-small cell lung cancer (Shepherd, Rodrigues Pereira et al. 2005). Although the potential utility of erlotinib in earlier stage NSCLC is unclear, given its activity in advanced disease and its minimal toxicity profile, there is likely a subset of patients who may benefit and potentially be cured by adjuvant erlotinib therapy. Erlotinib may also have greater antitumour activity in earlier stage disease. Therefore, we propose a phase II study to assess erlotinib pre-operatively in clinical stage 1 and 2 NSCLC, and downstream effects on signal transduction pathways and possible markers of treatment resistance and sensitivity.
The proposed study involves administering oral erlotinib for four weeks (28 days) preoperatively in early stage (1A/B, 2A/B) NSCLC. Current waiting times for surgical resection of early stage NSCLC at UHN ranges from 4 to 6 weeks (Hui, Johnston et al. 2004), thus patients would not experience significant delay in time to surgery through this trial design. This study provides the opportunity to explore the impact of erlotinib on early stage NSCLC in humans, with pharmacodynamic assessment expected in 100% of patients post-treatment, in addition to correlative imaging. This study will evaluate the feasibility of preoperative therapy with erlotinib, and may facilitate the identification of predictive markers for response to erlotinib in early stage NSCLC. This may help further define the subset of patients who would benefit from adjuvant EGFR tyrosine kinase inhibitors, and those who may require other adjuvant approaches including chemotherapy and further clinical trials.
Detailed description
Treatment will be administered on an outpatient basis. Patients may be identified by thoracic surgeons, respirologists and/or interventional chest radiologists for study participation upon clinical and radiographic assessment.
4.2 Diagnostic biopsy, Pretreatment Investigations
If patients have already had a core or FNA biopsy before referral, this material will be sought from the original pathologist for review and inclusion in the study with appropriate consent sought. If a patient does not have a biopsy upon presentation to the thoracic surgeon, and consents to inclusion in the trial, a percutaneous biopsy will be mandated as part of entry into the study. The order of test will be up to the treating thoracic surgeon. As part of this procedure a large localizing needle is inserted into the tumour. In collaboration with pathology, a fine needle is passed through the outer needle and an immediate diagnosis will be made at the time of fine needle aspiration biopsy. After a pathologic diagnosis of cancer is confirmed, additional biopsies to obtain material for correlative studies will be performed through the standard localizing needle, assuming no complications or technical difficulties have arisen. These studies will be done in collaboration with thoracic interventional radiologists from Diagnostic Imaging, who perform the lung fine needle aspirates and biopsies.
All patients will undergo pre-study assessments for symptoms, performance status, radiographic assessment and blood tests (complete blood count, electrolytes, liver and renal function tests). Blood samples before treatment and post treatment with erlotinib will be banked for future serum proteomic analysis. Assessment of response will occur after the 4-week treatment period. Toxicity will be assessed continuously, with patient assessment weekly on treatment, repeat blood tests at 2 weeks and imaging of measurable disease at 4 weeks. All subjects will be invited to have their initial diagnostic biopsy and subsequent surgical tumor specimen examined as part of the laboratory correlate component of the study. Patients will be considered evaluable for pharmacodynamic assessment if they complete at least 21 of the planned 28 days of therapy.
Patients will have PET-CT scan study done pre- and post-treatment (see section 7). If the enrolment PET-CT imaging reveals mediastinal disease (IIIA or IIIB) or extensive disease and this is pathologically confirmed the patient will not be enrolled in the study.
Once the diagnosis is established and assessment completed, oral erlotinib will be administered at a dose of 150 mg (1 pill) daily for 28 days prior to the planned mediastinoscopy and/or surgery. Tablets should be taken preferably in the morning with up to 200 mL of water at least 1 hour before or 2 hours after meals. If the patient forgets to take a dose, they should take the last missed dose as soon as they remember, as long as it is at least 12 hours before the next dose is due. If patient vomits after taking the dose, the dose may be retaken if the tablet is seen in the emesis. The last dose of erlotinib will be administered early in the morning of the mediastinoscopy or surgery.
If the mediastinoscopy reveals the presence of Stage III disease, the patient's mediastinoscopy samples may still be analyzed as part of the correlative study. Patients will be followed for 90 days or as long as required after the last dose of erlotinib to ensure resolution of any erlotinib-related toxicities. However these patients will be offered standard therapy for stage III disease off study protocol, for example a combination of chemotherapy, radiation with or without surgical resection. If these patients do proceed to thoracotomy post-chemotherapy and/or radiotherapy, their resection specimen will not be eligible for this correlative protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Active comparator | Drug: ErlotinibErlotinib 150mg once a day p.o |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have cytology or biopsy-proven non-small cell lung carcinoma (NSCLC);
- Preoperative clinical stage must be 1A (T1N0), 1B(T2N0), 2A (T1N1) and 2B (T2N1) by radiographic criteria;
- Patients must be deemed appropriate candidates for resection by the treating surgeon and surgical assessment team;
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan;
- Age ³ 18 years;
Key exclusion criteria (14 listed)
- Patients clinically T2N1 (2B), and/or T3N0 (2B) requiring a sleeve lobectomy, and/or chest wall resection; and tumors with higher staging;
- Patients who have received prior anticancer treatment with chemotherapy, radiotherapy or EGFR inhibitor therapy;
- Patients who have had a previous diagnosis of cancer within 5 years are excluded except adequately treated non-melanoma skin cancer, and carcinoma in situ of the cervix or breast;
- Patients may not be receiving any other investigational or anticancer agents while on study;
- History of allergic reactions to erlotinib;
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: Tarceva150mg once a day for 28 days | Drug | Erlotinib |
| Erlotinib28 days of Erlotinib before surgery in patients with stage I-IIb NSCLC | Drug | Erlotinib |
Primary outcome
changes in tumor cell proliferation measured by a 75% reduction of Ki67 Immunohistochemistry (ICH) expression comparing pre and postoperative lung cancer
Time frame: Before surgery and after surgery
1 secondary outcome
response rate, stable disease rate evaluated by RECIST criteria, median overall and disease-free survival time, 1-year overall and disease-free survival rate, toxicity and time to disease progression
Time frame: Baseline, 2weeks, 4weeks and 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- BackgroundShepherd, F. A., J. Pereira, et al. (2004).
- Background: PubMed 11668491Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
- Background: PubMed 8394672Pavelic K, Banjac Z, Pavelic J, Spaventi S. Evidence for a role of EGF receptor in the progression of human lung carcinoma. Anticancer Res. 1993 Jul-Aug;13(4):1133-7.
- Background: PubMed 14701768Soulieres D, Senzer NN, Vokes EE, Hidalgo M, Agarwala SS, Siu LL. Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol. 2004 Jan 1;22(1):77-85. doi: 10.1200/JCO.2004.06.075.
- BackgroundShepherd, F. A., J. Rodrigues Pereira, et al. (2005).
- Background: PubMed 12860940Weber WA, Petersen V, Schmidt B, Tyndale-Hines L, Link T, Peschel C, Schwaiger M. Positron emission tomography in non-small-cell lung cancer: prediction of response to chemotherapy by quantitative assessment of glucose use. J Clin Oncol. 2003 Jul 15;21(14):2651-7. doi: 10.1200/JCO.2003.12.004.
- Background: PubMed 15217963Scagliotti GV, Selvaggi G, Novello S, Hirsch FR. The biology of epidermal growth factor receptor in lung cancer. Clin Cancer Res. 2004 Jun 15;10(12 Pt 2):4227s-4232s. doi: 10.1158/1078-0432.CCR-040007.
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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.
Natasha Leighl, MD FRCPC principal investigator
University Health Network, Toronto
Thomas Waddell, MD FRCSC principal investigator
University Health Network, Toronto
2 sites 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 in people with Non Small Cell Lung Cancer, run by University Health Network, Toronto at 2 sites in Canada.
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 15 inclusion and 14 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in tumor cell proliferation measured by a 75% reduction of Ki67 Immunohistochemistry (ICH) expression comparing pre and postoperative lung cancer (time frame: Before surgery and after surgery). 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 NCT00462995, which also lists 7 linked publications.
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 23 Feb 2018.