Non-Small Cell Lung CancerPhase 2NCT00663689
Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung Cancer
A Phase 2 study testing erlotinib in people with Non-Small Cell Lung Cancer and Brain Metastases, run by Guangdong Provincial People's Hospital.
Trial summary
This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Brain Metastases
- What is being tested?
- erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded
- Extracerebral lesions show stable disease after first line chemotherapy. Patient has recovered from CTCAE grade 3/4 toxicity. Patients who had never received EGFR-TKI or EGFR monoclonal antibody.
- Patients must be at least 18 years.
- ECOG Performance Status 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI.
Show all 13Show fewer
- Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L.
- Total bilirubin £ 1.5 x upper limit of normal (ULN)
- ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
- PT-INR/PTT < 1.2 x ULN.
- Written informed consent.
- Able to comply with study and follow-up procedures.
Who cannot join
- Mixed small cell and non-small cell lung cancer histology.
- Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
- Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
- Other concurrent anticancer therapy.
- Patients with exposure to investigational drug therapy outside of this trial.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
Show all 13Show fewer
- Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication).
- Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrhythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension.
- Brain metastases or spinal cord compression, if treated before the start of study treatment, and have any symptoms. Symptoms include signs of increased intracranial pressure ,headache,nausea and vomiting,cognitive or affective disturbances,seizures,and focal neurologic symptoms.
- History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis \& T1].
- Pregnant or breast-feeding women.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
About this study
Official title: A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.
This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral erlotinib 150mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of erlotinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastases
- Being tested
- erlotinib
- Keywords
- erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinibDrug
Also called TARVECA
erlotinib 150mg qd until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity Receives: Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
Measured: 3/2008~3/2011
Secondary outcomes (1)
To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety.
Measured: 3/2008~3/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2011 (estimated)
- Study completionJan 2012 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wu Yilong, MD, Principal investigator, Cancer center of Guangdong PPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663689
- Sponsor's protocol ID
- cslc0803
- Status last verified
- Apr 2008
- First submitted
- 17 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.
- ClinicalTrials.gov ID
- NCT00663689
- Acronym / sponsor ID
- cslc0803
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastases
- Keywords
- erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 22 Apr 2008 (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.
This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral erlotinib 150mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of erlotinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: erlotinibnon-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded
- Extracerebral lesions show stable disease after first line chemotherapy. Patient has recovered from CTCAE grade 3/4 toxicity. Patients who had never received EGFR-TKI or EGFR monoclonal antibody.
- Patients must be at least 18 years.
- ECOG Performance Status 0, 1 or 2.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (13 listed)
- Mixed small cell and non-small cell lung cancer histology.
- Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
- Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
- Other concurrent anticancer therapy.
- Patients with exposure to investigational drug therapy outside of this trial.
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: TARVECAerlotinib 150mg qd until disease progression or unacceptable toxicity. | Drug | 1 |
Primary outcome
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
Time frame: 3/2008~3/2011
1 secondary outcome
To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety.
Time frame: 3/2008~3/2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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 Yilong, MD principal investigator
Cancer center of Guangdong PPH
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib in people with Non-Small Cell Lung Cancer and Brain Metastases, run by Guangdong Provincial People's Hospital.
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 13 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 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis (time frame: 3/2008~3/2011). 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 22 Apr 2008.