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Non-Small Cell Lung CancerPhase 2NCT00922584

Sorafenib Treatment in Non-Small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

A Phase 2 study testing sorafenib (Nexavar) in people with Non-Small Cell Lung Cancer, run by Chinese Society of Lung Cancer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation between clinical outcomes and biochemical modulation of signal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
sorafenib (Nexavar)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
Dec 2008to Apr 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 IIIB (not amenable for radical regional therapy) or stage IV NSCLC. The pathological diagnosis must be adenocarcinoma with or without bronchioalveolar carcinoma. Sputum cytology alone is excluded.
  • Recurrent or progressive disease after prior one EGFR-TKI treatment. The patient must have stopped the EGFR-TKI treatment for at least two weeks. The response to EGFR-TKI should be partial response or complete response or stable disease (the duration of stable disease should be more than 3 months). Patients who had never received chemotherapy or received one regimen chemotherapy before EGFR-TKI are eligible.
  • Prior surgery, including palliative surgery, is permitted if performed 4 weeks before the start of study treatment and the patient is fully recovered.
  • Prior localized radiotherapy 4 weeks before the start of study is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented. Patient has recovered from CTCAE grade 3/4 toxicity of radiotherapy. Palliative radiotherapy within 4 weeks of start of study is also permitted.
  • Age > 18 years.
  • ECOG Performance Status of 0, 1,or 2. Life expectancy of at least 3 months. Measurable disease, according to the RECIST, the presence of at least one uni-dimensional measurable lesion with longest diameter > 20 mm by conventional techniques or > 10 mm by spiral CT scan.
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  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • Hemoglobin > 9.0 g/dl
  • Platelet count > 75x109/L
  • Total bilirubin ≤ 1.5 x upper limit of normal
  • ALT and AST < 2.5 x upper limit of normal without liver metastasis, ALT and AST < 5 x upper limit of normal with liver metastasis.
  • International normalized ratio (INR) ≤ 1.5 x the upper limit of normal and prothrombin time (PT) ≤ 1.5 x the upper limit of normal. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
  • Serum creatinine < 1.5 x upper limit of normal.

Who cannot join

  • Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial.
  • Mixed small cell and non-small cell lung cancer histology. Other pathological types of NSCLC than adenocarcinoma and bronchioloalveolar cell carcinoma.
  • Failure of EGFR-TKI is due to toxicity.
  • Prior with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
  • Prior exposure to sorafenib or other agents targeting the Ras/MARK pathway or VEGFR.
  • Any unresolved toxicity more than CTCAE grade 2 from previous anti-cancer therapy.
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  • Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0(Conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTC > 0.45-0.47 second); however, patients with grade 2 atrial fibrillation may be included.
  • Significant cardiovascular event: congestive heart failure > NYHA class 2; unstable angina, active CAD (myocardial infarction more than 6 months prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
  • Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication (sorafenib) or that might affect the interpretation of the results or render the subject at high risk from treatment.
  • Central nervous system (CNS) tumor or metastatic tumor.
  • Clinically significant gastrointestinal bleeding within 30 days of study entry.

Trial locations and contacts

1 site in 1 country.

China1 site

  • WuYiLong

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Phase II Study of Sorafenib (BAY 43-9006®) in Patients With Relapsed Advanced Non-Small Cell Lung Cancer(NSCLC) After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)Treatment

This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation between clinical outcomes and biochemical modulation of signal transduction pathways.

Read the detailed description

Sorafenib, an oral multi-kinase inhibitor, targets the Raf/MEK/ERK pathway at the level of Raf kinase and VEGF receptor tyrosine kinases, and has shown efficacy against NSCLC in Phase I/II trials. Because the targets of sorafenib are different from that of EGFR-TKI, it is reasonable for sorafenib to treat relapsed advanced NSCLC after failure of EGFR-TKI treatment.

Being tested
sorafenib (Nexavar)
Keywords
non-small cell lung cancer, Sorafenib, targeted therapy
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.

  • sorafenib (Nexavar)Drug

    oral sorafenib 400 mg, twice daily, until disease progression or unacceptable toxicity

Study groups in NCT00922584
Study groupRoleWhat they receive
sorafenibExperimentalPatients with stage IIIB/IV NSCLC who failed EGFR-TKI therapy will receive oral sorafenib 400 mg twice daily until disease progression or unacceptable toxicity.
Receives: Drug: sorafenib (Nexavar)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (CR+PR+SD)

    Measured: 1 year

Secondary outcomes (5)

  1. Response duration

    Measured: 2 years

  2. time-to-progression

    Measured: 2 years

  3. progression free survival

    Measured: 2 years

  4. overall survival

    Measured: 2 years

  5. safety profile

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionJan 2012
  4. Study completionApr 2012

Resources

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00922584
Sponsor's protocol ID
C-TONG0805
Status last verified
Aug 2013
First submitted
9 Jun 2009
Last updated
21 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhou Q, Zhou CC, Chen GY, Cheng Y, Huang C, Zhang L, Xu CR, Li AW, Yan HH, Su J, Zhang XC, Yang JJ, Wu YL. A multicenter phase II study of sorafenib monotherapy in clinically selected patients with advanced lung adenocarcinoma after failure of EGFR-TKI therapy (Chinese Thoracic Oncology Group, CTONG 0805). Lung Cancer. 2014 Mar;83(3):369-73. doi: 10.1016/j.lungcan.2013.12.014. Epub 2014 Jan 5.

    PubMed 24440279

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib (Nexavar) in people with Non-Small Cell Lung Cancer, run by Chinese Society of Lung Cancer 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 11 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 21 Aug 2013. 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?

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?

Disease control rate (CR+PR+SD) (time frame: 1 year). 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 NCT00922584, 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 21 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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