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Carcinoma, Non-Small-Cell LungPhase 2SIRNNCT00532025

Sorafenib in Resected Non-small Cell Lung Carcinoma

A Phase 2 study testing Sorafenib in people with Carcinoma, Non-Small-Cell Lung, run by Johannes Gutenberg University Mainz at 6 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment following surgery for NSCLC. The primary hypothesis is to increase the progression-free survival (PFS) of the experimental group in comparison to a historical control group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
6 sitesGermany
Study dates
Sep 2007to Sep 2008
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

  • Patients with histologically confirmed diagnosis of NSCLC pathological stages I, II or III A
  • Patients must have completely resected disease and may not be treated with prior chemotherapy. Patients must have fully recovered from surgery prior to initiation of study treatment.
  • Adjuvant radiotherapy for stage III A disease is permitted given that the patient has recovered from all radiation-induced toxicities. In those patients, a complete restaging will be performed prior to enrolment into the trial.
  • Patients with completely resected NSCLC stage II or III A, who for medical reasons are not eligible for adjuvant chemotherapy consisting of a standard regimen of 4 cycles cisplatin/vinorelbine
  • Patients with completely resected NSCLC stage II or III A, who are not willing to undergo adjuvant chemotherapy with 4 cycles of cisplatin/ vinorelbine, are also eligible.
  • Age ≥ 18 years
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  • ECOG performance status ≤ 2
  • Normal organ and marrow function defined as:
  • Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9 g/dL INR < 1.5 ULN and PTT within normal limits Hepatic: total bilirubin < 1.5 x ULN, AST or ALT < 2.5 x ULN Renal: creatinine < 1.5 x ULN
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate birth contraception prior to study entry and for the duration of study participation. Women and men should use adequate birth control for at least 3 months after the last administration of Sorafenib.
  • Written informed consent

Who cannot join

  • Any other histology (e.g. SCLC, carcinoid tumors) or disease stages other than I to III A
  • Patients who are eligible and willing to undergo a standard adjuvant chemotherapy regimen (4 cycles of cisplatin/vinorelbine)
  • Any prior systemic anticancer therapy including chemotherapy, targeted agents, experimental therapy or biological therapy for NSCLC
  • Cardiac disease: congestive heart failure > class II NYHA, patients must not have unstable angina pectoris or new onset of angina pectoris or myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal therapy
  • Known brain metastasis. Patients with symptoms should undergo CT scan/MRI of the brain to exclude brain metastasis
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  • Active clinically serious infections > NCI-CTCAE Grade 2
  • Thrombotic or embolic events including transient ischemic attacks within the past 6 months
  • Hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks before first dose of study drug
  • Serious non-healing wound, ulcer or bone fracture
  • Evidence or history of bleeding diathesis or coagulopathy
  • Therapeutic anticoagulation with Vitamin K antagonists such as warfarin, phenprocoumon, or with heparins or heparinoids. Low dose warfarin/phenprocoumon is permitted if INR is < 1.5. Low dose aspirin (300 mg/d) is permitted.
  • Use of St John's Wort or rifampicin
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks before first dose of study drug
  • Known or suspected allergy to Sorafenib or any agent given in the course of this trial
  • Previous cancer that is distinct in primary site or histology from NSCLC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated ≥ 3 years prior to study entry.
  • Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • SIRN investigational trial site

    Essen

  • SIRN investigational trial site

    Halle

  • SIRN investigational trial site

    Löwenstein

  • SIRN investigational trial site Johannes Gutenberg Universität

    Mainz

  • SIRN investigational trial site Katholisches Klinikum

    Mainz

  • SIRN investigational trial site

    Rotenburg (Wümme)

Other trials in Germany

About this study

Official title: A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment Following Resection of Non-small Cell Lung Carcinoma (NSCLC) in Patients Not Eligible for Cisplatin-based Adjuvant Chemotherapy

This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment following surgery for NSCLC.

The primary hypothesis is to increase the progression-free survival (PFS) of the experimental group in comparison to a historical control group. For sample size calculation a 2 year PFS of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated for the intervention group. These estimates are based on the actual PFS and overall survival (OS) of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to published international results, and the improvement of PFS achieved by 4 cycles of cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.

Being tested
Sorafenib
Keywords
Sorafenib, NSCLC, Adjuvant Treatment, resected Non-Small Cell Lung Carcinoma
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.

  • SorafenibDrug

    Also called Nexavar

    Sorafenib will be administered as oral formulation (200 mg tablets) at a dose of 400 mg twice daily starting 28 to 42 days after surgery or surgery plus adjuvant radiotherapy. The dose may be adjusted based on individual toxicities following a predetermined dose reduction schedule. Sorafenib therapy will be continued for 48 months, or until disease progression, patient refusal or intolerable toxicity, whichever comes first. Patients in remission after 48 months will be offered continued Sorafenib treatment in a roll-over study.

Study groups in NCT00532025
Study groupRoleWhat they receive
1ExperimentalSorafenib treatment
Receives: Drug: Sorafenib

What is being measured

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

  1. Progression-free survival (PFS) clinical and radiological assessment of remission status (RECIST criteria)

    Measured: 2 years

Secondary outcomes (4)

  1. Progression free survival

    Measured: 3 and 4 years

  2. Overall survival

    Measured: 3 and 4 years

  3. Assessment of safety and tolerability of Sorafenib when administered as adjuvant treatment following surgery for NSCLC

    Measured: 2, 3 and 4 years

  4. Assessment of biomarkers relevant to Sorafenib response and disease state, and their correlation to clinical outcome

    Measured: 4 years

Timeline

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

  1. First posted19 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

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
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532025
Sponsor's protocol ID
SIRN-TOM1 KKS 2006-010
Acronym
SIRN
Status last verified
Jul 2009
First submitted
18 Sep 2007
Last updated
28 Jul 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib in people with Carcinoma, Non-Small-Cell Lung, run by Johannes Gutenberg University Mainz at 6 sites in Germany.

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 17 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: stopped early, as of the sponsor's last update on 28 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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 was stopped early. 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?

Progression-free survival (PFS) clinical and radiological assessment of remission status (RECIST criteria) (time frame: 2 years). 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 NCT00532025.

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 28 Jul 2009; AzTrials last refreshed its copy on 6 Nov 2026.

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