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AzTrials

Carcinoma, Non-Small-Cell LungPhase 2INNOVATIONSNCT00536640

Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabine/Cisplatin Plus Bevacizumab

A Phase 2 study testing Erlotinib, Bevacizumab and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Aktion Bronchialkarzinom e.V. at 37 sites in Germany.

Completed

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

Official record
Search all trials

Trial summary

This study wants to determine the activity of a non chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non Small Lung Cancer. 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?
Erlotinib, Bevacizumab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
37 sitesGermany
Study dates
Nov 2007to May 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 confirmed Non-Small Cell Lung Cancer that can not be treated within a defined radiological field
  • Tumor stage IIIB (pleural effusion or pericardial effusion included) or IV
  • The following histological tumor types are eligible:
  • Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation)
  • Large Cell Carcinoma (including large cell carcinomas with neuroendocrine differentiation)
  • Mixed Cell Carcinoma without small cell fraction and without predominant squamous cell fraction (< 50%)
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  • undifferentiated non-small-cell-carcinoma
  • No previous chemotherapy within the last five years
  • At least 4 weeks since last major surgery
  • Age ≥ 18 years
  • ECOG <= 2
  • Adequate hematological laboratory parameters
  • Hemoglobin ≥ 10 g/dl
  • WBC ≥ 3.000/µl
  • Platelets ≥ 100.000/µl
  • Adequate hepatic laboratory parameters
  • Bilirubin <= 2,0 mg/dl
  • AST(GOT) <= 2,5 x ULN in patients without liver metastases
  • AST(GOT) <= 5 x UNL in patients with liver metastases
  • ALT(GPT) <= 2,5 x ULN in patients without liver metastases
  • ALT(GPT) <= 5 x UNL in patients with liver metastases
  • Adequate renal laboratory parameters
  • Creatinine <= 1,5 mg/dl
  • Creatinine Clearance > 60 ml/min
  • Adequate plasmatic blood coagulation - INR <= 1,5 and PTT <= 1,5 x ULN
  • Normal cardiac function defined by LVEF > 49% (echocardiography)
  • Electrocardiogram without significant signs of cardiac arrhythmias
  • Provision of informed consent according to local regulatory requirements prior to any protocol specific treatment
  • Measurable lesion according to RECIST-Criteria's
  • Negative pregnancy test for women of childbearing potential unless they are postmenopausal at baseline. (Postmenopausal women must have been amenorrheic at least for 12 months to be considered of non childbearing potential)
  • Women of child bearing potential to must be willing to use an acceptable method to avoid pregnancy at least one month before study start. Examples: oral contraceptives (sole application of oral contraceptives is not sufficient), diaphragm pessary, intrauterine device (spiral), condom plus diaphragm pessary plus spermicide

Who cannot join

  • Histologic confirmed squamous cell carcinoma
  • Pregnancy or lactation period
  • Tumor extension treatable with radiotherapy
  • Current clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan
  • Evidence of tumor invading or abutting major blood vessels
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of a CIS of the cervix or non-melanomatous skin cancer. Patients curatively treated and free of disease for at least 5 years will be discussed with the Principal Investigator (LKP) before inclusion
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  • Any previous chemotherapy within the last five years
  • Any radiotherapy with exception of the following situations:
  • concomitant small field radiotherapy in the case of solitary bone metastases or other solitary metastases
  • in case of large field radiotherapy or multi-radiation fields due to multiple bone metastases or other metastases. The application of study medication then must be delayed at least for 24 h (after last radiotherapy)
  • in case of radiotherapy of the primary tumor trial therapy can be employed if radiotherapy has ended at least 6 weeks ago and new tumor progression is clearly documented
  • Treatment with an investigational new drug, currently or within the last 28 days, and/or participation in another clinical trial, currently or during the last 12 weeks, and/or previous participation in this study
  • A history or presence of any CNS disorder or psychiatric disability judged by the Investigator to be clinically significant and/or interfering with compliance of oral drug intake
  • Patients with any clinically significant disease that in the opinion of the investigator is likely to put the patient at risk or to interfere with the evaluation of the patient's safety and of the study outcome. This includes, but is not limited to:
  • Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
  • Immediate need for therapeutic intervention (e.g.: upper inflow congestion or poststenotic pneumonia)
  • Clinically significant cardiac disease (e.g. right-sided heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
  • pleural effusion or pericardial effusion with the need for intervention
  • Uncontrolled hypertension
  • Non healing wound, ulcer or bone fracture
  • Fresh thrombosis under therapy with anticoagulants
  • Hemorrhagic diathesis, Hemophilia A, Hemophilia B
  • Implantation of a central vein catheter (Prot-Catheter) within 24 h prior to application of study medication
  • Present hemoptysis of any CTC grade or history of hemoptysis of any CTC grade within 3 month prior to study start
  • Peritoneal carcinomatosis
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to study start
  • Interstitial pneumonia or extensive or symptomatic interstitial fibrosis of the lung
  • Pleural effusion or ascites, which cause respiratory compromise
  • Any other active or uncontrolled infection
  • Organ allograft
  • History of a mental disease or condition such as to interfere with the patient's ability to understand the requirements of the study and the intake of study medication according to study protocol
  • Inability to swallow pills
  • Current or recent (within 10 days of first dose of study medication) use of coumadin/warfarin or marcumar/phenprocoumon for therapeutic purposes Prophylactic use of low molecular weight heparins is allowed
  • Current or recent (within 10 days of first dose of study medication) use of ASS - Dosage > 325 mg/day
  • Current or recent (within 10 days of first dose of study medication) use of Plavix/Clopidogrel
  • Alcohol and drug abuse
  • Known hypersensitivity to any of the study drugs
  • Presence of a tracheobronchial fistula or fistulization in other organ systems like gastrointestinal fistulas or fistulization of urogenital tract

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Germany37 sites

  • Klinikum Bayreuth GmbH

    Bayreuth, D-95445

  • Charite´ Mitte

    Berlin, D-10117

  • Gemeinschaftskrankenhaus Havelhöhe

    Berlin, D-14089

  • Helios Klinikum Emil v. Behring

    Berlin, D-14165

  • Augusta-Krankenanstalten

    Bochum, D-44791

  • Johanniter-Krankenhaus Bonn

    Bonn, D-53113

  • Forschungszentrum Borstel

    Borstel, D-23845

  • Malteser Krankenhaus St. Hildegardis

    Cologne, D-50931

  • St. Johannes Hospital

    Duisburg, D-47166

  • Städtisches Krankenhaus Frankfurt-Höchst

    Frankfurt, D-65929

  • Klinikum Frankfurt (Oder)GmbH

    Frankfurt (Oder), D-15232

  • Krankenhaus Nordwest

    Frankfurt am Main, D-60488

  • Medizinisches Versorgungszentrum Osthessen

    Fulda, D-36043

  • Georg-August-Universität Göttingen

    Göttingen, D-37075

  • Universitätsklinikum Greifswald

    Greifswald, D-17487

  • Krankenhaus Großhansdorf

    Großhansdorf, D-22927

  • Diakoniekrankenhaus Halle/S.

    Halle, D-06114

  • Asklepios Klinik Harburg

    Hamburg, D-21075

  • Thoraxklinik Universitätsklinikum Heidelberg

    Heidelberg, D-69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Fachklinik für Lungenerkrankungen Immenhausen

    Immenhausen, D-34376

  • St. Vincentius-Kliniken Karlsruhe

    Karlsruhe, D-76137

  • Klinikum Kassel GmbH

    Kassel, 34125

  • Katholisches Klinikum Haus Marienhof

    Koblenz, 56073

  • Onkologische Schwerpunktpraxis Dr. Lothar Müller

    Leer, D-26789

  • Klinikum Lippe-Lemgo

    Lemgo, D-32657

  • Klinik Löwenstein

    Löwenstein, 74245

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, D-23538

  • Klinikum Ludwigshafen

    Ludwigshafen, D-67063

  • St. Hildegardis Krankenhaus

    Mainz, D-55131

  • Universitätsklinikum Marburg

    Marburg, D-35033

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Krankenhaus Barmherzige Brüder

    Regensburg, D-93049

  • Hanse-Klinikum Stralsund

    Stralsund, D-18410

  • Onkologische Gemeinschaftspraxis Dr. Nusch

    Velbert, D-42551

  • Fachkliniken Wangen

    Wangen, D-88239

  • Helios Klinikum Wuppertal

    Wuppertal, D-42283

Other trials in Germany

About this study

Official title: Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabin/Cisplatin Plus Bevacizumab

This study wants to determine the activity of a non chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non Small Lung Cancer.

Read the detailed description

Prospective, randomized multi-center, open label phase II study to determine the activity of a non-chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non-Small-Lung-Cancer.

  • Duration of treatment/patient: up to 1,5 years
  • Follow Up: ≈ 6 month
  • Planned number of patients: 220 treated patients (110 patients/arm)
Keywords
Non Small Cell Lung Carcinoma (NSCLC Stage III an IV)
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.

  • ErlotinibDrug

    150 mg per os, given daily until tumor progression

  • BevacizumabDrug

    15mg/kg i.v. on day 1 (three-week cycle) until tumor progression

  • GemcitabineDrug

    1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles

  • CisplatinDrug

    80 mg/m2 i.v. on day 1 (three-week cycle) until tumor progression for a maximum of 6 cycles. (The administration of 40 mg/2 Cisplatin on day 1 and day 8 is also possible)

Study groups in NCT00536640
Study groupRoleWhat they receive
Arm A (Erlotinib, Bevacizumab)ExperimentalNot described
Receives: Drug: Erlotinib; Drug: Bevacizumab
Arm B (Gemcitabine, Cisplatin, Bevacizumab)Active comparatorNot described
Receives: Drug: Bevacizumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. The main efficacy parameter is the progression free survival.

    Measured: Recruitment 1 year, Follow up 2 years

Secondary outcomes (4)

  1. Overall survival

    Measured: Recruitment 1 year, Follow up 2 years

  2. Quality of life

    Measured: Screening, prior to next treatment cycle, treatment day 126, end of therapy

  3. Response rate

    Measured: Screening, prior to treatment cycle 3, prior to treatment clycle 5, treatment day 126, every 6 weeks after treatment day 126, end of therapy

  4. Molecular investigations

    Measured: Screening, prior to treatment cycle 3

Timeline

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

  1. First posted28 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionAug 2011
  4. Study completionMay 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00536640
Sponsor's protocol ID
ABC-2006-NSCLC-01
Other IDs
2006-004865-32
Acronym
INNOVATIONS
Status last verified
Jun 2013
First submitted
27 Sep 2007
Last updated
12 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Thomas M, Fischer J, Andreas S, Kortsik C, Grah C, Serke M, von Eiff M, Witt C, Kollmeier J, Muller E, Schenk M, Schroder M, Villalobos M, Reinmuth N, Penzel R, Schnabel P, Acker T, Reuss A, Wolf M; ABC-Lung Cancer Group. Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer. Eur Respir J. 2015 Jul;46(1):219-29. doi: 10.1183/09031936.00229014. Epub 2015 Mar 18.

    PubMed 25792638

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib, Bevacizumab and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Aktion Bronchialkarzinom e.V. at 37 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 31 inclusion and 38 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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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 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?

The main efficacy parameter is the progression free survival. (time frame: Recruitment 1 year, Follow up 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 NCT00536640, 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 12 Jun 2013; AzTrials last refreshed its copy on 30 Oct 2026.

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