Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabine/Cisplatin Plus Bevacizumab
INNOVATIONS
2 other identifiers
interventional
224
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 12, 2013
June 1, 2013
3.8 years
September 27, 2007
June 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The main efficacy parameter is the progression free survival.
Recruitment 1 year, Follow up 2 years
Secondary Outcomes (4)
Overall survival
Recruitment 1 year, Follow up 2 years
Quality of life
Screening, prior to next treatment cycle, treatment day 126, end of therapy
Response rate
Screening, prior to treatment cycle 3, prior to treatment clycle 5, treatment day 126, every 6 weeks after treatment day 126, end of therapy
Molecular investigations
Screening, prior to treatment cycle 3
Study Arms (2)
Arm A (Erlotinib, Bevacizumab)
EXPERIMENTALArm B (Gemcitabine, Cisplatin, Bevacizumab)
ACTIVE COMPARATORInterventions
15mg/kg i.v. on day 1 (three-week cycle) until tumor progression
1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles
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)
Eligibility Criteria
You may qualify if:
- 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%)
- 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
- +16 more criteria
You may not qualify if:
- 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
- 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)
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aktion Bronchialkarzinom e.V.lead
- Roche Pharma AGcollaborator
Study Sites (37)
Klinikum Bayreuth GmbH
Bayreuth, D-95445, Germany
Charite´ Mitte
Berlin, D-10117, Germany
Gemeinschaftskrankenhaus Havelhöhe
Berlin, D-14089, Germany
Helios Klinikum Emil v. Behring
Berlin, D-14165, Germany
Augusta-Krankenanstalten
Bochum, D-44791, Germany
Johanniter-Krankenhaus Bonn
Bonn, D-53113, Germany
Forschungszentrum Borstel
Borstel, D-23845, Germany
Malteser Krankenhaus St. Hildegardis
Cologne, D-50931, Germany
St. Johannes Hospital
Duisburg, D-47166, Germany
Städtisches Krankenhaus Frankfurt-Höchst
Frankfurt, D-65929, Germany
Klinikum Frankfurt (Oder)GmbH
Frankfurt (Oder), D-15232, Germany
Krankenhaus Nordwest
Frankfurt am Main, D-60488, Germany
Medizinisches Versorgungszentrum Osthessen
Fulda, D-36043, Germany
Georg-August-Universität Göttingen
Göttingen, D-37075, Germany
Universitätsklinikum Greifswald
Greifswald, D-17487, Germany
Krankenhaus Großhansdorf
Großhansdorf, D-22927, Germany
Diakoniekrankenhaus Halle/S.
Halle, D-06114, Germany
Asklepios Klinik Harburg
Hamburg, D-21075, Germany
Thoraxklinik Universitätsklinikum Heidelberg
Heidelberg, D-69126, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Fachklinik für Lungenerkrankungen Immenhausen
Immenhausen, D-34376, Germany
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, D-76137, Germany
Klinikum Kassel GmbH
Kassel, 34125, Germany
Katholisches Klinikum Haus Marienhof
Koblenz, 56073, Germany
Onkologische Schwerpunktpraxis Dr. Lothar Müller
Leer, D-26789, Germany
Klinikum Lippe-Lemgo
Lemgo, D-32657, Germany
Klinik Löwenstein
Löwenstein, 74245, Germany
Klinikum Ludwigshafen
Ludwigshafen, D-67063, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, D-23538, Germany
St. Hildegardis Krankenhaus
Mainz, D-55131, Germany
Universitätsklinikum Marburg
Marburg, D-35033, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Krankenhaus Barmherzige Brüder
Regensburg, D-93049, Germany
Hanse-Klinikum Stralsund
Stralsund, D-18410, Germany
Onkologische Gemeinschaftspraxis Dr. Nusch
Velbert, D-42551, Germany
Fachkliniken Wangen
Wangen, D-88239, Germany
Helios Klinikum Wuppertal
Wuppertal, D-42283, Germany
Related Publications (1)
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.
PMID: 25792638DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Dr. Martin Wolf, MD
Aktion Bronchialkarzinom e.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2007
First Posted
September 28, 2007
Study Start
November 1, 2007
Primary Completion
August 1, 2011
Study Completion
May 1, 2012
Last Updated
June 12, 2013
Record last verified: 2013-06