Lung CancerPhase 2NCT00354549
Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC
A Phase 2 study testing bevacizumab + erlotinib hydrochloride and gemcitabine hydrochloride + cisplatin or carboplatin in people with Lung Cancer, run by Swiss Cancer Institute at 2 sites in Switzerland.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bevacizumab + erlotinib hydrochloride and gemcitabine hydrochloride + cisplatin or carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 104 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2006to Sep 2010
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
- Newly diagnosed or recurrent disease
- Meets 1 of the following staging criteria:
- Stage IIIB disease, meeting both of the following criteria:
- Proven malignant effusion or supraclavicular node involvement (i.e., N3 supraclavicular nodes)
- Not a candidate for curative multimodality treatment or surgery
- Stage IV disease
- Measurable disease, defined as ≥ 1 lesion (outside of irradiated areas) that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI
- Immediate chemotherapy not clinically mandatory in the judgement of the investigator
- No intrathoracic large, centrally located tumors and/or cavitary lesions invading or abutting major blood vessels
- No evidence of clinically active interstitial lung disease
- Patients with chronic stable radiographic changes who are asymptomatic are eligible
- No small cell lung cancer (SCLC), squamous NSCLC, or combined SCLC-NSCLC tumors
- No brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin ≥ 10 g/dL
- Absolute neutrophil count ≥ 1,500/mm³
- Thrombocyte count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
- Quick ≥ 70% OR INR ≤ 1.5
- Creatinine ≤ 2.0 times ULN
- Proteinuria ≤ 2+ by urine dipstick
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- Able to understand trial information given by the investigator and complete quality of life questionnaire
- No pre-existing condition that would preclude swallowing and/or absorption of oral medication
- No prior or concurrent malignancies, except for the following:
- Malignancy for which the minimum relapse-free interval is ≥ 5 years
- Nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- No other medical condition that would preclude study participation, including any of the following:
- Unstable or uncompensated respiratory, cardiac, hepatic, or renal disease
- Active infection
- Uncontrolled diabetes mellitus
- Hypertension ≥ 150/100 mm Hg despite treatment
- Myocardial infarction within the past 3 months
- History of hemorrhagic disorders
- Non-healing wound, ulcer, or bone fracture
- No clinical history of coagulopathy or thrombosis
- No hemoptysis or hematemesis ≥ grade 2 (defined as bright red blood of ≥ 5 mL per episode) within the past 6 months
- No known hypersensitivity to study drug(s) or to any other component of the study drugs
- No significant traumatic injury within the past 28 days
- No serious underlying medical condition that would impair the ability of the patient to participate in the trial or that would preclude use of study drugs
- No cerebrovascular accident or other CNS bleeding within the past 6 months
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to lesion(s) selected for measurement
- No prior chemotherapy for advanced disease
- At least 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC
- Prior intrapleural or intrapericardial local chemotherapy allowed
- No prior endothelial growth factor and/or vascular endothelial growth factor (receptor)-targeted therapy for NSCLC
- More than 28 days since prior major surgical procedure or open biopsy
- More than 30 days since prior treatment in another clinical trial
- No concurrent anticoagulants (e.g., phenprocoumon, acenocoumarol, or full-dose warfarin or heparin)
- No concurrent full-dose continuous use of non-steroid anti-inflammatory drugs (NSAIDs)
- No concurrent aspirin or clopidogrel bisulfate
- Low-dose aspirin (≤ 325 mg daily) may be continued in patients at high risk for arterial thromboembolic disease
- No other concurrent drugs contraindicated for use with the study drugs, according to the Swissmedic-approved product information
- No other concurrent experimental drugs or anticancer therapy, including chemotherapy, immunotherapy, or hormone therapy
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitaetsspital-Basel
Basel, CH-4031
Oncology Institute of Southern Switzerland
Bellinzona, CH-6500
About this study
Official title: Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine at disease progression may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).
Secondary
- Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in these patients.
- Assess the quality of life (QOL) in patients treated with bevacizumab and erlotinib hydrochloride.
- Assess the efficacy and safety of subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride in patients who have disease progression.
- Assess the QOL in patients treated with subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride at disease progression.
Tertiary
- Identify novel biomarkers in predicting response to therapy and toxicity in patients treated with bevacizumab and erlotinib hydrochloride as initial therapy.
OUTLINE: This is a multicenter, prospective, open-label study.
Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Beginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and periodically during study treatment.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 101 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab + erlotinib hydrochloride, gemcitabine hydrochloride + cisplatin or carboplatin
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab + erlotinib hydrochlorideDrug
Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
gemcitabine hydrochloride + cisplatin or carboplatinDrug
Beginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride
Measured: 12 weeks
Secondary outcomes (11)
DS as assessed by RECIST criteria after 6 and 18 weeks of treatment with bevacizumab and erlotinib hydrochloride
Measured: 6 and 18 weeks
Objective response (CR or PR) as assessed by RECIST criteria after 6, 12, and 18 weeks of treatment with bevacizumab and erlotinib hydrochloride
Measured: 6, 12 and 18 weeks
Best overall response when treated with bevacizumab and erlotinib hydrochloride
Measured: Until treatment ends
Adverse events (AEs) when treated with bevacizumab and erlotinib hydrochloride
Measured: Until treatment ends
Time to progression (TTP) when treated with bevacizumab and erlotinib hydrochloride
Measured: Until treatment ends
Time to treatment failure (TTF) when treated with bevacizumab and erlotinib hydrochloride
Measured: Until treatment ends
Quality of life (QOL) when treated with bevacizumab and erlotinib hydrochloride
Measured: Until treatment ends
Objective response (CR or PR) when treated with chemotherapy
Measured: Until treatment ends
Unexpected adverse drug reaction
Measured: Until treatment ends
QOL when treated with chemotherapy
Measured: Periodically
Overall survival (OS) in patients treated with bevacizumab and erlotinib hydrochloride and in patients treated with subsequent chemotherapy at disease progression
Measured: life-long
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Zappa, MD, Study chair, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354549
- Sponsor's protocol ID
- SAKK 19/05
- Other IDs
- EU-20614
- Status last verified
- May 2019
- First submitted
- 19 Jul 2006
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zappa F, Droege C, Betticher D, von Moos R, Bubendorf L, Ochsenbein A, Gautschi O, Oppliger Leibundgut E, Froesch P, Stahel R, Hess T, Rauch D, Schmid P, Mayer M, Crowe S, Brauchli P, Ribi K, Pless M; Swiss Group for Clinical Cancer Research (SAKK). Bevacizumab and erlotinib (BE) first-line therapy in advanced non-squamous non-small-cell lung cancer (NSCLC) (stage IIIB/IV) followed by platinum-based chemotherapy (CT) at disease progression: a multicenter phase II trial (SAKK 19/05). Lung Cancer. 2012 Dec;78(3):239-44. doi: 10.1016/j.lungcan.2012.08.017. Epub 2012 Sep 23.
PubMed 23009726Baty F, Joerger M, Fruh M, Klingbiel D, Zappa F, Brutsche M. 24h-gene variation effect of combined bevacizumab/erlotinib in advanced non-squamous non-small cell lung cancer using exon array blood profiling. J Transl Med. 2017 Mar 30;15(1):66. doi: 10.1186/s12967-017-1174-z.
PubMed 28359318Franzini A, Baty F, Macovei II, Durr O, Droege C, Betticher D, Grigoriu BD, Klingbiel D, Zappa F, Brutsche MH. Gene Expression Signatures Predictive of Bevacizumab/Erlotinib Therapeutic Benefit in Advanced Nonsquamous Non-Small Cell Lung Cancer Patients (SAKK 19/05 trial). Clin Cancer Res. 2015 Dec 1;21(23):5253-63. doi: 10.1158/1078-0432.CCR-14-3135. Epub 2015 Apr 28.
PubMed 25922429Joerger M, Baty F, Fruh M, Droege C, Stahel RA, Betticher DC, von Moos R, Ochsenbein A, Pless M, Gautschi O, Rothschild S, Brauchli P, Klingbiel D, Zappa F, Brutsche M. Circulating microRNA profiling in patients with advanced non-squamous NSCLC receiving bevacizumab/erlotinib followed by platinum-based chemotherapy at progression (SAKK 19/05). Lung Cancer. 2014 Aug;85(2):306-13. doi: 10.1016/j.lungcan.2014.04.014. Epub 2014 May 29.
PubMed 24928469
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT00354549
- Acronym / sponsor ID
- SAKK 19/05
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Jul 2006 (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.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine at disease progression may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).
Secondary
- Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in these patients.
- Assess the quality of life (QOL) in patients treated with bevacizumab and erlotinib hydrochloride.
- Assess the efficacy and safety of subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride in patients who have disease progression.
- Assess the QOL in patients treated with subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride at disease progression.
Tertiary
- Identify novel biomarkers in predicting response to therapy and toxicity in patients treated with bevacizumab and erlotinib hydrochloride as initial therapy.
OUTLINE: This is a multicenter, prospective, open-label study.
Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Beginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and periodically during study treatment.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 101 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bevacizumab + erlotinib hydrochloridePatients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. | Drug | – |
| gemcitabine hydrochloride + cisplatin or carboplatinBeginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Drug | – |
Primary outcome
Disease stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride
Time frame: 12 weeks
11 secondary outcomes
DS as assessed by RECIST criteria after 6 and 18 weeks of treatment with bevacizumab and erlotinib hydrochloride
Time frame: 6 and 18 weeks
Objective response (CR or PR) as assessed by RECIST criteria after 6, 12, and 18 weeks of treatment with bevacizumab and erlotinib hydrochloride
Time frame: 6, 12 and 18 weeks
Best overall response when treated with bevacizumab and erlotinib hydrochloride
Time frame: Until treatment ends
Adverse events (AEs) when treated with bevacizumab and erlotinib hydrochloride
Time frame: Until treatment ends
Time to progression (TTP) when treated with bevacizumab and erlotinib hydrochloride
Time frame: Until treatment ends
Time to treatment failure (TTF) when treated with bevacizumab and erlotinib hydrochloride
Time frame: Until treatment ends
Quality of life (QOL) when treated with bevacizumab and erlotinib hydrochloride
Time frame: Until treatment ends
Objective response (CR or PR) when treated with chemotherapy
Time frame: Until treatment ends
Unexpected adverse drug reaction
Time frame: Until treatment ends
QOL when treated with chemotherapy
Time frame: Periodically
Overall survival (OS) in patients treated with bevacizumab and erlotinib hydrochloride and in patients treated with subsequent chemotherapy at disease progression
Time frame: life-long
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Results publication: PubMed 23009726Zappa F, Droege C, Betticher D, von Moos R, Bubendorf L, Ochsenbein A, Gautschi O, Oppliger Leibundgut E, Froesch P, Stahel R, Hess T, Rauch D, Schmid P, Mayer M, Crowe S, Brauchli P, Ribi K, Pless M; Swiss Group for Clinical Cancer Research (SAKK). Bevacizumab and erlotinib (BE) first-line therapy in advanced non-squamous non-small-cell lung cancer (NSCLC) (stage IIIB/IV) followed by platinum-based chemotherapy (CT) at disease progression: a multicenter phase II trial (SAKK 19/05). Lung Cancer. 2012 Dec;78(3):239-44. doi: 10.1016/j.lungcan.2012.08.017. Epub 2012 Sep 23.
- Results publication: PubMed 28359318Baty F, Joerger M, Fruh M, Klingbiel D, Zappa F, Brutsche M. 24h-gene variation effect of combined bevacizumab/erlotinib in advanced non-squamous non-small cell lung cancer using exon array blood profiling. J Transl Med. 2017 Mar 30;15(1):66. doi: 10.1186/s12967-017-1174-z.
- Results publication: PubMed 25922429Franzini A, Baty F, Macovei II, Durr O, Droege C, Betticher D, Grigoriu BD, Klingbiel D, Zappa F, Brutsche MH. Gene Expression Signatures Predictive of Bevacizumab/Erlotinib Therapeutic Benefit in Advanced Nonsquamous Non-Small Cell Lung Cancer Patients (SAKK 19/05 trial). Clin Cancer Res. 2015 Dec 1;21(23):5253-63. doi: 10.1158/1078-0432.CCR-14-3135. Epub 2015 Apr 28.
- Results publication: PubMed 24928469Joerger M, Baty F, Fruh M, Droege C, Stahel RA, Betticher DC, von Moos R, Ochsenbein A, Pless M, Gautschi O, Rothschild S, Brauchli P, Klingbiel D, Zappa F, Brutsche M. Circulating microRNA profiling in patients with advanced non-squamous NSCLC receiving bevacizumab/erlotinib followed by platinum-based chemotherapy at progression (SAKK 19/05). Lung Cancer. 2014 Aug;85(2):306-13. doi: 10.1016/j.lungcan.2014.04.014. Epub 2014 May 29.
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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.
Francesco Zappa, MD study chair
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab + erlotinib hydrochloride and gemcitabine hydrochloride + cisplatin or carboplatin in people with Lung Cancer, run by Swiss Cancer Institute at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride (time frame: 12 weeks). 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 NCT00354549, which also lists 4 linked publications.
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 15 May 2019.