Non-Small Cell Lung CancerPhase 3NCT00130728
A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing bevacizumab and erlotinib HCl in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 4 sites in United States.
Trial summary
This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms. 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?
- bevacizumab and erlotinib HCl
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jun 2005to 23 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed written informed consent
- Cytologically or histologically confirmed NSCLC
- Clinical or radiographic progression during or after first-line chemotherapy or chemoradiotherapy for NSCLC
- Consent to provide archival tissue for analysis is required for participation in this study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Age ≥ 18 years
- Use of an acceptable means of contraception for men and women of childbearing potential
- International normalized ratio (INR) no greater than 1.3 and an aPTT no greater than the upper limits of normal within 28 days prior to enrollment for patients not on low-molecular-weight heparin or fondaparinux
Who cannot join
- Squamous cell carcinoma
- Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth Factor Receptor (EGFR) pathway or anti-angiogenesis agent
- Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
- Local palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that have not resolved to Grade 2 or less following completion of treatment
- Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
- Neurosurgery for brain metastases within 24 weeks of Day 0
Show all 23Show fewer
- Brain biopsy within 12 weeks of Day 0
- Current use of dexamethasone for treatment associated with brain metastases
- History of gross hemoptysis within 3 months prior to randomization unless definitively treated with surgery or radiation
- History of any of the following within 6 months prior to Day 0: serious systemic disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia requiring medication, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
- Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
- Progressive neurologic symptoms in patients with a history of brain metastases
- Full-dose anticoagulation with warfarin
- Chronic daily use of aspirin or other full-dose nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-platelet activity
- In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
- Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
- Anticipation of need for a major surgical procedure during the course of the study
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
- Pregnancy or breast-feeding
- Presence of another invasive cancer within 5 years prior to randomization
- Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, 21401
University Cancer & Blood Center, LLC; Research
Athens, Georgia, 30607
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kaiser Permanente - Vallejo
Vallejo, California, 94589
About this study
Official title: A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- bevacizumab, erlotinib HCl, placebo
- Keywords
- NSCLC, Avastin, Tarceva, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
erlotinib HClDrug
oral erlotinib HCl 150 mg/day orally
placeboDrug
intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| erlotinib HCl + bevacizumab | Experimental | oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle Receives: Drug: bevacizumab |
| erlotinib HCl + placebo | Placebo comparator | oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle Receives: Drug: erlotinib HCl; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) Among All Randomized Patients
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
Measured: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)
Secondary outcomes (3)
Progression-free Survival (PFS)
PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.
Measured: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)
Percentage of Participants With Objective Response
Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.
Measured: The median duration of Objective response was up to 9.7 months
Duration of Objective Response
Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.
Measured: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2005 (estimated)
- Study start8 Jun 2005
- Primary completion15 Jul 2008
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130728
- Sponsor's protocol ID
- OSI3364g
- Status last verified
- Dec 2020
- First submitted
- 12 Aug 2005
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, Vlahovic G, Soh CH, O'Connor P, Hainsworth J. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. Lancet. 2011 May 28;377(9780):1846-54. doi: 10.1016/S0140-6736(11)60545-X.
PubMed 21621716
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00130728
- Acronym / sponsor ID
- OSI3364g
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Avastin, Tarceva, Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2005 (actual)
- Primary completion
- 15 Jul 2008 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 16 Aug 2005 (estimated)
- Results
- Posted 3 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erlotinib HCl + bevacizumab | Experimental | Drug: bevacizumaboral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle |
| erlotinib HCl + placebo | Placebo comparator | Drug: erlotinib HCl, Drug: placebooral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- Cytologically or histologically confirmed NSCLC
- Clinical or radiographic progression during or after first-line chemotherapy or chemoradiotherapy for NSCLC
- Consent to provide archival tissue for analysis is required for participation in this study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Key exclusion criteria (23 listed)
- Squamous cell carcinoma
- Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth Factor Receptor (EGFR) pathway or anti-angiogenesis agent
- Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
- Local palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that have not resolved to Grade 2 or less following completion of treatment
- Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
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 |
|---|---|---|
| bevacizumabintravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle | Drug | erlotinib HCl + bevacizumab |
| erlotinib HCloral erlotinib HCl 150 mg/day orally | Drug | erlotinib HCl + placebo |
| placebointravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle | Drug | erlotinib HCl + placebo |
Primary outcome
Overall Survival (OS) Among All Randomized Patients
Time frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)
Percentage of Participants With Objective Response
Time frame: The median duration of Objective response was up to 9.7 months
Duration of Objective Response
Time frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21621716Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, Vlahovic G, Soh CH, O'Connor P, Hainsworth J. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. Lancet. 2011 May 28;377(9780):1846-54. doi: 10.1016/S0140-6736(11)60545-X.
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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.
Clinical Trials study director
Genentech, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab and erlotinib HCl in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 4 sites in United States.
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 8 inclusion and 23 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (OS) Among All Randomized Patients (time frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 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 NCT00130728, 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 14 Jan 2021.