Non-Small Cell Lung CancerPhase 2NCT00312728
A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)
A Phase 2 study testing bevacizumab, First-Line Chemotherapy Agents and Second-Line Chemotherapy Agents in people with Non-Small Cell Lung Cancer and Brain Neoplasms, run by Genentech, Inc..
Trial summary
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Brain Neoplasms
- What is being tested?
- bevacizumab, First-Line Chemotherapy Agents and Second-Line Chemotherapy Agents
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jun 2009
- Phase
- Phase 2
- 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 informed consent
- Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma
- Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
- Appropriateness for first- or second-line systemic therapy for advanced NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age ≥ 18 years
- For women of childbearing potential and sexually active males, use of an accepted and effective method of contraception (e.g., hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
Who cannot join
- Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1
- Progressive neurologic symptoms
- Active malignancy other than lung cancer
- Current, recent, or planned participation in an experimental drug study
- Prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms
- Gross hemoptysis within 3 months prior to Day 1
Show all 23Show fewer
- Inadequately controlled hypertension
- Unstable angina or New York Heart Association Grade II or greater congestive heart failure (CHF)
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Myocardial infarction within 6 months prior to Day 1
- Stroke within 6 months prior to Day 1
- Active symptomatic peripheral vascular disease within 6 months prior to Day 1
- History of significant vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Known hypersensitivity to any components of bevacizumab
- Inadequate organ function
- Serious non-healing wound, ulcer, or bone fracture
- Urine protein/creatinine (UPC) ratio of ≥ 1.0
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- Pregnancy or lactation
- Known evidence of disseminated intravascular coagulation (DIC)
- Active infection or fever > 38.5°C within 3 days prior to Day 1
- Any other medical condition (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
About this study
Official title: A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.
- Conditions
- Non-Small Cell Lung Cancer, Brain Neoplasms
- Being tested
- bevacizumab, First-Line Chemotherapy Agents, Second-Line Chemotherapy Agents
- Keywords
- Brain Cancer, Brain Metastases, Avastin, NSCLC, Lung Cancer, PASSPORT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Also called Avastin
15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be < 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity.
First-Line Chemotherapy AgentsDrug
Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily.
All agents were dosed and administered per institutional standards using the respective package insert as a guideline.
Second-Line Chemotherapy AgentsDrug
Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued.
All agents were dosed and administered per institutional standards using the respective package insert as a guideline.
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | Not described Receives: Drug: bevacizumab; Drug: First-Line Chemotherapy Agents; Drug: Second-Line Chemotherapy Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage
The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage.
Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death
Measured: From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)
Secondary outcomes (5)
Overall Survival (OS) in First-line Setting
To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.
Measured: Time from enrollment to death from any cause (up to 2 years)
Number of Participants With Overall Survival (OS) in First-line Setting [1-Year or More Survival]
Number of Participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.
Measured: Time from enrollment to death from any cause (up to 2 years)
OS in First-line and Second-line Settings
To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.
Measured: Time from enrollment to death from any cause (up to 2 years)
Number of Participants With OS in First-line and Second-line Settings [1-Year or More Survival]
To assess the number of participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.
Measured: Time from enrollment to death from any cause (up to 2 years)
Number of Participants With Selected Adverse Events
Number of participants with selected adverse events (all grades based on NCI CTCAE) included any grade CNS hemorrhage, any grade pulmonary hemorrhage, any grade gastrointestinal (GI) perforation, Grade ≥ 2 arterial thromboembolic event, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 non-CNS non-pulmonary hemorrhage, Grade ≥ 3 proteinuria, Grade ≥ 3 proteinuria, Grade ≥ 3 hypertension, any serious adverse event*, and any adverse event leading to study treatment discontinuation.
*For serious adverse events, please see Adverse Event Reporting Section.
Measured: From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2009
- Study completionJun 2009
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Karlin, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312728
- Sponsor's protocol ID
- AVF3752g
- Status last verified
- Dec 2022
- First submitted
- 7 Apr 2006
- Last updated
- 6 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00312728
- Acronym / sponsor ID
- AVF3752g
- Conditions
- Non-Small Cell Lung Cancer, Brain Neoplasms
- Keywords
- Brain Cancer, Brain Metastases, Avastin, NSCLC, Lung Cancer, PASSPORT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Apr 2006 (estimated)
- Results
- Posted 22 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: bevacizumab, Drug: First-Line Chemotherapy Agents, Drug: Second-Line Chemotherapy Agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma
- Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
- Appropriateness for first- or second-line systemic therapy for advanced NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (23 listed)
- Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1
- Progressive neurologic symptoms
- Active malignancy other than lung cancer
- Current, recent, or planned participation in an experimental drug study
- Prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms
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 |
|---|---|---|
| bevacizumabAlso: Avastin15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be < 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity. | Drug | bevacizumab |
| First-Line Chemotherapy AgentsCarboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily. All agents were dosed and administered per institutional standards using the respective package insert as a guideline. | Drug | bevacizumab |
| Second-Line Chemotherapy AgentsErlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued. All agents were dosed and administered per institutional standards using the respective package insert as a guideline. | Drug | bevacizumab |
Primary outcome
Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage
Time frame: From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)
The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage. Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death
5 secondary outcomes
Overall Survival (OS) in First-line Setting
Time frame: Time from enrollment to death from any cause (up to 2 years)
Number of Participants With Overall Survival (OS) in First-line Setting [1-Year or More Survival]
Time frame: Time from enrollment to death from any cause (up to 2 years)
OS in First-line and Second-line Settings
Time frame: Time from enrollment to death from any cause (up to 2 years)
Number of Participants With OS in First-line and Second-line Settings [1-Year or More Survival]
Time frame: Time from enrollment to death from any cause (up to 2 years)
Number of Participants With Selected Adverse Events
Time frame: From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Karlin, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, First-Line Chemotherapy Agents and Second-Line Chemotherapy Agents in people with Non-Small Cell Lung Cancer and Brain Neoplasms, run by Genentech, Inc..
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 7 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Jun 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?
Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage (time frame: From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2023.