Lung CancerPhase 2NCT01588704
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
A Phase 2 study testing Neoadjuvant Bevacizumab in people with Lung Cancer, run by Si-Yu Wang at 1 site in China.
Trial summary
The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Neoadjuvant Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Apr 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
- No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
- Adequate organ and bone marrow function
Who cannot join
- Prior chemotherapy or radiation therapy for NSCLC
- Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
- Patients with known hypersensitivity to other recombinant human antibodies
- History of stroke or transient ischemic attack (TIA).
- History of myocardial infarction or unstable angina within the past 12 months.
- Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
- Women who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.
Read the detailed description
This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
- Conditions
- Lung Cancer
- Being tested
- Neoadjuvant Bevacizumab
- Keywords
- lung cancer, lung adenocarcinoma, bevacizumab, adjuvant chemotherapy, surgical resection rate, safety, feasibility
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant BevacizumabDrug
Also called Pemetrexed (Alimta), Bevacizumab (Avastin)
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Bevacizumab | Experimental | Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab. Receives: Drug: Neoadjuvant Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate
Measured: 3 months
Secondary outcomes (3)
Number of participants with perioperative complications
Measured: 4 months
Disease-free survival
Measured: 2 years
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Si-Yu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Si-Yu Wang, Doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588704
- Sponsor's protocol ID
- GASTO1001
- Other IDs
- wsy002
- Status last verified
- Jan 2015
- First submitted
- 25 Apr 2012
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01588704
- Acronym / sponsor ID
- GASTO1001
- Conditions
- Lung Cancer
- Keywords
- lung cancer, lung adenocarcinoma, bevacizumab, adjuvant chemotherapy, surgical resection rate, safety, feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Si-Yu WangUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 May 2012 (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.
The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.
Detailed description
This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Bevacizumab | Experimental | Drug: Neoadjuvant BevacizumabFour cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
- No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
- Adequate organ and bone marrow function
Key exclusion criteria (7 listed)
- Prior chemotherapy or radiation therapy for NSCLC
- Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
- Patients with known hypersensitivity to other recombinant human antibodies
- History of stroke or transient ischemic attack (TIA).
- History of myocardial infarction or unstable angina within the past 12 months.
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 |
|---|---|---|
| Neoadjuvant BevacizumabAlso: Pemetrexed (Alimta), Bevacizumab (Avastin)Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection | Drug | Neoadjuvant Bevacizumab |
Primary outcome
Resectability rate
Time frame: 3 months
3 secondary outcomes
Number of participants with perioperative complications
Time frame: 4 months
Disease-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
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 22 Jan 2015.
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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.
Si-Yu Wang, Doctor principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Bevacizumab in people with Lung Cancer, run by Si-Yu Wang at 1 site in China.
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 3 inclusion and 7 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 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Resectability rate (time frame: 3 months). 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 22 Jan 2015.