Non-small Cell Lung Cancer MetastaticPhase 2NCT03240549
Effectiveness and Safety of Adding Bevacizumab to First Line Chemotherapy in Lung Cancer Patients With Stable Disease
A Phase 2 study testing bevacizumab in people with Non-small Cell Lung Cancer Metastatic, run by Beijing Hospital.
Trial summary
Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to 30 Sep 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent;
- Age ≥18 years old, ≤75 years old;
- Histologically or cytologically confirmed lung adenocarcinoma that can not treated with surgery with locally advanced (stage IIIb) or metastatic (IV) disease. Do not accept the diagnosis of lung adenocarcinoma alone based on sputum cytology;
- Patients who have undergone targeted therapy for stage of disease (stage III, stage IV, stage IV) have not received treatment for advanced disease chemotherapy for patients with mutations associated with driving genes (eg, EGFR(epidermal growth factor receptor) mutations, ALK(anaplastic lymphoma kinase) gene fusion, etc.) could be included;
- Patients who have received adjuvant or neoadjuvant therapy for non-metastatic lesions can be enrolled for more than 12 months at the beginning of the study treatment;
- Patients who have measurable lesions according to RECIST 1.1;
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- First line chemotherapy is platinum combined with pemetrexed or paclitaxel;
- Stable disease after 2 cycles chemotherapy;
- Eastern Cooperative Oncology Group performance Status of 0 or 1;
- Life expectancy ≥12 weeks;
- There was no dose adjustment due to toxicity during the previous 2 cycles of combination chemotherapy;
- The time delay is not more than 2 weeks due to toxicity of previous chemotherapy;
- Adequate hematological function:ANC≥1.5 x 109/L，PLT≥100 x 109/L，Hb≥9 g/dL；
- Adequate liver function:
- Total bilirubin <1.5x ULN(the upper limit of the normal value), and
- for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times ULN; for patients with liver metastases, both were less than 5 times ULN;
- Adequate renal function:
- serum creatinine is equal to or less than 1.5 times ULN (upper limit of normal), - or creatinine clearance calculated value is greater than or equal to 60ml/min, and
- routine urine urine protein negative or 24 hour urinary protein quantity is less than or equal to 1g;
- Within 7 days before treatment, the international normalized ratio (INR) is less or equal to 1.5 times ULN, and partial thromboplastin time (PTT or aPTT) less than 1.5 times ULN;
Who cannot join
- Mixed non-small cell and small cell carcinoma, large cell carcinoma, adenosquamous carcinoma;
- Within 3 months before the election has a clear history of hemoptysis, that is, a single hemoptysis more than 2ml blood;
- Images show signs of tumor invasion into the large blood vessels;
- Patients with symptomatic central nervous system metastasis or intratumoral hemorrhage, the patient can not be selected regardless of whether or not to receive the relevant treatment;
- Received chest radiotherapy within 28 days prior to enrollment;
- Received a large number of surgical operations (including thoracotomy biopsy) or have a major trauma within 28 days prior to enrollment;
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- Current or resent (within the first 10 days of receiving the first dose bevacizumab) using aspirin (> 325 mg / day);
- Current or recent (within the first 10 days of receiving the first dose bevacizumab) the use of full dose oral or parenteral anticoagulant or thrombolytic therapy.Allow prophylactic use of anticoagulants;
- Medical history or examination results indicate that patients with hereditary bleeding tendency or coagulopathy may increase the risk of bleeding;
- Uncontrolled hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg);
- Previous hypertensive crisis or hypertensive encephalopathy patients;
- Cardiovascular disease with clinical significance, including but not limited to CVA(cerebral vascular accident) or TIA（transient ischemic attack） (≤ 6 months before admission), myocardial infarction (≤ 6 months before enrollment), unstable angina, New York Heart Association classification ≥ Class II Congestive heart failure, need to be treated during the study and may interfere with the study of treatment, or drug can not control the serious arrhythmia;
- Significant vascular disease (including but not limited to aortic aneurysm or proximal arterial thrombosis requiring surgery repair) within 6 months prior to enrollment;
- Non-curative wounds, active peptic ulcers or fractures;
- There was a history of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months of enrollment;
- Women who had a complete uterus (except for menopausal status over the last 24 months) during the six months after the study and at the last administration of bevacizumab, but did not use effective contraceptive methods (no contraindications to use background chemotherapy Drugs in the case of oral contraceptives, intrauterine devices, barrier contraceptives combined with spermicidal gels or sterilization surgery). During the study period and the last administration of bevacizumab within 90 days, men who did not agree to use effective contraceptive methods;
- Pregnant and lactating women;
- Received any other test medication or participated in another clinical trial within 28 days prior to enrollment;
- Known hypersensitivity to bevacizumab or any of its excipients and any chemotherapeutic ingredients;
- Signs of persistent or active infection requiring intravenous antibiotic therapy; other diseases, neurological or metabolic dysfunction; contraindications in the results of medical examination or laboratory findings or the use of a study drug or a patient at a high risk of treating the high risk associated with complications Suspicious disease or symptoms;
- Tracheal - esophageal fistula or bronchial - pleural fistula;
- Malignant tumor other than NSCLC within 5 years before enrollment, except for the adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer and ductal carcinoma in situ after radical resection;
- Medical history or examination results showed thrombotic disease within 6 months before enrollment;
- Patients with mental illness or no self-judgment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of Adding Bevacizumab to Chemotherapy in Patients With Advanced Lung Adenocarcinoma With Stable Disease After 2 Cycles of First Line Combination Chemotherapy: a Multicenter, Prospective Cohort Study
Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.
Read the detailed description
Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.
So a prospective cohort study has been designed to confirm this hypothesis, patients with advanced pulmonary adenocarcinoma who are stable after two cycles of platinum-based combination chemotherapy are objects of this study, and they can choose to continue the previous treatment regimen according to the guideline or adding bevacizumab to the regimen independently until the progression or intolerance of toxicity, or 4 to 6 cycles of chemotherapy in stable disease. The objective response rate in these two groups who received different treatment is the primary endpoint and the toxicity, quality of life, the progression free survival are the second endpoints.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- bevacizumab
- Keywords
- advanced pulmonary adenocarcinoma, Bevacizumab, First line chemotherapy, Stable disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Also called avastin
The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| conventional therapy group | No intervention | Treatment with previous regimen of combined chemotherapy |
| bevacizumab group | Experimental | Adding bevacizumab to the previous regimen of combined chemotherapy Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The percentage of patients who was assessed as complete response and partial response according RECIST (Response Evaluation In Solid Tumors).
Measured: Assessment of the response should be done from the written consent to the 3 month after the last patient inrolled in the study, assessed up to 24 months.
Secondary outcomes (4)
Duration of Response Duration of Response
The duration in responsive patients from the first remission to the progression.
Measured: The start point was the first remission until the date of first documented progression or date of death from any cause, which came first, assessed up to 30 months.
Progression Free Survival.
The time from the day written consent to the first date of objective progression or death from any cause.
Measured: The progression free survival was start from the written consent to the date of first documented progression or date of death from any cause, which came first,assessed up to 30 months.
Adverse Effects.
The adverse effects of the treatment especially in hematology,cardiovascular system and renal system according the CTCAE 4.0, and the SAE(serious adverse events) in the treatment and follow up.
Measured: Assessment should be done from the written consent to the date 28 days after the last chemotherapy, assessed up to 24 months.
Quality of Life.
The quality of life should be assessed in the study using FACT-L(Functional Assessment of Cancer Therapy - Lung).
Measured: Assessment should be done from the written consent to the finish of this study, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startAug 2017 (estimated)
- Primary completion31 Aug 2018 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bin Ai, Beijing Hospital
- Investigators
- Yixin Zeng, Doctor, Study chair, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240549
- Sponsor's protocol ID
- 121-2016007
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
PubMed 17167137Ai B, Zhang L, Huang D, Chen J, Liu Z, Hu X, Zhou S, Hu Y, Zhao J, Yang F. Efficacy and safety of bevacizumab in advanced lung adenocarcinoma patients with stable disease after two cycles of first-line chemotherapy: A multicenter prospective cohort study. Thorac Cancer. 2020 Dec;11(12):3641-3644. doi: 10.1111/1759-7714.13687. Epub 2020 Oct 19.
PubMed 33073527
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Adding Bevacizumab to Chemotherapy in Patients With Advanced Lung Adenocarcinoma With Stable Disease After 2 Cycles of First Line Combination Chemotherapy: a Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03240549
- Acronym / sponsor ID
- 121-2016007
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- advanced pulmonary adenocarcinoma, Bevacizumab, First line chemotherapy, Stable disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- Aug 2017 (estimated)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 7 Aug 2017 (actual)
- 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.
Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.
Detailed description
Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.
So a prospective cohort study has been designed to confirm this hypothesis, patients with advanced pulmonary adenocarcinoma who are stable after two cycles of platinum-based combination chemotherapy are objects of this study, and they can choose to continue the previous treatment regimen according to the guideline or adding bevacizumab to the regimen independently until the progression or intolerance of toxicity, or 4 to 6 cycles of chemotherapy in stable disease. The objective response rate in these two groups who received different treatment is the primary endpoint and the toxicity, quality of life, the progression free survival are the second endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| conventional therapy group | No intervention | –Treatment with previous regimen of combined chemotherapy |
| bevacizumab group | Experimental | Drug: bevacizumabAdding bevacizumab to the previous regimen of combined chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent;
- Age ≥18 years old, ≤75 years old;
- Histologically or cytologically confirmed lung adenocarcinoma that can not treated with surgery with locally advanced (stage IIIb) or metastatic (IV) disease. Do not accept the diagnosis of lung adenocarcinoma alone based on sputum cytology;
- Patients who have undergone targeted therapy for stage of disease (stage III, stage IV, stage IV) have not received treatment for advanced disease chemotherapy for patients with mutations associated with driving genes (eg, EGFR(epidermal growth factor receptor) mutations, ALK(anaplastic lymphoma kinase) gene fusion, etc.) could be included;
- Patients who have received adjuvant or neoadjuvant therapy for non-metastatic lesions can be enrolled for more than 12 months at the beginning of the study treatment;
Key exclusion criteria (24 listed)
- Mixed non-small cell and small cell carcinoma, large cell carcinoma, adenosquamous carcinoma;
- Within 3 months before the election has a clear history of hemoptysis, that is, a single hemoptysis more than 2ml blood;
- Images show signs of tumor invasion into the large blood vessels;
- Patients with symptomatic central nervous system metastasis or intratumoral hemorrhage, the patient can not be selected regardless of whether or not to receive the relevant treatment;
- Received chest radiotherapy within 28 days prior to enrollment;
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: avastinThe patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen. | Drug | bevacizumab group |
Primary outcome
Objective Response Rate
Time frame: Assessment of the response should be done from the written consent to the 3 month after the last patient inrolled in the study, assessed up to 24 months.
The percentage of patients who was assessed as complete response and partial response according RECIST (Response Evaluation In Solid Tumors).
4 secondary outcomes
Duration of Response Duration of Response
Time frame: The start point was the first remission until the date of first documented progression or date of death from any cause, which came first, assessed up to 30 months.
Progression Free Survival.
Time frame: The progression free survival was start from the written consent to the date of first documented progression or date of death from any cause, which came first,assessed up to 30 months.
Adverse Effects.
Time frame: Assessment should be done from the written consent to the date 28 days after the last chemotherapy, assessed up to 24 months.
Quality of Life.
Time frame: Assessment should be done from the written consent to the finish of this study, assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Background: PubMed 17167137Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
- Derived from this study: PubMed 33073527Ai B, Zhang L, Huang D, Chen J, Liu Z, Hu X, Zhou S, Hu Y, Zhao J, Yang F. Efficacy and safety of bevacizumab in advanced lung adenocarcinoma patients with stable disease after two cycles of first-line chemotherapy: A multicenter prospective cohort study. Thorac Cancer. 2020 Dec;11(12):3641-3644. doi: 10.1111/1759-7714.13687. Epub 2020 Oct 19.
- Individual participant dataSharing planned: No
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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.
Yixin Zeng, Doctor study chair
Beijing Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab in people with Non-small Cell Lung Cancer Metastatic, run by Beijing Hospital.
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 20 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 7 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Ai, Docter (+86 10 85132542, docaibin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Assessment of the response should be done from the written consent to the 3 month after the last patient inrolled in the study, assessed up to 24 months.). 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 NCT03240549, which also lists 2 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 7 Aug 2017.