Effectiveness and Safety of Adding Bevacizumab to First Line Chemotherapy in Lung Cancer Patients With Stable Disease

NCT03240549 | Unknown Phase 2 FDA Drug

• 1 other identifier: 121-2016007
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

advanced pulmonary adenocarcinoma; Bevacizumab; First line chemotherapy; Stable disease

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The percentage of patients who was assessed as complete response and partial response according RECIST (Response Evaluation In Solid Tumors).

  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 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 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.

  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.

  Assessment should be done from the written consent to the finish of this study, assessed up to 36 months.

Study Arms (2)

conventional therapy group

NO INTERVENTION

Treatment with previous regimen of combined chemotherapy

bevacizumab group

EXPERIMENTAL

Adding bevacizumab to the previous regimen of combined chemotherapy

Drug: bevacizumab

Interventions

bevacizumab DRUG

The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.

Also known as: avastin

bevacizumab group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Hospital: lead

Related Publications (2)

• 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.

  PMID: 17167137 BACKGROUND

• Ai 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.

  PMID: 33073527 DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yixin Zeng, Doctor

  Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Bin Ai, Docter

CONTACT

+86 10 85132542; docaibin@163.com

Xu Li, Master

CONTACT

+86 10 85136714; li-xu@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 7, 2017
• Study Start: August 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: September 30, 2019
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share