Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    120
  • sponsor
    Fudan University
Updated on 25 January 2021

Summary

To compare the efficacy and safety of gefitinib combined with bevacizumab and gefitinib in the treatment of L858R positive mutation in exon 21 of EGFR gene in advanced NSCLC.

Details
Condition Disease-Free Survival
Treatment Gefitinib, Bevacizumab Combined With Gefitinib
Clinical Study IdentifierNCT04425187
SponsorFudan University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old, gender unlimited
NSCLC was confirmed by histology or cytology, and it was evaluated as stage IIIB-IV local advanced, recurrent or metastatic patients who could not be treated surgically. Note: the diagnosis result of NSCLC based on sputum cytology needs to be confirmed by immunohistochemistry; the current disease should be treated by radiotherapy as the first choice The subjects whose treatment strategy or follow-up target focus judged by the researchers should take radiotherapy as the first treatment strategy should not be selected
No systemic anti-tumor therapy was received for locally advanced, recurrent or metastatic NSCLC
According to the method of second-generation sequencing, L858R point mutation in exon 21 of EGFR gene was found in primary NSCLC with or without any other coexisting mutations
Within 28 days before randomization, at least one measurable lesion was selected according to the RECIST v1.1 standard (see Appendix 1); for the lesions that had previously received radiotherapy, only when there was clear disease progression 3 months after the end of radiotherapy, can they be selected as target lesions
ECoG general condition score is 0-1 (see Appendix 2)
Expected survival 12 weeks
Patients receiving radiotherapy can be included in the group if they meet the following conditions
There was no history of lung disease radiotherapy within 28 days before
randomization; L. for radiotherapy outside the chest area, the interval from
the end of final radiotherapy to at least 28 days before randomization, and
all toxic reactions have recovered
\. Good blood function within 14 days before randomization
L. the absolute neutrophil count (ANC) was 1.5 109 / L (without the support of
granulocyte colony stimulating factor) and; L lymphocyte count 0.5 109 / L
and; 1. Platelet count 100 109 / L and; Hemoglobin 9 g / dl (in order to reach
this standard, patients can receive blood transfusion)
\. Good liver function within 14 days before randomization: L) total
bilirubin 1.5 upper normal limit (ULN) and
Ast, ALT and ALP of patients without liver metastasis were less than 2.5 ULN; ast, ALT and ALP of patients with liver metastasis were less than 5 ULN
Good renal function within 14 days before randomization
Serum creatinine 1.5 ULN or calculated creatinine clearance 45 ml / min and; The urine test paper of urine protein was less than 2 +. If the baseline urine analysis of proteinuria patients is 2 +, 24-hour urine sample collection must be completed, and 24-hour urine protein 1 g; serum albumin 25 g / L
Within 14 days before randomization, INR 1.5 ULN, APTT 1.5 ULN. 13. Heart function meets the requirement of left ventricular ejection fraction (LVEF) 50%
Fertile women: during the treatment period and within 6 months after the last administration, they agreed to abstinence (no heterosexual sexual intercourse) or use contraceptive methods (contraceptive methods with a failure rate of less than 1%). If a postmenopausal woman has not reached the postmenopausal state (menopausal time 12 months, no other reason except menopause) and has not undergone sterilization (removal of ovaries and / or uterus), she is defined as a woman with fertility
Male: for male patients with fertility of female partners or pregnancy of female partners, they agree to abstinence (no heterosexual sexual intercourse) or use condoms within 6 months after the last administration, and agree not to donate sperm
Sign the informed consent voluntarily. 17. The researchers judged that they could comply with the research plan
\-

Exclusion Criteria

Histology or cytology confirmed mixed adenocarcinoma with squamous cells as the main component (the proportion of squamous cells 10%)
There was a history of malignancy (except NSCLC) in the first 5 years before randomization, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, which were treated appropriately
Previous hypertensive crisis, hypertensive encephalopathy, or uncontrolled hypertension (blood pressure: systolic pressure > 150 mmHg and / or diastolic pressure > 100 mmHg)
The tumor invades the main blood vessels. Researchers or local radiologists must rule out evidence that the tumor is completely adjacent to, surrounding, or extending into the lumen of a major artery, such as the pulmonary artery or superior vena cava
Any other disease, neurological or metabolic dysfunction; medical examination or laboratory finding that a disease or condition is suspected, which prohibits the use of the test drug or exposes the patient to a high risk of treatment-related complications
It is highly suspected that there are patients with idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia, active pneumonia or active tuberculosis
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allows patients to retain catheters
History of hereditary bleeding constitution or coagulation disorder or other evidence of increased bleeding risk
There are non healing wounds, active ulcers or fractures
Patients with tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intraperitoneal abscess in the first 6 months were randomly assigned
Cardiovascular diseases with clinical significance (such as active), including but not limited to TIA (within 6 months before screening), myocardial infarction (within 6 months before screening), unstable angina, congestive heart failure with New York Heart Association classification level II (see Appendix 3), and serious arrhythmias beyond the control of drugs
Within 3 months before randomization, there was a history of hemoptysis 2 levels, that is, the blood volume of each bleeding event was > 2.5ml
Evidence of central nervous system metastasis, except for patients without any symptoms or patients with symptoms but stable condition, at least 28 days after treatment of central nervous system metastasis
Major surgery (including open biopsy) or severe trauma was performed within 28 days prior to randomization, or was expected to be performed during study treatment
Severe infections occurring within 28 days prior to randomization, including
but not limited to hospitalization for complications of infection, bacteremia
or severe pneumonia
aspirin (325 mg / day) or other non steroidal anti-inflammatory drugs known
to inhibit platelet function are currently or recently used (within 10 days
before bevacizumab was first used)
full dose oral or parenteral anticoagulants or thrombolytic agents are
currently or recently used (within 10 days prior to the first use of
bevacizumab). Preventive use of anticoagulants is permitted
\. Core biopsies or other minor operations were performed within 7 days
prior to randomization, but vascular access devices were not included
Vascular access devices should be placed at least 2 days before the start of
study treatment
\. Those who are known to be allergic to bevacizumab, gefitinib and their
excipients, or to Chinese hamster ovarian cell products or other recombinant
human or humanized antibodies
\. Those who were confirmed to be HCV positive, HIV positive, syphilis
positive, or HBsAg positive during the screening period, and whose HBV DNA
titer in the peripheral blood was 1000 copies / L
\. Pregnancy or lactation, or pregnancy planning during the study. 22. Those
who participated in any other clinical trial and took the trial drug treatment
within 30 days before randomization
\. The investigator determined that the risk of the subject was greater than
any other benefit
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