Non-small cell lung cancer
Conditions
Interventions
BevG group:bevacizumab plus gefitinib
G group:gefitib
Sponsors
first Affiliated Hospital of Third Military Medicine University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form. Able to comply with the study protocol, in the investigators judgment; 2. Histologically or cytologically documented inoperable, locally advanced (Stage IIIb who are not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-quamous; 3. An exon 19 deletion mutation or exon 21 L858R mutation has been found by ARMS test . Direct sequencing is not accepted; patients should be evaluated at least SD after first-line treatment with gefitinib; 4. Aged =12 weeks. Patients who have undergone radiotherapy may be enrolled if theymeet the following conditions: 1. The patient has no history of radiotherapy for lesions in lung fields within 28 days before the enrollment; 2. For radiotherapy outside the chest region, at least 28 days have elapsed by the time of randomization since the final irradiation date. (if the radiotherapy given as palliation to bone metastases within 2 weeks, the patient should recovery from all toxicities); 3. Measurable disease at baseline. At least one lesion is present that can be measured in accordance with the criteria in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. However, sites treated by radiotherapy should not be considered measurable.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: 1. Mixed adenosquamous carcinomas with predominantly squamous component; 2. A positive result for the exon 20 T790M mutation from any highsensitivity EGFR mutation test such as digital PCR using tumor tissue or cells; 3. Evidence of CNS metastases, except for the patients without any symptom or the patients with symptom but have stable disease for at least 28 days after treatment of CNS metastases; 4. History of haemoptysis, defined as > 2.5 ml of red blood per event within 3 months prior to randomization; 5. Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g., pulmonary artery or superior vena cava); 6. Major surgery (including open biopsy) or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during study treatment; 7. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device are excluded within 7 days prior to initiation of study treatment. Placement of a vascular access device should be at least 2 days prior to initiation of study treatment; 8. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (325 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function; 9. Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed; 10. History or evidence of inherited bleeding diathesis or coagulopathy that increases the risk of bleeding; 11. Uncontrolled hypertension (blood pressures: systolic>150 mmHg and/or diastolic >100 mmHg); 12. Prior history of hypertensive crisis or hypertensive encephalopathy; 13. Clinically significant (i.e., active) cardiovascular disease, including but not limited to cerebral vascular accident (CVA) or (transient ischemic attack) TIA (=II, or serious cardiac arrhythmia requiring medication during the study and that might interfere with regularity of the study treatment or not controlled by medication; 14. Significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; 15. Non-healing wound, active peptic ulcer, or bone fracture; 16. History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months of enrollment; 17. Pregnant or lactating, or intending to become pregnant during the study; 18. Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to join the study; 19. Known hypersensitivity to bevacizumab and Chinese hamster ovary cell products or other recombinant human or humanised antibodies or gefitinib or any of its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactZhou Xiangdong
Southwest Hospital(first Affiliated Hospital of Third Military Medicine University)
Outcome results
None listed