Phase II study of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-squamous, non-small cell lung cancer harboring activating EGFR mutations
- Conditions
- advanced EGFR mutation-positive non-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000015467
- Lead Sponsor
- Department of Thoracic Oncology Osaka Medical Center for Cardiovascular diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1)Harboring EGFR mutation of Exon20,T790M 2)Have symptomatic brain metastases or spinal metastases requiring surgical treatment or irradiation. 3)The presence of other concomitant malignancy less than 5 years disease-free interval 4)Have a pleural effusion, ascites or pericardial effusion requiring treatment 5)SVC syndrome 6)Symptomatic spinal cord compression 7)Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment 8)Have sn unhealed fracture 9)Have a serious concomitant active infection 10)Have any evidence of interstitial lung on chest X-ray 11)Have a serious unstable angina, congestive heart failure, arrythmia requiring treatment and a history of myocardial infarction within 12 months prior to enrollment. 12)Clinically significant drug allergy 13)History of use of pemetrexed or EGFR-TKI as preoperative or postoperative adjuvant therapy 14)Pregnant or beeast-feeding woman or patient who doesn't agree to contraception 15) Mental disease or psychotic manifestation 16)Not suitable for participating in the study for any other reason 17)Currently have or have a history of hemoptysis 18) Patients with or with anticipation of invasive procedures as defined below: 1.Major surgery within four weeks of registration 2.two weeks after drainage tube removal 3.two weeks after pleurodesis 4.Minor surgical procedures or core biopsy within two weeks of registration etc. 19)Have a bleeding tendency 20)Have an intestinal diverticulitis 21)Have a history of gastrointestinal perforation less than one year prior to enrollment 22)Uncontrolable hypertension 23)Have a evidence of thrombosis 24)HBs antigen-positive cases Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, objective response rate, toxity, QOL,Exploratory purpose: using the next-generation sequencer, we examine the therapeutic effect over time and changes in circulating free DNA of EGFR gene mutations from plasma.