advanced EGFR mutation-positive non-squamous non-small cell lung cancer
Conditions
Interventions
erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment
Sponsors
Department of Thoracic Oncology Osaka Medical Center for Cardiovascular diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cytologically or histologically documented non-squamous non-small cell carcinoma of the lung 2) Harboring activating EGFR mutation (exon 19 deletion, and / or exon 21 L858R point mutation)or uncommon mutation (G719X or L861Q). 3) Have NSCLC with Stage IIIB, not candidate for curative radiotherapy, Stage IV or recurrence disease after surgery 4)No previous chemotherapy. If preoperative or postoperative adjuvant chemotherapy was done, it has passed more than six months from the last day of administration. 5)All of the following conditions is necessary if a patient has previously received radiation therapy. 1.Extra pulmonary fied 2.More than 12 weeks since prior radiotherapy to thoracic bones. 3.More than 2 weeks since prior radiotherapy to extra-thoracic sites. 6)If there is evaluable lesions or without measurable lesions. 7))>=20 and <=74 years of age. 8)ECOG performance status of 0 or 1. 9)Adequate organ function. 10)Written informed consent. 11)Expected survival of >= 3 months.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKazumi Nishino
Osaka Medical Center for Cardiovascular diseases Department of Thoracic Oncology
Outcome results
None listed