Advanced non-squamous non-small cell lung cancer
Conditions
Interventions
Erlotinib + Bevacizumab
Erlotinib
Sponsors
North East Japan Study Group (NEJSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically or cytologically documented non-squamous NSCLC (2)EGFR (Exon 19 deletion or Exon 21 L858R) mutation status, detected with PCR, is active (3)Stage IIIB or stage IV or recurrent NSCLC (4)No prior systemic chemotherapy. Patients with history of treatment with anticancer drugs for pleurodesis are not eligible. If patients have received neoadjuvant / adjuvant chemotherapy, the patients who experience recurrence after 6 months are permitted (5)Regarding the patients who have be treated with radiotherapy; 1)Not have received radiotherapy to lesions of lung 2)More than 2 weeks after receiving radiotherapy to lesions except lung (6)Regarding the patients who have be treated with therapy as follows; 1)More than 4 weeks after the last operation 2)More than 2 weeks after the last pleurodesis except anticancer drugs 3)More than 2 weeks after the last biopsy with an incision 4)More than 2 weeks after the last treatment for injury 5)More than 2 weeks after the last systemic administration of steroid over 4 weeks 6)More than 4 weeks after the last administration of other investigational drugs (7)Patients who have at least one or more measurable lesion by RESIST (Version1.1) (8)Aged >=20, at the time of consent (9)ECOG PS 0-2 (10)Have adequate organ function as follows; 1)neutrophil >=1,500/mm3 2)hemoglobin >=9.0g/dL 3)platelet >=100,000/mm3 4)bilirubin <=1.5mg/dL 5)AST/ALT <=2.5xULN 6)serum creatinine <=1.5mg/dL 7)PaO2(room air) >=70Torr or SpO2 >=94% 8)APTT <=ULN 9)PT-INR <=1.5 10)urine protein under 1+ (11)Written informed consent (12)Estimated life expectancy at least 3 months
Exclusion criteria
Exclusion criteria: (1)Exon 20 T790M mutation status, detected with PCR, is active. Have received (2)Have symptomatic brain metastasis (3)Have a history of multiple malignancies within 5 years (4)History of pulmonary hemorrhage or hemoptysis as defined below; 1)Hemosputum continuing for more than 1 week within 1 year before enrollment. 2)Have had or require continuous oral administration of hemostat 3)Have had or require injectable administration of hemostat (5)Evidence of bleeding diathesis or hemoptysis (6)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging (7)Evidence of tumor invading segmental bronchus (8)Uncontrolled pleural, ascites effusion or cardiac effusion (9)Having a history or serious complications as bellows; 1)SVC syndrome complication 2)Spinal cord compression 3)Having a history of serious symptomatic cerebrovascular disease within 1 year before enrollment 4)Unrecovered fracture or severe injury 5)Have severe infection 6)Having a history or evidence of ILD complication on imaging or lung infection (except history of radiation pneumonitis in radiation area) 7)Have gastrointestinal dysfunction as follows; <1>Impossible to take drugs orally <2>Need intravenous feeding <3>Have malabsorption by surgery <4>Have active peptic ulcer 8)Have severe corneal disease complication 9)Have severe heart disease complication 10)Have diverticulitis 11)Have ever had a history of gastrointestinal perforation within 1 year prior to registration 12)Have severe neurological deficit or mental disorder 13)Have active hepatic disease (10)Surgery planned in trial period (11)Have a history of severe allergy of other monoclonal antibody drugs (12)Have a history of EGFR TKI or anti-angiogenesis drug administration (13)Pregnant or breast-feeding woman (14)Patients who have no will to contraception (15)Patients whose participation in the trial is judged to be inappropriate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, response rate, disease control rate, duration of response, safety, QOL | — |
Countries
Japan
Contacts
Public ContactTatsuro Fukuhara
Miyagi Cancer Center Department of Respiratory Medicine
Outcome results
None listed