Yokohama City Respiratory Research Group; YCRG#18

JRCT ID: jRCTs031190077

Registered date:17/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung cancer
• Date of first enrollment: 24/12/2019
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Afatinib 150 mg/day plus bevacizumab 15 mg/kg every 3 weeks continues until discontinuation criteria are met.

Outcome(s)

• Primary Outcome: Objective Response Rate (ORR)
• Secondary Outcome: Progression free survival, Overall survival, Disease control rate, Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
2) Stage IIIB, IV or postoperative recurrence
3) Sensitive EGFR gene mutations
4) The disease is mesurable based on RECIST guidelines 1.1.
5)Loss of response or intolerance to previous therapy
6)More than 1 course of chemotherapy Including Osimertinib
7) Afatinib naive
8) Eligible for received adjuvant chemotherapy
9) Patients treated with radiotherapy can be registered if they met the following criteria; Target lesion is not involved in radation field, Palliative radiation exposure to chest bone lesions has been more than 12 weeks since the last exposure, Irradiation to other than the chest has been more than 2 weeks since the last irradiation date at the time of registration
10) At the time of registration, the following period has passed since the last treatment; Operation: 4 weeks or more, Continous chest drainage: 2 weeks or more, Pleuroadherence without antineoplastic agents: 2 weeks or more
11) ECOG PS; 0, 1, 2
12) Patients expected to survive for at least 3 months
13) Good organ function
WBC >=1500 per mm3, Neutrophils >= 1000 per mm3, Hb >= 8.0 g per dL without blood transfusion within 14 days before registration, PLT >= 10 times 104 per mm3, TBil <= 1.5 mg per dL, AST <= 100 U per L, ALT <= 100 U per L, Plasma Creatinine <= 1.5 mg per dL, SpO2 >= 93%
14) Written informed consent is obtained
15) Over 20 years old, Both male and female

Exclude criteria

1) Interstitial pneumonia or pulmonary fibrosis
2) Multiple cancer
3) Pleural effusion, ascites and pericardial effusion requiring drainage
4) Cases with the following serious complications; Uncontrolled angina, myocardial infarction, and heart failure within 3 months, Uncontrollable diabetes or hypertension, Uncontrollable protein urine, Severe infection, Severe diarrhea, Hemoptysis (over 2.5 ml of fresh blood), Other severe complications (eg ileus, superior vena cava syndrome, etc.)
5) Nursing or pregnant women.
6) the attending doctor judged as inappropriate

Related Information

• Primary Sponsor: Kobayashi Nobuaki