A phase I study; Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib

JRCT ID: jRCTs051180008

Registered date:08/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced non-small cell lung cancer
• Date of first enrollment: 02/05/2018
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Osimertinib 80mg
Afatinib
Level 1: 20mg
Level 2: 30mg
Level 3: 40mg

Outcome(s)

• Primary Outcome: To evaluate the dose-limiting toxicity and maximum targeted dose and to determine the recommended dose of afatinib in combination with osimertinib

Secondary Outcome

Objective response rate
Progression free survival
Overall survival
Analysis of response based on plasma EGFR gene mutation

Key inclusion & exclusion criteria

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

Include criteria

1)Non-small cell lung cancer proven by histology and/or cytology with EGFR active mutation
2)Stage IIIB, IIIC, IV or postoperative/post chmoradiation therapy recurrence
3)Prior Osimertinib failure
4)Patients who could treat with a 80mg dose of osimertinib
5)20 years or older
6)ECOG PS 0 or 1
7)Adequate organ function
8)At least one or more measurable lesion by RECIST
9)Written informed consent for translational research
10) Written informed consent

Exclude criteria

1) Patients who are difficult to treat enrolled doses due to toxicity of afatinib
2) History of drug-induced pneumonitis/Interstitial pneumonia
3) Symptomatic brain metastasis/ leptomeningitis
4) Bone metastasis to treat by operation or radiation therapy
5) Uncontrollable pleural, peritoneal or pericardial effusion
6) Prior thoracic palliative radiotherapy within 2wks
7) SCLC transformation
8) History of active double cancer
9) Severe infection
10) Active HBV infection
11) No intention to birth control
12) Unstable psychic disorder
13) Under treatment of steroid therapy or immunosuppressive therapy
14) History of allergic reaction
15) Patients who treated with PD-1 or PD-L1 inhibitors within six months
16) Decision of ineligibility by a physician

Related Information

• Primary Sponsor: Tanaka Hiroshi
• Secondary Sponsor: Miura Satoru,Nippon boehringer ingelheim
• Secondary ID(s): UMIN000031501