A phase I study; Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
- Conditions
- Advanced non-small cell lung cancer
- Registration Number
- JPRN-jRCTs051180008
- Lead Sponsor
- Tanaka Hiroshi
- Brief Summary
Bombination therapy with OSI and AFA is tolerable for OSI-resistant EGFR-mutated NSCLC. However, the additional effect of AFA on OSI may be limited in OSI-resistant settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 13
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method