PIT-3

JRCT ID: jRCTs031180404

Registered date:20/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary lung cancer
• Date of first enrollment: 01/08/2017
• Target sample size: 25
• Study type: Interventional
• Intervention(s): The surgical resection is performed after 8 weeks of oral administration of erlotinib (150mg/day).

Outcome(s)

• Primary Outcome: 2-year progression-free survival

Secondary Outcome

- 5-year progression-free survival
- 2-year and 5-year overall survival
- Completion rate of the protocol treatment
- Complete resection rate
- Radiological response rate
- Down staging rate
- Safety
- Pathological response (Ef)
- Tumor markers (CEA/CYFRA)
- SUVmax on FDG-PET scan

Key inclusion & exclusion criteria

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

Include criteria

(1) Histologically or cytologically proven EGFR mutated (Ex19 deletions or Ex21 L858R) non-small cell lung cancer diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
(2) Stage IIIA- pathologically proven N2 disease
(3) Without previously treatment for lung cancer
(4) Age >=20
(5) ECOG PS 0-1
(6) Expected FEV 1.0 > 800ml after lung resection, SpO2 (Room air) >93%
(7) Adequate organ function
(8) Written informed consent

Exclude criteria

(1) EGFR mutation T790M postive
(2) Interstitial pneumonia or pulmanary fibrosis detectable on chest CT scan
(3) Privious history of drug induced lung injury
(4) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(5) Aactive infection
(6) History of congestive heart failure, angina pectoris or myocardial infarction withinthe last 1 year.
(7) Unterated bone fracture or serious wound
(8) Severe diarrhea
(9) Current or previous (within the last 1 year) history of GI perforation or diverticultis
(10) Ireus
(11) Severe drug allergy
(12) Investigational new drug or the unapproved drug is administered
(13) History of active double cancer
(14) History of pregnancy or lactation
(15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Related Information

• Primary Sponsor: Suzuki Kenji
• Secondary ID(s): UMIN000026197