A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.

A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer. - Personalized Induction Therapy Clinical Trial-3 (PIT-3)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026197

Enrollment

Registered

2017-02-17

Start date

2017-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IIIA-N2 EGFR mutated, Non-small cell lung cancer

Interventions

The surgical resection is performed after 8 weeks of oral administration of erlotinib (150mg/day).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 (7) Adequate organ function (8) Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKazuya Takamochi

Juntendo University Thoracic Surgery

ktakamo@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026