Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)

Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) - Perioperative pirfenidone for lung cancer with fibrosis evaluation (PEOPLE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007774

Enrollment

Registered

2012-04-16

Start date

2012-06-01

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

non-small-cell lung cancer combined with idiopathic pulmonary fibrosis

Interventions

Oral administration of pirfenidone starting from 4-6 weeks before the surgery.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20y.o. <= age <= 75y.o. 2)Cytological, histological, or roentgenological diagnosis of non-small-cell lung cancer 3) UIP pattern or possible UIP pattern of "high-resolution computed tomography criteria for UIP pattern" published by ATS/ERS/JRS/ALAT in 2011. 4) Tolerability for the general anesthesia. 5) Resectable cancer lesion by surgery less than single lobectomy 6) Predicted post-surgical FEV1.0 >=1000ml 7)Possibility of oral administration of the drugs 8)Performance Status (ECOG Scale):0 or 1 9)Written informed consent before registration

Exclusion criteria

Exclusion criteria: 1)History of thoracotomy or video-assisted thoracoscopic surgery (We accept the patients who have the history of surgical biopsy for diagnosing IPF more than 6 months ago.) 2) Treatment history of IPF (e.g., pirfenidone, steroid, erythromycin, and immunosuppressors) before registration. When these drugs which can become the treatment of IPF were used even if for other diseases, we exclude this case. 3) History of radiation therapy (which include a lung in the treatment field) or chemotherapy. 4) Other known causes of interstitial pneumonia (e.g., environmental exposures, connective tissue disease, and drug toxicity). 5) Induced oxygen therapy 6) Local or systemic active infection which requires treatment. 7) Severe complications (e.g., bleeding from digestive organs, heart diseases, glaucoma, and diabetes). 8) History of severe hypersensitivity. 9) Mental diseases which prevent from registration of this trial. 10) Pregnant ladies, nursing ladies, the ladies with possibility of pregnancy, or the ladies who does not have intention to prevent pregnancy. 11) Obvious history of acute exacerbation of IPF. 12) Judged as inappropriate for this trial by the medical attendant by other reasons.

Design outcomes

Primary

Measure	Time frame
Non-incidence of acute exacerbation of IPF within 30 days after the surgery	—

Secondary

Measure	Time frame
Safety : complications due to pirfenidone (e.g., digestive organ toxicity and photo-allergy) and other general complications after surgery	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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