A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer.

A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer. - A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer. (PRINCIPAL study,HANSHIN 0116)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023646

Enrollment

Registered

2016-08-16

Start date

2016-05-01

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

Interventions

Nivolumab administered initially at 3 mg/kg by vein every 2 weeks Palliative radiation therapy performed within 10days after first administration of Nivolumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Over 20 years old 2.Histologically or cytologically proven non-small cell lung cancer (except LCNEC) 3. Stage IIIB, stage IV or recurrent disease after surgery 4. Previously treated with systemic chemotherapy. 4-1 EGFR/ALK negative or unknown patient must receive previously platinum doublet chemotherapy. (over 75years old, monotherapy is allowed) 4-2 EGFR or ALK positive patient must previously receive both olatinum doublet chemotherapy and molecular targeted drug. 5. Patients suitable for palliative radiation therapy 6. ECOG PS 0-2 7.Patients are expected to live over 90days 8. SpO2>=92 or PaO2 >=60mmHg 9. adequate organ function 10. Patients with or without brain metastasis are eligible. 11. Do not need for steroid 12. more than 14 days of interval after pretreatment. 13.Written informed consent

Exclusion criteria

Exclusion criteria: 1.History of severe drug allergy 2.Side effects of previously treatment is existed and disturb safety analysis 3.urrent or previous History of auto immune disease 4.Pulmonary fibrosis detected by chest CT or clinical examination 5.current or previous history of diverticulitis or ulcerative disease of GI 6.History of active double cancer with in 5 years 7.History of pericardial effusion/ pleural effusion/ ascites with treatment needed. 8.Brain metastasis required for radiation therapy. 9.uncontrolled pain due to bone metastasis 10.Current or previous (within the last 180days) history of symptomatic cerebrovascular disease or thromboembolism. 11.Uncontrollable severe cardiovascular disease 12.Uncontrollable diabetes mellitus 13. previous (within the last 14 days) pleurodesis 14.previous (within the last 28 days) operation with systemic anesthesia 15.previous (within the last 56 days) thoracic radiation therapy with over 40Gy. 16.systemic infectious disease require treatment. 17.Active hepatitis type B or typeC 18.Sever side effect caused by previously treated immune checkpoint blockade. 19.History of active psychological disease. 20.History of dementia 21.Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Design outcomes

Primary

Measure	Time frame
Response rate(extra field of radiation therapy)	—

Secondary

Measure	Time frame
Overall survival, Progression free survival , disease control rate, Toxicity,	—

Countries

Japan

Contacts

Public ContactYoshiko Urata

Hyogo Cancer Center Thoracic Oncology

urata@hp.pref.hyogo.jp0789-929-1151

Outcome results

None listed

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