A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study

A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study - Nivolumab re-challenge therapy after VEGF inhibitor therapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030938

Enrollment

Registered

2018-01-24

Start date

2018-01-07

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 re-challenge therapy (3mg/kg, every 2 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Stage IIIB,stageIV without any indications for radiotherapy 3)Those who were benefit from anti PD-1 antibody therapy such as CR, PR, SD. 4)ECOG performance status 0-1 5)With one or more measurable disease (RECIST ver.1.1) 6)Aged 20<= 7)Adequate organ function 8)Less than two weeks interval after last VEGF inhibitor therapy 9)Written informed concent

Exclusion criteria

Exclusion criteria: 1)Symptomatic brain metastasis 2)Active infections diseases 3)Serious complications 4)Active concomitant cancers 5)Severe adverse events of Nivolumab 6)Pregnancy, breastfeeding or suspected of being pregnant 7)Those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Progression free survival Over all survival Adverse events Examination of the immunity	—

Countries

Japan

Contacts

Public ContactTakashi Kasai

Tochigi Cancer Center Department of Medical Oncology,

takasai@tochigi-cc.jp+81-28-658-5151

Outcome results

None listed

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