A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L)

A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L) - Nivolumab re-challenge study (WJOG9616L)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028561

Enrollment

Registered

2017-08-08

Start date

2017-10-17

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

Pre-treated lung cancer

Interventions

Nivolumab 240mg/body, every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically proven NSCLC 2. Clinical stage IIIB, C, IV, or post-operative relapse based on the classification of Lung Cancer ver8 3. Without symptomatic brain metastasis 4. With targetable lesion based on RECIST ver1.1 5. Those who were benefit from PD-1/L1 monotherapy such as CR, PR, SD lasting more than 6 months 6. ECOG PS of 0-1

Exclusion criteria

Exclusion criteria: 1. Prior history of serious immune related adverse event 2. With active auto-immune disease 3. With interstitial lung disease confirmed by chest CT 4. Those receive steroid therapy more than prednisolone more than 10mg/day

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of nivolumab in NSCLC patients those who were benefit from prior PD-1/L1 inhibitors.	—

Secondary

Measure	Time frame
Disease control rate, progression-free survival, overall survival, safety	—

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