A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L)

A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L) - A phase III study of Platinum doublet chemotherapy +/- Nivolumab in advanced non-small cell lung cancer (WJOG8615L)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021136

Enrollment

530

Registered

2016-02-22

Start date

2016-09-25

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

Lung Cancer

Interventions

Platinum doublet chemotherapy (cisplatin 75mg/m2, or carbploatin (AUC 6)+pemetrexed 500mg/m2, cisplatin 75mg/m2+gemcitabine 1000mg/m2, carboplatin (AUC 6)+paclitaxel 200mg/m2), 4 courses, every 3week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically proven, advanced NSCLC 2. Chemotherapy-naive 3. With evaluable lesion per RECIST ver 1.1 4. Tumor specimen can be submitted to evaluate PD-L1 IHC 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion criteria

Exclusion criteria: 1. Subjects with active, known or suspected autoimmune disease. 2. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 3. Subjects with interstitial lung disease 4. Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection

Design outcomes

Primary

Measure	Time frame
Overall survival and progression-free survival	—

Secondary

Measure	Time frame
Overall response rate, survival rate at two years, and 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