A randomized phase II study comparing nivolumab with the combination of carboplatin and pemetrexed for epidermal growth factor receptor (EGFR) mutants non-squamous non-small cell lung cancer acquired resistance to EGFR-tyrosine kinase inhibitor from causes other than T790M.(WJOG8515L)

A randomized phase II study comparing nivolumab with the combination of carboplatin and pemetrexed for epidermal growth factor receptor (EGFR) mutants non-squamous non-small cell lung cancer acquired resistance to EGFR-tyrosine kinase inhibitor from causes other than T790M.(WJOG8515L) - A randomized phase II study comparing nivolumab with the combination of CBDCA and PEM for EGFR mutants NSCLC acquired resistance to EGFR-TKI from causes other than T790M.(WJOG8515L)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021133

Enrollment

100

Registered

2016-02-22

Start date

2016-04-12

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

biweekly 3mg/kg nivolumab treatment Combination treatment with carboplatin (AUC = 6, *if the case over 75 years, AUC=5) + pemetrexed (500mg/m2) following with maintenance therapy with pemetrexed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects with histologically confirmed Stage IV or recurrent NSCLC with disease progression on therapy with more than 1 prior EGFR TKI therapy. 2) Evidence of A , B or C A. Proven T790M negative in tissue samples by re-biopsy after prior EGFR-TKI treatment. B. After proven T790M positive in tissue or plasma samples by re-biopsy after prior EGFR-TKI, showing disease recurrence or progression for administration of third generation EGFR-TKI. C. Progression after third generation EGFR-TKI as an initial therapy. 3) Subjects with confirmed EGFR mutations (ie, G719X, L861Q, S768I, Del 19, and L858R) 4) Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 5) Men and women above 20

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) Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 4) Subjects with interstitial lung disease 5) Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival, Overall response rate, Duration of response, Rate of adverse events, Overall survival and progression free survival for PD-L1 status	—

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