CheckMate 227, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 227

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223011

Enrollment

2220

Registered

2015-11-11

Start date

2015-11-05

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

investigational material(s) Generic name etc : Nivolumab INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1 Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

Exclusion criteria

Exclusion criteria: Subjects with untreated Central nervous system (CNS) metastases are excluded Subjects with an active, known or suspected autoimmune disease are excluded Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

Design outcomes

Primary

Measure	Time frame
efficacy Overall survival (OS) [ Time Frame: approximately 48 months ] Progression-free Survival (PFS) as determined by blinded independent central review (BICR) [ Time Frame: approximately 40 months ]	—

Secondary

Measure	Time frame
efficacy Objective response rate (ORR) [ Time Frame: Up to 48 months ] ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: Up to 48 months ] Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment	—

Measure

Time frame

efficacy Objective response rate (ORR) [ Time Frame: Up to 48 months ] ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: Up to 48 months ] Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment

—

Countries

Africa, Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

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