NIPH Clinical Trials Search

JRCT ID: jRCT2041240020

Registered date:23/04/2024

A study to compare efficacy, safety, and immunogenicity of GME751 and EU-authorized Keytruda in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC)

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedUntreated metastatic non-squamous non-small cell lung cancer (NSCLC)
Date of first enrollment21/05/2024
Target sample size60
Countries of recruitmentBosnia and Herzegovina,Japan,Brazil,Japan,Germany,Japan,Spain,Japan,Georgia,Japan,India,Japan,Malaysia,Japan,Philippines,Japan,Romania,Japan,Serbia,Japan,Thailand,Japan,Turkey,Japan,Taiwan,Japan,United States,Japan,Viet Nam,Japan
Study typeInterventional
Intervention(s)i.v. infusion of GME751 (200 mg every 3weeks) or Keytruda-EU (200 mg every 3weeks) with background chemotherapy of pemetrexed + carboplatin or cisplatin.


Primary OutcomeThe primary endpoint is the Best overall response (BOR) of either Complete response (CR) or Partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 up to 9 months.
Secondary Outcome- Compare descriptively GME751 and Keytruda-EU in terms of progression free survival (PFS) at 52 weeks. - Compare descriptively GME751 and Keytruda-EU in terms of overall survival (OS) at 52 weeks. - Compare descriptively GME751 and Keytruda-EU for duration of response (DOR) in terms of PFS at 52 weeks. - Compare descriptively GME751 and Keytruda-EU in terms of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) at 52 weeks. - Compare descriptively Trough level (Ctrough) of GME751 and Keytruda-EU - Compare descriptively GME751 and Keytruda-EU in terms of development of binding and neutralizing anti-drug antibodies (ADAs) up to 52 weeks.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1. At least 18 years of age 2. Untreated metastatic NSCLC 3. Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements 4. Measurable disease according to RECIST 1.1 5. Adequate organ function 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Other protocol-defined inclusion criteria apply.
Exclude criteria1. Squamous cell or mixed histology in NSCLC 2. Previously reported severe hypersensitivity reaction to pembrolizumab, chemotherapy or their excipients 3. Active autoimmune disease that has required chronic systemic treatment in the past 2 years. 4. Received live vaccine <=30 days before the first study treatment 5. Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer. Other protocol-defined exclusion criteria apply.

Related Information


Public contact
Name Chikako Rosario
Address Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo Tokyo Japan 104-0033
Telephone +81-80-8929-3137
Affiliation Parexel International Inc.
Scientific contact
Name Claudia Strewe
Address Industriestr. 25, 83607, Holzkirchen, Germany Japan
Telephone 49-8024-908-0
Affiliation Hexal AG