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)

A randomized, double-blind, parallel-group study to compare efficacy, safety, and immunogenicity of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC) - Jimmy-Lung

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041240020

Enrollment

Registered

2024-04-23

Start date

2024-10-29

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

Untreated metastatic non-squamous non-small cell lung cancer (NSCLC)

Interventions

i.v. infusion of GME751 (200 mg every 3weeks) or Keytruda-EU (200 mg every 3weeks) with background chemotherapy of pemetrexed + carboplatin or cisplatin.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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.

Exclusion criteria

Exclusion criteria: 1. Squamous cell or mixed histology in NSCLC 2. Known history of hypersensitivity (grade >=3) 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.

Design outcomes

Primary

Measure	Time frame
The 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

Measure	Time frame
- 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) at 52 weeks. - Compare descriptively GME751 and Keytruda-EU in terms of treatment-emergent adverse events (TEAEs) and serious TEAEs 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.	—

Measure

Time frame

- 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) at 52 weeks. - Compare descriptively GME751 and Keytruda-EU in terms of treatment-emergent adverse events (TEAEs) and serious TEAEs 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.

—

Countries

Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Philippines, Romania, Serbia, Spain, Taiwan, Thailand, Turkey, United States, Viet Nam

Contacts

Public ContactChikako Rosario

Parexel International Inc.

Clinicaltrial-registration@parexel.com+81-80-8929-3137

Outcome results

None listed

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