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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)

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) (Jimmy-Lung)

Strewe Claudia

Hexal AG

Industriestr. 25, 83607, Holzkirchen, Germany

sandoz.disclosure@sandoz.com

Rosario Chikako

Parexel International Inc.

Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo

+81-80-8929-3137

Clinicaltrial-registration@parexel.com

Not Recruiting

May. 21, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

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.

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.

Both

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

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

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.

- 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.

+81-53-453-7111

April. 18, 2024

No

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