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)

Metastatic NSCLC Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159790
• Other study ID #: CGME751A12301
• Status: Recruiting
• Phase: Phase 3
• Start date: April 29, 2024
• Est. completion date: August 28, 2026

Study information

• Verified date: March 2024
• Source: Sandoz
• Contact: Clinical Disclosure Representative
• Phone: +49 8024 / 908 0
• Email: sandoz.disclosure[@]sandoz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.

Description:

Eligible participants will be randomized in a 1:1 ratio to receive either GME751, or European Union (EU)-authorized pembrolizumab (Keytruda-EU) in combination with chemotherapy. The maximum study duration for a participant will be approximately 56 weeks including screening.

Treatment duration is 52 weeks (17 treatment cycles of study treatment GME751 or Keytruda-EU in combination with chemotherapy, each cycle with a duration of 3 weeks).

Participants will discontinue study participation in case of disease progression, unacceptable toxicity or other reasons.

Participants who are benefiting from treatment with pembrolizumab without signs of progression or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: August 28, 2026
• Est. primary completion date: August 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Untreated metastatic NSCLC

• Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements

• Measurable disease according to RECIST 1.1

• Adequate organ function

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Squamous cell or mixed histology in NSCLC

• Known history of hypersensitivity (grade =3) to pembrolizumab, chemotherapy or their excipients

• Active autoimmune disease that has required chronic systemic treatment in the past 2 years.

• Received live vaccine =30 days before the first study treatment

• 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 inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Metastatic NSCLC

Intervention

Drug:
• GME751
Drug: GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion)
• Keytruda-EU
Drug: Keytruda-EU Concentrate for solution for infusion, biologic, liquid in vial, 100 mg, 200mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion)

Locations

Country	Name	City	State
Georgia	Sandoz Investigational Site	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response (BOR)	Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) up to 9 months according to RECIST 1.1 as assessed by Blinded Central Imaging	up to 9 months from date of randomization