Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Carboplatin

Pemetrexed

Pembrolizumab

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.

Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.

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)

GME751

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)

Keytruda-EU

Clinical Disclosure Representative

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.

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.

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)

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

Sandoz

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Subjects will receive GME751 via intravenous (IV) infusion.

Subjects will receive Keytruda-EU via intravenous (IV) infusion.

Subjects will receive Keytruda-US via intravenous (IV) infusion.

400 mg Q6W, i.v. infusion, over 24 weeks period

Keytruda - EU

Keytruda - US

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab (Keytruda-EU). The maximum study duration for a participant will be approximately 28 weeks including screening.

Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons.

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

A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab

The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

The PK similarity (AUCtau_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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)	NCT06159790	Metastatic NSCL...	GME751 Keytruda-EU	18 Years -	Sandoz
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)	NCT06159790	Metastatic NSCL...	GME751 Keytruda-EU	18 Years -	Sandoz
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma	NCT06153238	Melanoma	GME751 Keytruda - EU Keytruda - US	18 Years -	Sandoz
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma	NCT06153238	Melanoma	GME751 Keytruda - EU Keytruda - US	18 Years -	Sandoz
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma	NCT06153238	Melanoma	GME751 Keytruda - EU Keytruda - US	18 Years -	Sandoz

Spots Global Cancer Trial Database for gme751

Every month we try and update this database with for gme751 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gme751

Every month we try and update this database with for gme751 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gme751 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.