Metastatic NSCLCPhase 3NCT06159790
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 Phase 3 study testing GME751 and Keytruda-EU in people with Metastatic NSCLC, run by Sandoz at 62 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic NSCLC
- What is being tested?
- GME751 and Keytruda-EU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 62 sitesin 16 countries
- Study dates
- 29 Apr 2024to 16 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
62 sites in 16 countries.
62 sites in 16 countries
India10 sites
Sandoz Investigational Site 2
Ahmedabad
Sandoz Investigational Site
Ahmedabad
Sandoz Investigational Site
Bhubaneswar
Sandoz Investigational Site
Hyderabad
Sandoz Investigational Site 2
Mumbai
Sandoz Investigational Site
Mumbai
Sandoz Investigational Site
Nagpur
Sandoz Investigational Site
Nashik
Sandoz Investigational Site
New Delhi
Sandoz Investigational Site
Varanasi
Japan7 sites
Sandoz Investigational Site
Asahikawa
Sandoz Investigational Site
Funabashi
Sandoz Investigational Site
Hiroshima
Sandoz Investigational Site
Kanazawa
Sandoz Investigational Site
Niigata
Sandoz Investigational Site
Okayama
Sandoz Investigational Site
Sapporo
Malaysia7 sites
Sandoz Investigational Site
Johor Bahru
Sandoz Investigational Site
Kuala Lumpur
Sandoz Investigational Site
Kuantan
Sandoz Investigational Site
Kuching
Sandoz Investigational Site
Malacca
Sandoz Investigational Site
Petaling Jaya
Sandoz Investigational Site
Putrajaya
Turkey (Türkiye)7 sites
Sandoz Investigational Site
Adana
Sandoz Investigational Site
Bursa
Sandoz Investigational Site
Gaziantep
Sandoz Investigational Site
Istanbul
Sandoz Investigational Site
Malatya
Sandoz Investigational Site
Sakarya
Sandoz Investigational Site
Yüreğir
Brazil5 sites
Sandoz Investigational Site
Belo Horizonte
Sandoz Investigational Site
Fortaleza
Sandoz Investigational Site
Ipatinga
Sandoz Investigational Site
Porto Alegre
Sandoz Investigational Site
São José do Rio Preto
Spain4 sites
Sandoz Investigational Site
A Coruña
Sandoz Investigational Site
Córdoba
Sandoz Investigational Site
Madrid
Sandoz Investigational Site
Oviedo
Taiwan4 sites
Sandoz Investigational Site
Douliu
Sandoz Investigational Site
Kaohsiung City
Sandoz Investigational Site
Taichung
Sandoz Investigational Site
Taipei
Bosnia and Herzegovina3 sites
Sandoz Investigational Site
Banja Luka
Sandoz Investigational Site
Sarajevo
Sandoz Investigational Site
Zenica
Philippines3 sites
Sandoz Investigational Site
Bacolod
Sandoz Investigational Site
Cebu City
Sandoz Investigational Site
Makati
Vietnam3 sites
Sandoz Investigational Site
Hà Nội
Sandoz Investigational Site
Hanoi
Sandoz Investigational Site
Ho Chi Minh City
Georgia2 sites
Sandoz Investigational Site
Batumi
Sandoz Investigational Site
Tbilisi
Romania2 sites
Sandoz Investigational Site
Cluj-Napoca
Sandoz Investigational Site
Floreşti
Thailand2 sites
Sandoz Investigational Site
Bangkok
Sandoz Investigational Site
Khon Kaen
United States1 site
Sandoz Investigational Site
Fountain Valley, California, 92708
About this study
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)
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.
Read the detailed 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.
- Conditions
- Metastatic NSCLC
- Being tested
- GME751, Keytruda-EU
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GME751Drug
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-EUDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| GME751 + pemetrexed + carboplatin or cisplatin | Experimental | Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. Receives: Drug: GME751 |
| Keytruda-EU + pemetrexed + carboplatin or cisplatin | Active comparator | Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. Receives: Drug: Keytruda-EU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 9 months from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start29 Apr 2024
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159790
- Sponsor's protocol ID
- CGME751A12301
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06159790
- Acronym / sponsor ID
- CGME751A12301
- Conditions
- Metastatic NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GME751 + pemetrexed + carboplatin or cisplatin | Experimental | Drug: GME751Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| Keytruda-EU + pemetrexed + carboplatin or cisplatin | Active comparator | Drug: Keytruda-EUParticipants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GME751Drug: 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) | Drug | GME751 + pemetrexed + carboplatin or cisplatin |
| Keytruda-EUDrug: 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) | Drug | Keytruda-EU + pemetrexed + carboplatin or cisplatin |
Primary outcome
Best Overall Response (BOR)
Time frame: up to 9 months from date of randomization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GME751 and Keytruda-EU in people with Metastatic NSCLC, run by Sandoz at 62 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in India, Japan, Malaysia, Turkey (Türkiye), Brazil and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response (BOR) (time frame: up to 9 months from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.