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)
Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and Keytruda in NSCLC
Plain English Summary
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) is a Phase 3 clinical trial sponsored by Sandoz studying Metastatic NSCLC. Tests if GME751 (a proposed pembrolizumab biosimilar) works as well as Keytruda in treating non-squamous NSCLC. For adults with untreated metastatic non-squamous NSCLC, without specific genetic mutations. Participation involves receiving infusions every 3 weeks and regular check-ups. Alternative treatments include other immunotherapy drugs like Keytruda. The trial aims to enroll 218 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if at least 18 years old, has non-squamous NSCLC, and no specific genetic mutations. Not eligible if has squamous cell NSCLC, hypersensitivity to pembrolizumab, or active autoimmune disease. Ages: 18 and older Health: No specific genetic mutations, adequate organ function, and ECOG performance status score of 0 or 1. This trial is studying Metastatic NSCLC, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the best overall response, which means how well the treatment works to shrink or control the cancer. The specific primary outcome measures are: Best Overall Response (BOR) (up to 9 months from date of randomization). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial fills a gap by comparing a biosimilar to the EU-authorized Keytruda, providing a potential cost-effective alternative for treating non-squamous NSCLC. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Metastatic NSCLC, where improved treatment options are needed.
Investor Insight
Market size is significant, with a large patient population for NSCLC, and this trial could impact the competitive landscape by offering a biosimilar option. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you have any specific genetic mutations or autoimmune diseases. Participation involves regular infusions and check-ups every 3 weeks. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 218 participants
Interventions
- 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)
- DRUG: 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)
Primary Outcomes
- Best Overall Response (BOR) (up to 9 months from date of randomization)
Full Eligibility Criteria
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.
Trial Locations
- Sandoz Investigational Site, Fountain Valley, California, United States
- Sandoz Investigational Site, Banja Luka, Bosnia and Herzegovina
- Sandoz Investigational Site, Sarajevo, Bosnia and Herzegovina
- Sandoz Investigational Site, Zenica, Bosnia and Herzegovina
- Sandoz Investigational Site, Belo Horizonte, Brazil
- Sandoz Investigational Site, Fortaleza, Brazil
- Sandoz Investigational Site, Ipatinga, Brazil
- Sandoz Investigational Site, Porto Alegre, Brazil
- Sandoz Investigational Site, São José do Rio Preto, Brazil
- Sandoz Investigational Site, Batumi, Georgia
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06159790?
NCT06159790 is a Phase 3 INTERVENTIONAL study titled "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)." It is currently completed and is sponsored by Sandoz. The trial targets enrollment of 218 participants.
What conditions does NCT06159790 study?
This trial investigates treatments for Metastatic NSCLC. The primary condition under study is Metastatic NSCLC.
What treatments are being tested in NCT06159790?
The interventions being studied include: GME751 (DRUG), Keytruda-EU (DRUG). 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)
What does Phase 3 mean for NCT06159790?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06159790?
This trial is currently "Completed." It started on 2024-04-29. The estimated completion date is 2026-03-16.
Who is sponsoring NCT06159790?
NCT06159790 is sponsored by Sandoz. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06159790?
The trial aims to enroll 218 participants. The trial status is completed.
How is NCT06159790 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06159790?
The primary outcome measures are: Best Overall Response (BOR) (up to 9 months from date of randomization). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06159790 being conducted?
This trial is being conducted at 20 sites, including Fountain Valley, California; Banja Luka; Sarajevo; Zenica and 16 more sites (United States, Bosnia and Herzegovina, Brazil).
Where can I find official information about NCT06159790?
The official record for NCT06159790 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06159790. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06159790 testing in simple terms?
Tests if GME751 (a proposed pembrolizumab biosimilar) works as well as Keytruda in treating non-squamous NSCLC. For adults with untreated metastatic non-squamous NSCLC, without specific genetic mutations.
Why is this trial significant?
This trial fills a gap by comparing a biosimilar to the EU-authorized Keytruda, providing a potential cost-effective alternative for treating non-squamous NSCLC. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06159790?
Potential risks include side effects common to immunotherapy, such as fatigue, skin rash, and immune-related adverse events. Always report any new symptoms to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06159790?
Ask your doctor if you have any specific genetic mutations or autoimmune diseases. Participation involves regular infusions and check-ups every 3 weeks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06159790 signal from an investment perspective?
Market size is significant, with a large patient population for NSCLC, and this trial could impact the competitive landscape by offering a biosimilar option. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving infusions every 3 weeks and regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.