Non Small Cell Lung Cancer MetastaticPhase 3NCT05668650
Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC
A Phase 3 study testing Pembrolizumab and Pembrolizumab biosimilar in people with Non Small Cell Lung Cancer Metastatic, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial summary
This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic
- What is being tested?
- Pembrolizumab and Pembrolizumab biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Aug 2023to Dec 2024
- 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
- Individuals must meet all of the following criteria to be included in the study:
- Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
- Greater than or equal to 18 years of age at the time of signing the ICF.
- Body weight ≥50 kg at Screening.
- Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for the disease. For those subjects in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
- At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.
Show all 19Show fewer
- Programmed death-ligand 1 (PD-L1) expression ≥50%, locally determined by immunohistochemistry, as determined by a Food and Drug Administration (FDA) validated method.
- Life expectancy of at least 3 months.
- ECOG performance status of 0 to 1.
- Adequate hepatic, renal, hematologic, endocrine, and coagulation function, defined as:
- Liver function: bilirubin level ≤1.5 × the upper limit of normal (ULN) (≤3 × ULN for subjects with Gilbert's syndrome), albumin level ≥ lower limit of normal (LLN), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 × ULN in subjects without liver metastases or ≤5 × ULN in subjects with liver metastases.
- Renal function: serum creatinine level ≤1.5 × ULN, calculated creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
- Hematologic function: absolute neutrophil count ≥1.5 × 109/L; platelet count ≥100 × 109/L, hemoglobin ≥9 g/dL.
- Endocrine function: thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.
- Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic range for the 14 days before the first dose of the study drug.
- Subjects with a negative COVID-19 test (done at the discretion of investigator or per local regulation) within previous 24 hours before randomization. In case of confirmed COVID-19 infection before Screening, documentation of resolution of infection by appropriate laboratory test is required.
- No history of prior malignancy, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ, or has undergone potentially curative therapy without evidence of disease recurrence for 3 years from the start of that therapy.
- Women of childbearing potential (WOCBP) must either abstain from sexual intercourse or employ highly effective contraception measures during the study and for at least 6 months after the last dose of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range for women under 50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 6 months after the last dose of the study drug.
- Male subjects, if not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 6 months after the last dose of the study drug. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above mentioned duration.
Who cannot join
- Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
- Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization, whichever is longer.
- Known actionable mutations for which there is an approved and available therapy.
- Known central nervous system metastases and/or carcinomatous meningitis.
- Previous systemic steroid therapy (prednisone at a dose of 10 mg or equivalent) within 3 days before the first dose of the study drug or receiving any other form of immunosuppressive medication. Subjects receiving daily steroid replacement therapy (daily prednisone at a dose of 5 to 7.5 mg or equivalent) could be included in the study.
Show all 21Show fewer
- Subject who requires any other form of localized or systemic antineoplastic therapy during the study.
- Prior anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, anti programmed death-ligand 2 (anti-PD-L2), anti-CD137, or anti cytotoxic T lymphocyte antigen (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co stimulation of T cells or immune checkpoints).
- Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks before the first dose of the study drug; have received thoracic radiation therapy of >30 gray (Gy) within 6 months before the first dose of the study drug. Palliative radiotherapy is allowed if completed >14 days before the first dose of the study drug.
- Known history of severe hypersensitivity to another monoclonal antibody.
- Active autoimmune disease which has required systemic treatment in the last 2 years before the first dose of the study drug (eg, disease modifying agents, corticosteroids, or immunosuppressive treatment). Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency) is not considered a form of systemic treatment.
- Interstitial lung disease or pneumonitis requiring oral or intravenous steroids.
- Active infection or a previous infection requiring intravenous systemic treatment within 30 days before the first dose of the study drug.
- Subject who has received or is about to receive a live virus vaccination within 30 days before the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Known history of human immunodeficiency virus (HIV)-1 or HIV-2.
- Known active tuberculosis or hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C (hepatitis C antibody positive and hepatitis C virus [HCV] RNA positive).
- Subject who has received a solid organ/tissue allogeneic transplant.
- Known psychiatric disorders that could interfere with cooperation with study requirements.
- At the time of signing the ICF, the subject is a regular user (including "recreational use") of any illicit drug or has a recent history (within the past year) of substance abuse (including alcohol).
- Subject is pregnant or lactating or expecting to conceive during the study or up to 120 days after the last dose of the study drug.
- Immediate family member who is at the research site or sponsoring staff who is directly involved in this study
Trial locations and contacts
1 site in 1 country.
Marcelo Tinelli, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Clínica Viedma
Viedma, Río Negro Province, 5300
Marcelo Guthmann, PhD, marcelo.guthmann@elea.com
About this study
Official title: Randomized, Multicenter, Multinational, Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV NSCLC
This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled.
Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent.
Read more
The study will consist of 2 periods defined as follows:
- Main Study Period from Screening up to Cycle 6 included.
- Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first.
A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
Read the detailed description
MB12 is being developed by mAbxience Research S.L., and its clinical development is sponsored by Laboratorio Elea Phoenix S.A. as a proposed biosimilar to Keytruda®. The reference medicinal product is European Union (EU)-sourced Keytruda®, manufactured and marketed by Merck Sharp \& Dohme.
Study drugs: MB12 and Keytruda® Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks
The study will consist of 2 periods defined as follows:
- Main Study Period from Screening up to Cycle 6 included.
- Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (CR, PR, and SD). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first.
The anti-tumor activity will be determined by local radiological examination for all measurable and evaluable lesions according to RECIST version 1.1. During the Main Study Period, the efficacy assessments will be performed every 6 weeks from the first infusion (Cycle 1, Day 1). During the Extended Treatment Period, the assessments will be performed every 9 weeks, from Week 18 onwards, according to RECIST criteria, until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to 52 weeks, whichever occurs first.
Safety assessments include vital signs, physical examination, ECOG performance status, 12-lead ECGs, clinical laboratory assessments (hematology, clinical chemistry, thyroid function, coagulation, virology, urinalysis, and pregnancy tests), and AE assessments.
The primary PK parameter is AUCss at Cycle 6. Serum concentrations used for estimating AUCss will be determined by a validated analytical procedure once steady state (5 elimination half-lives) has been reached.
Secondary PK parameters, including maximum concentration (Cmax), minimum concentration (Ctrough), time to maximum concentration (tmax), clearance (CL), elimination half-life (t1/2), and volume of distribution (Vss), will be calculated for Cycle 1 and Cycle 6, as applicable. Additional PK parameters may be included if deemed appropriate.
PK variables will be calculated according to the recommendations of the European Medicines Agency (EMA) and the World Health Organization (WHO).
Blood samples for PK analysis will be collected at Cycle 1 and Cycle 6 as follows: predose; at 30 minutes after the SOI; at 4, 6, 24, 48, 168, 336, and 504 hours after the SOI.
The comparison of the immunogenicity profile of MB12 versus Keytruda® during the Main Study and Extended Treatment Periods include:
- ADAs
- Nabs in ADA (+) samples
- Titers in ADA (+) samples During the Main Study Period, blood samples for immunogenicity will be collected pre-dose at Cycle 1 Day 1, Cycle 1 Day 14, pre-dose at Cycle 3 Day 1, and pre-dose at Cycle 6 Day 1. During the Extended Treatment Period, 2 additional samples will be collected in those subjects who continue treatment after Cycle 6 at Week 26 and at Week 52 or EOT/early termination (if this occurs before Week 52 and if previous sample has not been taken within the last 16 weeks).
- Conditions
- Non Small Cell Lung Cancer Metastatic
- Being tested
- Pembrolizumab, Pembrolizumab biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes).
Pembrolizumab biosimilarDrug
Also called MB12
Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Medical Reference Product | Active comparator | Keytruda® will be administered as monotherapy, on Day 1 of every 3-week cycle (21 days), during the Main Study Period (6 cycles) unless there is disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first.
Those subjects with clinical benefit from treatment (CR, PR, and SD) as per the investigator's discretion, will be allowed to continue receiving treatment with MB12/Keytruda® in the Extended Study Period, according to the arm initially assigned, every 3 weeks, for a maximum of 52 weeks from the first infusion or until evidence of disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first. Receives: Drug: Pembrolizumab |
| Investigational Product | Experimental | MB12 will be administered as monotherapy, on Day 1 of every 3-week cycle (21 days), during the Main Study Period (6 cycles) unless there is disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first.
Those subjects with clinical benefit from treatment (CR, PR, and SD) as per the investigator's discretion, will be allowed to continue receiving treatment with MB12/Keytruda® in the Extended Study Period, according to the arm initially assigned, every 3 weeks, for a maximum of 52 weeks from the first infusion or until evidence of disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first. Receives: Drug: Pembrolizumab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve)
The primary PK parameter is AUC (area under the curve in the serum concentration-time plot) at Cycle 6. Serum concentrations used for estimating AUC will be determined by a validated analytical procedure once steady state (5 elimination half-lives) has been reached.
Measured: Four months
Cmax (maximum serum concentration)
Cmax will be calculated for Cycle 1 and Cycle 6.
Measured: Four months
Tmax (time for maximum serum concentration)
Tmax will be calculated for Cycle 1 and Cycle 6.
Measured: Four months
Secondary outcomes (3)
Best overall response
To compare the best overall response (BOR) during the Main Study Period and progression-free survival (PFS) during the Extended Treatment Period of MB12 and Keytruda®.
Measured: 52 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.
Measured: 52 weeks
Number of participants developing anti-drug antibodies
Blood samples will be taken to determine ADAs through 52 weeks after the first study drug administration. Anti pembrolizumab antibodies will be presented as negative (lower than the test cut-off) or positive (above the test cut-off) and will be presented by treatment group.
Results will be presented by summarizing frequency (n) and percentage (%) of subjects with a positive result.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start15 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer MetastaticStudies 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
- Model description
- This is a randomized, multicenter, multinational, double-blind, and parallel-group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Eduardo Spitzer, MSc, Study chair, Laboratorio Elea Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668650
- Sponsor's protocol ID
- MB12-C-01-22
- Status last verified
- Jul 2024
- First submitted
- 12 Dec 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Multinational, Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV NSCLC
- ClinicalTrials.gov ID
- NCT05668650
- Acronym / sponsor ID
- MB12-C-01-22
- Conditions
- Non Small Cell Lung Cancer Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Dec 2022 (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.
This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled.
Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent.
The study will consist of 2 periods defined as follows:
- Main Study Period from Screening up to Cycle 6 included.
- Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first.
A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
Detailed description
MB12 is being developed by mAbxience Research S.L., and its clinical development is sponsored by Laboratorio Elea Phoenix S.A. as a proposed biosimilar to Keytruda®. The reference medicinal product is European Union (EU)-sourced Keytruda®, manufactured and marketed by Merck Sharp \& Dohme.
Study drugs: MB12 and Keytruda® Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks
The study will consist of 2 periods defined as follows:
- Main Study Period from Screening up to Cycle 6 included.
- Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (CR, PR, and SD). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first.
The anti-tumor activity will be determined by local radiological examination for all measurable and evaluable lesions according to RECIST version 1.1. During the Main Study Period, the efficacy assessments will be performed every 6 weeks from the first infusion (Cycle 1, Day 1). During the Extended Treatment Period, the assessments will be performed every 9 weeks, from Week 18 onwards, according to RECIST criteria, until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to 52 weeks, whichever occurs first.
Safety assessments include vital signs, physical examination, ECOG performance status, 12-lead ECGs, clinical laboratory assessments (hematology, clinical chemistry, thyroid function, coagulation, virology, urinalysis, and pregnancy tests), and AE assessments.
The primary PK parameter is AUCss at Cycle 6. Serum concentrations used for estimating AUCss will be determined by a validated analytical procedure once steady state (5 elimination half-lives) has been reached.
Secondary PK parameters, including maximum concentration (Cmax), minimum concentration (Ctrough), time to maximum concentration (tmax), clearance (CL), elimination half-life (t1/2), and volume of distribution (Vss), will be calculated for Cycle 1 and Cycle 6, as applicable. Additional PK parameters may be included if deemed appropriate.
PK variables will be calculated according to the recommendations of the European Medicines Agency (EMA) and the World Health Organization (WHO).
Blood samples for PK analysis will be collected at Cycle 1 and Cycle 6 as follows: predose; at 30 minutes after the SOI; at 4, 6, 24, 48, 168, 336, and 504 hours after the SOI.
The comparison of the immunogenicity profile of MB12 versus Keytruda® during the Main Study and Extended Treatment Periods include:
- ADAs
- Nabs in ADA (+) samples
- Titers in ADA (+) samples During the Main Study Period, blood samples for immunogenicity will be collected pre-dose at Cycle 1 Day 1, Cycle 1 Day 14, pre-dose at Cycle 3 Day 1, and pre-dose at Cycle 6 Day 1. During the Extended Treatment Period, 2 additional samples will be collected in those subjects who continue treatment after Cycle 6 at Week 26 and at Week 52 or EOT/early termination (if this occurs before Week 52 and if previous sample has not been taken within the last 16 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, multicenter, multinational, double-blind, and parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Medical Reference Product | Active comparator | Drug: PembrolizumabKeytruda® will be administered as monotherapy, on Day 1 of every 3-week cycle (21 days), during the Main Study Period (6 cycles) unless there is disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first. Those subjects with clinical benefit from treatment (CR, PR, and SD) as per the investigator's discretion, will be allowed to continue receiving treatment with MB12/Keytruda® in the Extended Study Period, according to the arm initially assigned, every 3 weeks, for a maximum of 52 weeks from the first infusion or until evidence of disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first. |
| Investigational Product | Experimental | Drug: Pembrolizumab biosimilarMB12 will be administered as monotherapy, on Day 1 of every 3-week cycle (21 days), during the Main Study Period (6 cycles) unless there is disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first. Those subjects with clinical benefit from treatment (CR, PR, and SD) as per the investigator's discretion, will be allowed to continue receiving treatment with MB12/Keytruda® in the Extended Study Period, according to the arm initially assigned, every 3 weeks, for a maximum of 52 weeks from the first infusion or until evidence of disease progression, intolerance to the study drug, or treatment discontinuation for other reason, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
- Greater than or equal to 18 years of age at the time of signing the ICF.
- Body weight ≥50 kg at Screening.
- Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for the disease. For those subjects in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
- At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.
Key exclusion criteria (21 listed)
- Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
- Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization, whichever is longer.
- Known actionable mutations for which there is an approved and available therapy.
- Known central nervous system metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaStudy drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes). | Drug | Medical Reference Product |
| Pembrolizumab biosimilarAlso: MB12Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes). | Drug | Investigational Product |
Primary outcome
AUC (area under the curve)
Time frame: Four months
The primary PK parameter is AUC (area under the curve in the serum concentration-time plot) at Cycle 6. Serum concentrations used for estimating AUC will be determined by a validated analytical procedure once steady state (5 elimination half-lives) has been reached.
Cmax (maximum serum concentration)
Time frame: Four months
Cmax will be calculated for Cycle 1 and Cycle 6.
Tmax (time for maximum serum concentration)
Time frame: Four months
Tmax will be calculated for Cycle 1 and Cycle 6.
3 secondary outcomes
Best overall response
Time frame: 52 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 52 weeks
Number of participants developing anti-drug antibodies
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer Metastatic
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
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.
Marcelo Tinelli, MD contact
Eduardo Spitzer, MSc study chair
Laboratorio Elea Phoenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pembrolizumab and Pembrolizumab biosimilar in people with Non Small Cell Lung Cancer Metastatic, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
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 19 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo Guthmann, PhD (+541144898300, marcelo.guthmann@elea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (area under the curve) (time frame: Four months). The study lists 3 primary outcomes in all. 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 16 Jul 2024.