En undersøgelse af Cemiplimab Plus kemoterapi versus Cemiplimab Plus kemoterapi plus andre kræftbehandlinger til voksne patienter med operabel ikke-småcellet lungekræft (NSCLC)
Et randomiseret fase 2-platformsstudie til evaluering af Cemiplimab Plus kemoterapi versus Cemiplimab Plus kemoterapi plus andre kræftbehandlinger til perioperativ behandling af patienter med resektabel ikke-småcellet lungekræft
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.
The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."
The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.
For the resectable NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the investigational treatments in comparison to the control treatment
- Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
- How much of the study drug(s) are in the blood at a given time
- Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
- How does the additional drug work in combination with cemiplimab and chemotherapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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São Paulo, Brasilien, 01323-903
- Hospital Alemao Oswaldo Cruz
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasilien, 29306014
- Oncology Clinical Research Center
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30380-472
- Instituto Mario Penna
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Pouso Alegre, Minas Gerais, Brasilien, 37554-238
- Instituto Sul Mineiro De Oncologia LTDA
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Pernambuco
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Recife, Pernambuco, Brasilien, 50070-902
- Instituto de Medicina Integral Professor Fernando Figueira
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilien, 59060-195
- Liga Norte Riograndense Contra o Cancer
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Rio Grande do Sul, Brasilien, 90110-270
- Hospital Mae de Deus Integrated Oncology Center
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Santa Catarina
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Florianópolis, Santa Catarina, Brasilien, 88020-210
- Ynova Pesquisa Clinica
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São Paulo
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Sorocaba, São Paulo, Brasilien, 18065-100
- Unimed Sorocaba
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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California
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Orange, California, Forenede Stater, 92868
- University of California Irvine
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Illinois
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Skokie, Illinois, Forenede Stater, 60077
- Orchard Healthcare Research Inc.
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Karmanos Cancer Institute
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Farmington Hills, Michigan, Forenede Stater, 48334
- Detroit Clinical Research Center
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45245
- Oncology Hematology Care Clinical Trials LLC
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
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Portland, Oregon, Forenede Stater, 97213
- University Of Nebraska Medical Center
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Lifespan Cancer Institute
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South Dakota
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Watertown, South Dakota, Forenede Stater, 57201
- Prairie Lakes Healthcare System
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37920
- University of Tennessee Medical Center
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Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
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Virginia
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Blacksburg, Virginia, Forenede Stater, 24060
- BRCC/Oncology & Hematology Associates of SW Virginia
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Bayonne, Frankrig, 64100
- Clinique Belharra
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Bayonne, Frankrig, 64100
- Centre Hospitalier de la Cote Basque
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Grenoble, Frankrig, 38330
- CHU Grenoble Alpes
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Montpellier, Frankrig, 34295
- Montpellier Academic Hospital
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Brittany Region
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Rennes, Brittany Region, Frankrig, 35033
- CHU Rennes
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Var
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Toulon, Var, Frankrig, 83055
- Centre Hospitalier Intercommunal Toulon - CHITS
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Île-de-France Region
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Paris, Île-de-France Region, Frankrig, 75005
- Institut Curie
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Madrid, Spanien, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Spanien, 28033
- MD Anderson Cancer Center
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Madrid, Spanien, 28050
- Hospital Universitario HM Sanchinarro
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Seville, Spanien, 41013
- Hospital Virgen del Rocio
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Valencia, Spanien, 46014
- Consorci Hospital General Universitario de Valencia
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Valencia, Spanien, 46010
- Hospital Clinico Universitario Valencia
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Zaragoza, Spanien, 50009
- Hospital Clinico Lozano Blesa
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Catalan Instituye of Oncology Badalona
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Hospital Valdecilla
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Spanien, 35016
- Hospital Universitario Insular de Gran Canaria
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Clinica Universidad de Navarra
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Istanbul, Tyrkiet (Türkiye), 34295
- Florya Medical Park Hospital
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Aachen, Tyskland, 52074
- University Hospital RWTH Aachen
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Hesse
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Kassel, Hesse, Tyskland, 34125
- Klinikum Kassel GmbH, Hauttumorzentrum
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Lower Saxony
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Göttingen, Lower Saxony, Tyskland, 37083
- University Medicine Gottingen
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Saxony
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Leipzig, Saxony, Tyskland, 04103
- University of Leipzig
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:
- Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
- Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
- Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
- Adequate organ and bone marrow function, as described in the protocol
Arm Specific Inclusion Criteria:
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
- Availability of an archival or on-trial FFPE tumor tissue sample
- ECOG performance status of 0 or 1
- Per investigator judgment, life expectancy of at least 3 months
Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:
- Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
- Presence of grade≥ 2 peripheral neuropathy
- Another malignancy that is progressing or requires active treatment, as described in the protocol
Arm Specific Exclusion Criteria:
Neoadjuvant Resectable NSCLC - Arm 1:
- Grade ≥3 hypercalcemia, as defined in the protocol
- Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
- Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
- Known allergy or hypersensitivity to any components of trial interventions
- Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol
Neoadjuvant Resectable NSCLC - Arm 2:
1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Neoadjuvant Resectable NSCLC - Control Arm
|
Administered per the protocol
Andre navne:
Administered per the protocol |
|
Eksperimentel: Neoadjuvant Resectable NSCLC - Arm 1
|
Administered per the protocol
Andre navne:
Administered per the protocol
Andre navne:
Administered per the protocol |
|
Eksperimentel: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
|
Administered per the protocol
Andre navne:
Administered per the protocol Administered per the protocol
Andre navne:
|
|
Eksperimentel: Neoadjuvant Resectable NSCLC - Arm 2
|
Administered per the protocol
Andre navne:
Administered per the protocol Administered per the protocol
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to death
Tidsramme: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to treatment discontinuation
Tidsramme: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of Serious Adverse Events (SAEs)
Tidsramme: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of grade ≥3 laboratory abnormalities
Tidsramme: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 9 weeks
|
|
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
Tidsramme: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse (OS)
Tidsramme: Op til 5 år
|
Op til 5 år
|
|
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Sværhedsgraden af TEAE'er
Tidsramme: Op til 76 uger
|
Op til 76 uger
|
|
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Andel af forsinkede operationer på grund af TEAE
Tidsramme: Op til 76 uger
|
Op til 76 uger
|
|
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Andel af aflyste operationer på grund af TEAE
Tidsramme: Op til 76 uger
|
Op til 76 uger
|
|
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Pathologic Complete Response (pCR) rate as determined by central BIPR
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
|
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Residual Viable Tumor (RVT) as determined by central BIPR
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
|
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Event-Free Survival (EFS)
Tidsramme: Up to 5 years
|
Up to 5 years
|
|
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Objective Response by investigator assessment
Tidsramme: Up to 9 weeks
|
Up to 9 weeks
|
|
|
Duration of Response (DoR) by investigator assessment
Tidsramme: Up to 2 years
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 2 years
|
|
Occurrence of TEAEs
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to death
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to treatment discontinuation
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of SAEs
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of SAEs
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Adverse Events of Special Interest (AESIs)
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of AESIs
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of immune-mediated Adverse Events (imAEs)
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of imAEs
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Infusion-Related Reactions (IRRs)
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of IRRs
Tidsramme: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of grade ≥3 laboratory abnormalities
Tidsramme: Up to 76 weeks
|
As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 76 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
Tidsramme: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to cemiplimab
Tidsramme: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to marlotamig
Tidsramme: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to marlotamig
Tidsramme: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to REGN10597
Tidsramme: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to REGN10597
Tidsramme: Up to 67 weeks
|
Up to 67 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R2810-ONC-2268
- 2023 (U.S. NIH-bevilling/kontrakt)
- 2023-509806-31-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD-delingsadgangskriterier
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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