Eine Studie zu Cemiplimab plus Chemotherapie im Vergleich zu Cemiplimab plus Chemotherapie plus anderen Krebsbehandlungen für erwachsene Patienten mit operablem nicht-kleinzelligem Lungenkrebs (NSCLC)
Eine randomisierte Phase-2-Plattformstudie zur Bewertung von Cemiplimab plus Chemotherapie im Vergleich zu Cemiplimab plus Chemotherapie plus anderen Krebsbehandlungen für die perioperative Behandlung von Patienten mit resektablem nicht-kleinzelligem Lungenkrebs
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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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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Aachen, Deutschland, 52074
- University Hospital RWTH Aachen
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Hesse
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Kassel, Hesse, Deutschland, 34125
- Klinikum Kassel GmbH, Hauttumorzentrum
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Lower Saxony
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Göttingen, Lower Saxony, Deutschland, 37083
- University Medicine Gottingen
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Saxony
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Leipzig, Saxony, Deutschland, 04103
- University of Leipzig
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Bayonne, Frankreich, 64100
- Clinique Belharra
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Bayonne, Frankreich, 64100
- Centre Hospitalier de la Cote Basque
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Grenoble, Frankreich, 38330
- CHU Grenoble Alpes
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Montpellier, Frankreich, 34295
- Montpellier Academic Hospital
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Brittany Region
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Rennes, Brittany Region, Frankreich, 35033
- CHU Rennes
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Var
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Toulon, Var, Frankreich, 83055
- Centre Hospitalier Intercommunal Toulon - CHITS
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Île-de-France Region
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Paris, Île-de-France Region, Frankreich, 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, Türkei (türkiye), 34295
- Florya Medical Park Hospital
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California
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Orange, California, Vereinigte Staaten, 92868
- University of California Irvine
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Illinois
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Skokie, Illinois, Vereinigte Staaten, 60077
- Orchard Healthcare Research Inc.
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201
- Karmanos Cancer Institute
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Farmington Hills, Michigan, Vereinigte Staaten, 48334
- Detroit Clinical Research Center
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45245
- Oncology Hematology Care Clinical Trials LLC
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97213
- Providence Portland Medical Center
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Portland, Oregon, Vereinigte Staaten, 97213
- University Of Nebraska Medical Center
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Lifespan Cancer Institute
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South Dakota
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Watertown, South Dakota, Vereinigte Staaten, 57201
- Prairie Lakes Healthcare System
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37920
- University of Tennessee Medical Center
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
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Virginia
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Blacksburg, Virginia, Vereinigte Staaten, 24060
- BRCC/Oncology & Hematology Associates of SW Virginia
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Neoadjuvant Resectable NSCLC - Control Arm
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Administered per the protocol
Andere Namen:
Administered per the protocol |
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Experimental: Neoadjuvant Resectable NSCLC - Arm 1
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Administered per the protocol
Andere Namen:
Administered per the protocol
Andere Namen:
Administered per the protocol |
|
Experimental: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
|
Administered per the protocol
Andere Namen:
Administered per the protocol Administered per the protocol
Andere Namen:
|
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Experimental: Neoadjuvant Resectable NSCLC - Arm 2
|
Administered per the protocol
Andere Namen:
Administered per the protocol Administered per the protocol
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Zeitfenster: Up to 12 weeks
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Up to 12 weeks
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|
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Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Zeitfenster: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
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Occurrence of TEAEs leading to death
Zeitfenster: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
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Occurrence of TEAEs leading to treatment discontinuation
Zeitfenster: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of Serious Adverse Events (SAEs)
Zeitfenster: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
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Occurrence of grade ≥3 laboratory abnormalities
Zeitfenster: 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
|
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Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
Zeitfenster: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gesamtüberleben (OS)
Zeitfenster: Bis zu 5 Jahre
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Bis zu 5 Jahre
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Schweregrad der TEAEs
Zeitfenster: Bis zu 76 Wochen
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Bis zu 76 Wochen
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Anteil verzögerter Operationen aufgrund von TEAEs
Zeitfenster: Bis zu 76 Wochen
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Bis zu 76 Wochen
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Anteil abgesagter Operationen aufgrund von TEAEs
Zeitfenster: Bis zu 76 Wochen
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Bis zu 76 Wochen
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Pathologic Complete Response (pCR) rate as determined by central BIPR
Zeitfenster: Up to 12 weeks
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Up to 12 weeks
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Residual Viable Tumor (RVT) as determined by central BIPR
Zeitfenster: Up to 12 weeks
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Up to 12 weeks
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Event-Free Survival (EFS)
Zeitfenster: Up to 5 years
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Up to 5 years
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|
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Objective Response by investigator assessment
Zeitfenster: Up to 9 weeks
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Up to 9 weeks
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|
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Duration of Response (DoR) by investigator assessment
Zeitfenster: Up to 2 years
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 2 years
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Occurrence of TEAEs
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Occurrence of TEAEs leading to death
Zeitfenster: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of TEAEs leading to treatment discontinuation
Zeitfenster: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of SAEs
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Severity of SAEs
Zeitfenster: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of Adverse Events of Special Interest (AESIs)
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Severity of AESIs
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Occurrence of immune-mediated Adverse Events (imAEs)
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Severity of imAEs
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Occurrence of Infusion-Related Reactions (IRRs)
Zeitfenster: Up to 76 weeks
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Up to 76 weeks
|
|
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Severity of IRRs
Zeitfenster: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of grade ≥3 laboratory abnormalities
Zeitfenster: 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
Zeitfenster: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to cemiplimab
Zeitfenster: Up to 67 weeks
|
Up to 67 weeks
|
|
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Occurrence of ADAs to marlotamig
Zeitfenster: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to marlotamig
Zeitfenster: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to REGN10597
Zeitfenster: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to REGN10597
Zeitfenster: Up to 67 weeks
|
Up to 67 weeks
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Clinical Trial Management, Regeneron Pharmaceuticals
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R2810-ONC-2268
- 2023 (US NIH Stipendium/Vertrag)
- 2023-509806-31-00 (Ctis)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-Sharing-Zeitrahmen
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-Sharing-Zugriffskriterien
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
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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