Studie chemoterapie cemiplimab plus versus chemoterapie cemiplimab plus plus další léčba rakoviny u dospělých pacientů s operabilním nemalobuněčným karcinomem plic (NSCLC)
Randomizovaná studie platformy 2 k vyhodnocení chemoterapie cemiplimab plus versus cemiplimab plus chemoterapie plus jiné léčby rakoviny pro perioperační léčbu pacientů s resekabilním nemalobuněčným karcinomem plic
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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São Paulo, Brazílie, 01323-903
- Hospital Alemao Oswaldo Cruz
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brazílie, 29306014
- Oncology Clinical Research Center
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazílie, 30380-472
- Instituto Mario Penna
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Pouso Alegre, Minas Gerais, Brazílie, 37554-238
- Instituto Sul Mineiro De Oncologia LTDA
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Pernambuco
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Recife, Pernambuco, Brazílie, 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, Brazílie, 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, Brazílie, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Rio Grande do Sul, Brazílie, 90110-270
- Hospital Mae de Deus Integrated Oncology Center
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Santa Catarina
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Florianópolis, Santa Catarina, Brazílie, 88020-210
- Ynova Pesquisa Clinica
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São Paulo
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Sorocaba, São Paulo, Brazílie, 18065-100
- Unimed Sorocaba
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São José do Rio Preto, São Paulo, Brazílie, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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Bayonne, Francie, 64100
- Clinique Belharra
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Bayonne, Francie, 64100
- Centre Hospitalier de la Cote Basque
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Grenoble, Francie, 38330
- CHU Grenoble Alpes
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Montpellier, Francie, 34295
- Montpellier Academic Hospital
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Brittany Region
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Rennes, Brittany Region, Francie, 35033
- CHU Rennes
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Var
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Toulon, Var, Francie, 83055
- Centre Hospitalier Intercommunal Toulon - CHITS
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Île-de-France Region
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Paris, Île-de-France Region, Francie, 75005
- Institut Curie
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Aachen, Německo, 52074
- University Hospital RWTH Aachen
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Hesse
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Kassel, Hesse, Německo, 34125
- Klinikum Kassel GmbH, Hauttumorzentrum
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Lower Saxony
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Göttingen, Lower Saxony, Německo, 37083
- University Medicine Gottingen
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Saxony
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Leipzig, Saxony, Německo, 04103
- University of Leipzig
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California
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Orange, California, Spojené státy, 92868
- University of California Irvine
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Illinois
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Skokie, Illinois, Spojené státy, 60077
- Orchard Healthcare Research Inc.
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Michigan
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Detroit, Michigan, Spojené státy, 48201
- Karmanos Cancer Institute
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Farmington Hills, Michigan, Spojené státy, 48334
- Detroit Clinical Research Center
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Ohio
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Cincinnati, Ohio, Spojené státy, 45245
- Oncology Hematology Care Clinical Trials LLC
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Oregon
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Portland, Oregon, Spojené státy, 97213
- Providence Portland Medical Center
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Portland, Oregon, Spojené státy, 97213
- University Of Nebraska Medical Center
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Lifespan Cancer Institute
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South Dakota
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Watertown, South Dakota, Spojené státy, 57201
- Prairie Lakes Healthcare System
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Tennessee
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Knoxville, Tennessee, Spojené státy, 37920
- University of Tennessee Medical Center
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Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
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Virginia
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Blacksburg, Virginia, Spojené státy, 24060
- BRCC/Oncology & Hematology Associates of SW Virginia
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Istanbul, Turecko (Türkiye), 34295
- Florya Medical Park Hospital
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Madrid, Španělsko, 28046
- Hospital Universitario La Paz
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Madrid, Španělsko, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Španělsko, 28033
- MD Anderson Cancer Center
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Madrid, Španělsko, 28050
- Hospital Universitario HM Sanchinarro
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Seville, Španělsko, 41013
- Hospital Virgen del Rocio
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Valencia, Španělsko, 46014
- Consorci Hospital General Universitario de Valencia
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Valencia, Španělsko, 46010
- Hospital Clinico Universitario Valencia
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Zaragoza, Španělsko, 50009
- Hospital Clinico Lozano Blesa
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Barcelona
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Badalona, Barcelona, Španělsko, 08916
- Catalan Instituye of Oncology Badalona
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Cantabria
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Santander, Cantabria, Španělsko, 39008
- Hospital Valdecilla
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Španělsko, 35016
- Hospital Universitario Insular de Gran Canaria
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Navarre
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Pamplona, Navarre, Španělsko, 31008
- Clinica Universidad de Navarra
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Neoadjuvant Resectable NSCLC - Control Arm
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Administered per the protocol
Ostatní jména:
Administered per the protocol |
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Experimentální: Neoadjuvant Resectable NSCLC - Arm 1
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Administered per the protocol
Ostatní jména:
Administered per the protocol
Ostatní jména:
Administered per the protocol |
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Experimentální: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
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Administered per the protocol
Ostatní jména:
Administered per the protocol Administered per the protocol
Ostatní jména:
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Experimentální: Neoadjuvant Resectable NSCLC - Arm 2
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Administered per the protocol
Ostatní jména:
Administered per the protocol Administered per the protocol
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Časové okno: Up to 12 weeks
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Up to 12 weeks
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Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Časové okno: 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
Časové okno: 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
Časové okno: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
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Occurrence of Serious Adverse Events (SAEs)
Časové okno: 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 grade ≥3 laboratory abnormalities
Časové okno: Up to 9 weeks
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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
Časové okno: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Celkové přežití (OS)
Časové okno: Až 5 let
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Až 5 let
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Závažnost TEAE
Časové okno: Až 76 týdnů
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Až 76 týdnů
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Podíl opožděných operací v důsledku TEAE
Časové okno: Až 76 týdnů
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Až 76 týdnů
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Podíl zrušených operací kvůli TEAE
Časové okno: Až 76 týdnů
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Až 76 týdnů
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Pathologic Complete Response (pCR) rate as determined by central BIPR
Časové okno: 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
Časové okno: Up to 12 weeks
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Up to 12 weeks
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Event-Free Survival (EFS)
Časové okno: Up to 5 years
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Up to 5 years
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Objective Response by investigator assessment
Časové okno: Up to 9 weeks
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Up to 9 weeks
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Duration of Response (DoR) by investigator assessment
Časové okno: 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
Časové okno: Up to 76 weeks
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Up to 76 weeks
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Occurrence of TEAEs leading to death
Časové okno: Up to 76 weeks
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Up to 76 weeks
|
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Occurrence of TEAEs leading to treatment discontinuation
Časové okno: Up to 76 weeks
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Up to 76 weeks
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Occurrence of SAEs
Časové okno: Up to 76 weeks
|
Up to 76 weeks
|
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Severity of SAEs
Časové okno: Up to 76 weeks
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Up to 76 weeks
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Occurrence of Adverse Events of Special Interest (AESIs)
Časové okno: Up to 76 weeks
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Up to 76 weeks
|
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Severity of AESIs
Časové okno: Up to 76 weeks
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Up to 76 weeks
|
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Occurrence of immune-mediated Adverse Events (imAEs)
Časové okno: Up to 76 weeks
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Up to 76 weeks
|
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Severity of imAEs
Časové okno: Up to 76 weeks
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Up to 76 weeks
|
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Occurrence of Infusion-Related Reactions (IRRs)
Časové okno: Up to 76 weeks
|
Up to 76 weeks
|
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Severity of IRRs
Časové okno: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of grade ≥3 laboratory abnormalities
Časové okno: 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
|
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Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
Časové okno: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to cemiplimab
Časové okno: Up to 67 weeks
|
Up to 67 weeks
|
|
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Occurrence of ADAs to marlotamig
Časové okno: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to marlotamig
Časové okno: Up to 67 weeks
|
Up to 67 weeks
|
|
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Occurrence of ADAs to REGN10597
Časové okno: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to REGN10597
Časové okno: Up to 67 weeks
|
Up to 67 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Clinical Trial Management, Regeneron Pharmaceuticals
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R2810-ONC-2268
- 2023 (Grant/smlouva NIH USA)
- 2023-509806-31-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Časový rámec sdílení IPD
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
Kritéria přístupu pro sdílení IPD
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
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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