Badanie dotyczące chemioterapii Cemiplimabem w skojarzeniu z chemioterapią Cemiplimabem w skojarzeniu z innymi metodami leczenia raka u dorosłych pacjentów z operacyjnym niedrobnokomórkowym rakiem płuc (NSCLC)
Randomizowane badanie platformowe fazy 2 mające na celu ocenę chemioterapii Cemiplimabem w skojarzeniu z chemioterapią Cemiplimabem w skojarzeniu z innymi terapiami przeciwnowotworowymi w leczeniu okołooperacyjnym pacjentów z resekcyjnym niedrobnokomórkowym rakiem płuc
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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São Paulo, Brazylia, 01323-903
- Hospital Alemao Oswaldo Cruz
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brazylia, 29306014
- Oncology Clinical Research Center
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazylia, 30380-472
- Instituto Mario Penna
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Pouso Alegre, Minas Gerais, Brazylia, 37554-238
- Instituto Sul Mineiro De Oncologia LTDA
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Pernambuco
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Recife, Pernambuco, Brazylia, 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, Brazylia, 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, Brazylia, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Rio Grande do Sul, Brazylia, 90110-270
- Hospital Mae de Deus Integrated Oncology Center
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Santa Catarina
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Florianópolis, Santa Catarina, Brazylia, 88020-210
- Ynova Pesquisa Clinica
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São Paulo
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Sorocaba, São Paulo, Brazylia, 18065-100
- Unimed Sorocaba
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São José do Rio Preto, São Paulo, Brazylia, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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Bayonne, Francja, 64100
- Clinique Belharra
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Bayonne, Francja, 64100
- Centre Hospitalier de la Cote Basque
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Grenoble, Francja, 38330
- CHU Grenoble Alpes
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Montpellier, Francja, 34295
- Montpellier Academic Hospital
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Brittany Region
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Rennes, Brittany Region, Francja, 35033
- CHU Rennes
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Var
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Toulon, Var, Francja, 83055
- Centre Hospitalier Intercommunal Toulon - CHITS
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Île-de-France Region
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Paris, Île-de-France Region, Francja, 75005
- Institut Curie
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Madrid, Hiszpania, 28046
- Hospital Universitario La Paz
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Madrid, Hiszpania, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Hiszpania, 28033
- MD Anderson Cancer Center
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Madrid, Hiszpania, 28050
- Hospital Universitario HM Sanchinarro
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Seville, Hiszpania, 41013
- Hospital Virgen del Rocio
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Valencia, Hiszpania, 46014
- Consorci Hospital General Universitario de Valencia
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Valencia, Hiszpania, 46010
- Hospital Clinico Universitario Valencia
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Zaragoza, Hiszpania, 50009
- Hospital Clinico Lozano Blesa
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Barcelona
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Badalona, Barcelona, Hiszpania, 08916
- Catalan Instituye of Oncology Badalona
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Cantabria
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Santander, Cantabria, Hiszpania, 39008
- Hospital Valdecilla
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Hiszpania, 35016
- Hospital Universitario Insular de Gran Canaria
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Navarre
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Pamplona, Navarre, Hiszpania, 31008
- Clinica Universidad de Navarra
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Aachen, Niemcy, 52074
- University Hospital RWTH Aachen
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Hesse
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Kassel, Hesse, Niemcy, 34125
- Klinikum Kassel GmbH, Hauttumorzentrum
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Lower Saxony
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Göttingen, Lower Saxony, Niemcy, 37083
- University Medicine Gottingen
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Saxony
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Leipzig, Saxony, Niemcy, 04103
- University of Leipzig
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California
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Orange, California, Stany Zjednoczone, 92868
- University of California Irvine
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Illinois
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Skokie, Illinois, Stany Zjednoczone, 60077
- Orchard Healthcare Research Inc.
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201
- Karmanos Cancer Institute
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Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Detroit Clinical Research Center
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45245
- Oncology Hematology Care Clinical Trials LLC
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97213
- Providence Portland Medical Center
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Portland, Oregon, Stany Zjednoczone, 97213
- University Of Nebraska Medical Center
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Lifespan Cancer Institute
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South Dakota
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Watertown, South Dakota, Stany Zjednoczone, 57201
- Prairie Lakes Healthcare System
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Tennessee
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Knoxville, Tennessee, Stany Zjednoczone, 37920
- University of Tennessee Medical Center
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
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Virginia
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Blacksburg, Virginia, Stany Zjednoczone, 24060
- BRCC/Oncology & Hematology Associates of SW Virginia
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Istanbul, Turcja (Türkiye), 34295
- Florya Medical Park Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Neoadjuvant Resectable NSCLC - Control Arm
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Administered per the protocol
Inne nazwy:
Administered per the protocol |
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Eksperymentalny: Neoadjuvant Resectable NSCLC - Arm 1
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Administered per the protocol
Inne nazwy:
Administered per the protocol
Inne nazwy:
Administered per the protocol |
|
Eksperymentalny: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
|
Administered per the protocol
Inne nazwy:
Administered per the protocol Administered per the protocol
Inne nazwy:
|
|
Eksperymentalny: Neoadjuvant Resectable NSCLC - Arm 2
|
Administered per the protocol
Inne nazwy:
Administered per the protocol Administered per the protocol
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Ramy czasowe: Up to 12 weeks
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Up to 12 weeks
|
|
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Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Ramy czasowe: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to death
Ramy czasowe: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to treatment discontinuation
Ramy czasowe: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of Serious Adverse Events (SAEs)
Ramy czasowe: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of grade ≥3 laboratory abnormalities
Ramy czasowe: 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
Ramy czasowe: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Całkowite przeżycie (OS)
Ramy czasowe: Do 5 lat
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Do 5 lat
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Nasilenie TEAE
Ramy czasowe: Do 76 tygodni
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Do 76 tygodni
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Odsetek opóźnionych operacji z powodu TEAE
Ramy czasowe: Do 76 tygodni
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Do 76 tygodni
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Odsetek odwołanych operacji z powodu TEAE
Ramy czasowe: Do 76 tygodni
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Do 76 tygodni
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Pathologic Complete Response (pCR) rate as determined by central BIPR
Ramy czasowe: 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
Ramy czasowe: Up to 12 weeks
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Up to 12 weeks
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Event-Free Survival (EFS)
Ramy czasowe: Up to 5 years
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Up to 5 years
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Objective Response by investigator assessment
Ramy czasowe: Up to 9 weeks
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Up to 9 weeks
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Duration of Response (DoR) by investigator assessment
Ramy czasowe: 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
Ramy czasowe: Up to 76 weeks
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Up to 76 weeks
|
|
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Occurrence of TEAEs leading to death
Ramy czasowe: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of TEAEs leading to treatment discontinuation
Ramy czasowe: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of SAEs
Ramy czasowe: Up to 76 weeks
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Up to 76 weeks
|
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Severity of SAEs
Ramy czasowe: Up to 76 weeks
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Up to 76 weeks
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Occurrence of Adverse Events of Special Interest (AESIs)
Ramy czasowe: Up to 76 weeks
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Up to 76 weeks
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Severity of AESIs
Ramy czasowe: Up to 76 weeks
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Up to 76 weeks
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Occurrence of immune-mediated Adverse Events (imAEs)
Ramy czasowe: Up to 76 weeks
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Up to 76 weeks
|
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Severity of imAEs
Ramy czasowe: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of Infusion-Related Reactions (IRRs)
Ramy czasowe: Up to 76 weeks
|
Up to 76 weeks
|
|
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Severity of IRRs
Ramy czasowe: Up to 76 weeks
|
Up to 76 weeks
|
|
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Occurrence of grade ≥3 laboratory abnormalities
Ramy czasowe: 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
Ramy czasowe: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to cemiplimab
Ramy czasowe: Up to 67 weeks
|
Up to 67 weeks
|
|
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Occurrence of ADAs to marlotamig
Ramy czasowe: Up to 67 weeks
|
Up to 67 weeks
|
|
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Magnitude of ADAs to marlotamig
Ramy czasowe: Up to 67 weeks
|
Up to 67 weeks
|
|
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Occurrence of ADAs to REGN10597
Ramy czasowe: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to REGN10597
Ramy czasowe: Up to 67 weeks
|
Up to 67 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Clinical Trial Management, Regeneron Pharmaceuticals
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R2810-ONC-2268
- 2023 (Grant/umowa NIH USA)
- 2023-509806-31-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Ramy czasowe udostępniania 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
Kryteria dostępu do udostępniania 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 informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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