Neoadjuverende og adjuverende behandling ved resektabel ikke-småcellet lungekræft (NeoCOAST-2)
Et fase II, åbent, multicenter, randomiseret undersøgelse af neoadjuverende og adjuverende behandling hos patienter med resektabel, tidligt stadium (II til IIIB) ikke-småcellet lungekræft (NeoCOAST-2)
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.
Arm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.
Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.
Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.
Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment.
Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.
Arm 6: Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.
Arm 7: Participants will receive Dato-DXd + Rilvegostomig + single agent platinum chemotherapy as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Undersøgelse Kontakt Backup
- Navn: AstraZeneca Lung Cancer Study Locator Service
- Telefonnummer: 1-884-432-3892
- E-mail: az-lcsl@careboxhealth.com
Studiesteder
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Ghent, Belgien, 9000
- Afsluttet
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Ghent, Belgien, 9000
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Roeselare, Belgien, 8800
- Rekruttering
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Afsluttet
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Rekruttering
- Research Site
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Rekruttering
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Montreal, Quebec, Canada, H2W 1S6
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Rekruttering
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California
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
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Oakland, California, Forenede Stater, 94611
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
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Florida
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Stuart, Florida, Forenede Stater, 34994
- Afsluttet
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Georgia
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Gainesville, Georgia, Forenede Stater, 30501
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
- Rekruttering
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Baltimore, Maryland, Forenede Stater, 21201
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
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Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55426
- Afsluttet
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68124
- Rekruttering
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New York
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Buffalo, New York, Forenede Stater, 14263
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Rekruttering
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
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Memphis, Tennessee, Forenede Stater, 38120
- Rekruttering
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
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Nashville, Tennessee, Forenede Stater, 37203
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Texas
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Houston, Texas, Forenede Stater, 77030
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Houston, Texas, Forenede Stater, 77090
- Afsluttet
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
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Washington
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Edmonds, Washington, Forenede Stater, 98026
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Seattle, Washington, Forenede Stater, 98104
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Avignon, Frankrig, 84902
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Bobigny, Frankrig, 93009
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Bordeaux, Frankrig, 33076
- Rekruttering
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Limoges, Frankrig, 83000
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Rennes, Frankrig, 35000
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Rouen, Frankrig, 76031
- Rekruttering
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Suresnes, Frankrig, 92150
- Rekruttering
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Toulon, Frankrig, 83000
- Aktiv, ikke rekrutterende
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Dublin, Irland, D08 NHY1
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Dublin, Irland, D07 R2WY
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Dublin, Irland, D09 V2N0
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Galway, Irland, H91 YR71
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Aviano, Italien, 33081
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Brescia, Italien, 25123
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Catanzaro, Italien, 88100
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Florence, Italien, 50134
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Genova, Italien, 16100
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Meldola, Italien, 47014
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Milan, Italien, 20162
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Monza, Italien, 20900
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Padova, Italien, 35128
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Perugia, Italien, 06156
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Pisa, Italien, 56124
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Roma, Italien, 00144
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Rozzano, Italien, 20089
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Lisbon, Portugal, 1169-050
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Lisbon, Portugal, 1099-023
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Lisbon, Portugal, 1400-038
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Lisbon, Portugal, 1500-650
- Rekruttering
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Porto, Portugal, 4200-072
- Rekruttering
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Porto, Portugal, 4099-001
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Porto, Portugal, 4100-180
- Afsluttet
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A Coruña, Spanien, 15006
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Alicante, Spanien, 03010
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Barcelona, Spanien, 08036
- Rekruttering
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Barcelona, Spanien, 8035
- Afsluttet
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Córdoba, Spanien, 14004
- Rekruttering
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Madrid, Spanien, 28040
- Rekruttering
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Majadahonda, Spanien, 28250
- Rekruttering
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Málaga, Spanien, 29010
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Reus, Spanien, 43204
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Seville, Spanien, 41009
- Rekruttering
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Terrassa, Spanien, 08221
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Valencia, Spanien, 46010
- Rekruttering
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Busan, Sydkorea, 48108
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Chungcheongbuk-do, Sydkorea, 28644
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Seongnam-si, Sydkorea, 13496
- Rekruttering
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Seoul, Sydkorea, 03080
- Rekruttering
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Seoul, Sydkorea, 05505
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Suwon, Sydkorea, 16247
- Rekruttering
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Suwon, Sydkorea, 440-746
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Liuying, Taiwan, 736
- Rekruttering
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New Taipei City, Taiwan, 235
- Rekruttering
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Tainan, Taiwan, 70403
- Rekruttering
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Taipei, Taiwan, 10002
- Rekruttering
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Taipei, Taiwan, 11217
- Rekruttering
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Ankara, Tyrkiet (Türkiye), 06800
- Rekruttering
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Ankara, Tyrkiet (Türkiye), 06010
- Rekruttering
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Ankara, Tyrkiet (Türkiye), 06500
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Istanbul, Tyrkiet (Türkiye), 34722
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Izmir, Tyrkiet (Türkiye), 35575
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Kecskemét, Ungarn, 6000
- Rekruttering
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Székesfehérvár, Ungarn, 8000
- Rekruttering
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Tatabánya, Ungarn, 2800
- Afsluttet
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Törökbálint, Ungarn, 2045
- Rekruttering
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
- WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
- Adequate pulmonary function.
Exclusion Criteria:
- Participants with sensitising EGFR mutations or ALK translocations.
- Participants with baseline PD-L1 expression status <1% (Arms 6 and 7 only).
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
- History of another primary malignancy.
- Participants with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- History of non-infectious interstitial lung disease (ILD) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Participants who have preoperative radiotherapy treatment as part of their care plan.
- Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
- QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Participants with moderate or severe cardiovascular disease.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
- Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
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 |
|---|---|
|
Eksperimentel: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Participants will receive Durvalumab via intravenous route.
Andre navne:
Participants will receive Oleclumab via intravenous route.
Andre navne:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy |
|
Eksperimentel: Arm 2: Monalizumab + Durvalumab + CTX
Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Participants will receive Durvalumab via intravenous route.
Andre navne:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Monalizumab via intravenous route.
Andre navne:
|
|
Eksperimentel: Arm 3: Volrustomig (Dose Exploration) + CTX
Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Volrustomig via intravenous route.
Andre navne:
|
|
Eksperimentel: Arm 4: Dato-DXd + durvalumab + single agent platinum
Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin |
Participants will receive Durvalumab via intravenous route.
Andre navne:
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Carboplatin as chemotherapy Cisplatin as chemotherapy |
|
Eksperimentel: Arm 5: AZD0171 + durvalumab + CTX
Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Participants will receive Durvalumab via intravenous route.
Andre navne:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive AZD0171 via intravenous route. |
|
Eksperimentel: Arm 6: Rilvegostomig + CTX
Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Rilvegostomig via intravenous route. |
|
Eksperimentel: Arm 7: Dato-DXd + Rilvegostomig + single agent platinum
Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin |
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Carboplatin as chemotherapy Cisplatin as chemotherapy Participants will receive Rilvegostomig via intravenous route. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antal deltagere med patologisk komplet respons (pCR)
Tidsramme: Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
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Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
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Antal deltagere med bivirkninger (AE'er) og alvorlige bivirkninger (SAE'er)
Tidsramme: Indtil dag 90 efter den sidste dosis af undersøgelsesinterventioner (Op til ca. 3 år)
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Indtil dag 90 efter den sidste dosis af undersøgelsesinterventioner (Op til ca. 3 år)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antal deltagere, der oplever en event-free survival (EFS) begivenhed
Tidsramme: Op til cirka 3 år
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Op til cirka 3 år
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Antal deltagere, der oplever en sygdomsfri overlevelse (DFS) begivenhed
Tidsramme: Op til cirka 3 år
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Op til cirka 3 år
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Antal deltagere med kirurgisk resektion
Tidsramme: Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
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Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
|
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Antal deltagere med større patologisk respons (mPR)
Tidsramme: Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
|
Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
|
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Antal deltagere med objektiv svarprocent (ORR)
Tidsramme: Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
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Fra randomisering til cirka 15 uger efter den første dosis af undersøgelsesinterventioner
|
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Samlet overlevelse (OS)
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
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Antal deltagere med anti-studiemedicin antistoffer (ADA)
Tidsramme: Fra randomisering til 3 måneder efter sidste dosis af undersøgelsesinterventioner (op til ca. 3 år)
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Fra randomisering til 3 måneder efter sidste dosis af undersøgelsesinterventioner (op til ca. 3 år)
|
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Baseline PD-L1 ekspression
Tidsramme: Ved Screening/ baseline
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Ved Screening/ baseline
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Ændringer i cirkulerende tumor-DNA (ctDNA)
Tidsramme: Fra randomisering til op til 24 måneder efter sidste dosis af undersøgelsesinterventioner (op til ca. 3 år)
|
Fra randomisering til op til 24 måneder efter sidste dosis af undersøgelsesinterventioner (op til ca. 3 år)
|
|
Serumkoncentration af undersøgelsesinterventioner (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)
Tidsramme: Fra randomisering til sidste dosis af undersøgelsesinterventioner (op til ca. 3 år)
|
Fra randomisering til sidste dosis af undersøgelsesinterventioner (op til ca. 3 år)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tina Cascone, MD, MD Anderson Cancer Center Houston, TX 77030
Publikationer og nyttige links
Hjælpsomme links
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
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinationskomplekser
- Guanine
- Hypoxanthines
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sur
- Aminosyrer
- Aminosyrer, dicarboxylic
- Platinforbindelser
- Pemetrexed
- Carboplatin
- Cisplatin
- Durvalumab
- Monalizumab
- CP -protokol
Andre undersøgelses-id-numre
- D9077C00001
- 2021-003369-37 (EudraCT nummer)
- 2023-508852-21-00 (Registry Identifier: CTIS)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD-delingsadgangskriterier
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .