Neoadjuvant och adjuvant behandling vid resektabel icke-småcellig lungcancer (NeoCOAST-2)
En fas II, öppen, multicenter, randomiserad studie av neoadjuvant och adjuvant behandling hos patienter med resektabel, tidigt stadium (II till IIIB) icke-småcellig lungcancer (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studera Kontakt Backup
- Namn: AstraZeneca Lung Cancer Study Locator Service
- Telefonnummer: 1-884-432-3892
- E-post: az-lcsl@careboxhealth.com
Studieorter
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Ghent, Belgien, 9000
- Avslutad
- Research Site
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Ghent, Belgien, 9000
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Roeselare, Belgien, 8800
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Avignon, Frankrike, 84902
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Bobigny, Frankrike, 93009
- Indragen
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Bordeaux, Frankrike, 33076
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Limoges, Frankrike, 83000
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Rennes, Frankrike, 35000
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Rouen, Frankrike, 76031
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Suresnes, Frankrike, 92150
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Toulon, Frankrike, 83000
- Aktiv, inte rekryterande
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Rekrytering
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California
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Los Angeles, California, Förenta staterna, 90095
- Rekrytering
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Oakland, California, Förenta staterna, 94611
- Indragen
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06510
- Rekrytering
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Florida
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Stuart, Florida, Förenta staterna, 34994
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Georgia
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Gainesville, Georgia, Förenta staterna, 30501
- Indragen
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
- Rekrytering
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Maryland
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Baltimore, Maryland, Förenta staterna, 21231
- Rekrytering
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Baltimore, Maryland, Förenta staterna, 21201
- Indragen
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Rekrytering
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Minnesota
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Saint Louis Park, Minnesota, Förenta staterna, 55426
- Avslutad
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68124
- Rekrytering
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New York
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Buffalo, New York, Förenta staterna, 14263
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
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Tennessee
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Chattanooga, Tennessee, Förenta staterna, 37404
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Memphis, Tennessee, Förenta staterna, 38120
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Nashville, Tennessee, Förenta staterna, 37232
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Nashville, Tennessee, Förenta staterna, 37203
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Nashville, Tennessee, Förenta staterna, 37203
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Texas
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Houston, Texas, Förenta staterna, 77030
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Houston, Texas, Förenta staterna, 77090
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
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Washington
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Edmonds, Washington, Förenta staterna, 98026
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Seattle, Washington, Förenta staterna, 98104
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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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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 0V9
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Quebec
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Montreal, Quebec, Kanada, H2X 3E4
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Montreal, Quebec, Kanada, H2W 1S6
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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
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Porto, Portugal, 4200-072
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Porto, Portugal, 4099-001
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Porto, Portugal, 4100-180
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A Coruña, Spanien, 15006
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Alicante, Spanien, 03010
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Barcelona, Spanien, 08036
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Barcelona, Spanien, 8035
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Córdoba, Spanien, 14004
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Madrid, Spanien, 28040
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Majadahonda, Spanien, 28250
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Málaga, Spanien, 29010
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Reus, Spanien, 43204
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Seville, Spanien, 41009
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Terrassa, Spanien, 08221
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Valencia, Spanien, 46010
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Busan, Sydkorea, 48108
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Chungcheongbuk-do, Sydkorea, 28644
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Seongnam-si, Sydkorea, 13496
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Seoul, Sydkorea, 03080
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Seoul, Sydkorea, 05505
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Suwon, Sydkorea, 16247
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Suwon, Sydkorea, 440-746
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Liuying, Taiwan, 736
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New Taipei City, Taiwan, 235
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 11217
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Ankara, Turkiet (Türkiye), 06800
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Ankara, Turkiet (Türkiye), 06010
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Ankara, Turkiet (Türkiye), 06500
- Rekrytering
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Istanbul, Turkiet (Türkiye), 34722
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Izmir, Turkiet (Türkiye), 35575
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Kecskemét, Ungern, 6000
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Székesfehérvár, Ungern, 8000
- Rekrytering
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Tatabánya, Ungern, 2800
- Avslutad
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Törökbálint, Ungern, 2045
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
Participants will receive Oleclumab via intravenous route.
Andra namn:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy |
|
Experimentell: 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.
Andra namn:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Monalizumab via intravenous route.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Carboplatin as chemotherapy Cisplatin as chemotherapy |
|
Experimentell: 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.
Andra namn:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive AZD0171 via intravenous route. |
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Antal deltagare med patologiskt fullständigt svar (pCR)
Tidsram: Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
|
Antal deltagare med biverkningar (AE) och allvarliga biverkningar (SAE)
Tidsram: Till dag 90 efter den sista dosen av studieinterventioner (upp till cirka 3 år)
|
Till dag 90 efter den sista dosen av studieinterventioner (upp till cirka 3 år)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Antal deltagare som upplever ett event-free survival (EFS) event
Tidsram: Upp till cirka 3 år
|
Upp till cirka 3 år
|
|
Antal deltagare som upplever en sjukdomsfri överlevnad (DFS) händelse
Tidsram: Upp till cirka 3 år
|
Upp till cirka 3 år
|
|
Antal deltagare som har kirurgisk resektion
Tidsram: Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
|
Antal deltagare med stor patologisk respons (mPR)
Tidsram: Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
|
Antal deltagare med objektiv svarsfrekvens (ORR)
Tidsram: Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
Från randomisering till cirka 15 veckor efter den första dosen av studieinterventioner
|
|
Total överlevnad (OS)
Tidsram: Upp till cirka 3 år
|
Upp till cirka 3 år
|
|
Antal deltagare med anti-studieläkemedelsantikroppar (ADA)
Tidsram: Från randomisering till 3 månader efter sista dos av studieinterventioner (upp till cirka 3 år)
|
Från randomisering till 3 månader efter sista dos av studieinterventioner (upp till cirka 3 år)
|
|
Baslinje PD-L1 uttryck
Tidsram: Vid Screening/baslinje
|
Vid Screening/baslinje
|
|
Förändringar i cirkulerande tumör-DNA (ctDNA)
Tidsram: Från randomisering till upp till 24 månader efter sista dos av studieinterventioner (upp till cirka 3 år)
|
Från randomisering till upp till 24 månader efter sista dos av studieinterventioner (upp till cirka 3 år)
|
|
Serumkoncentration av studieinterventioner (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)
Tidsram: Från randomisering till sista dos av studieinterventioner (upp till cirka 3 år)
|
Från randomisering till sista dos av studieinterventioner (upp till cirka 3 år)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tina Cascone, MD, MD Anderson Cancer Center Houston, TX 77030
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Aminosyror, peptider och proteiner
- Organiska kemikalier
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Oorganiska kemikalier
- Klorföreningar
- Kväveföreningar
- Koordinationskomplex
- Guanin
- Hypoxantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyror, sur
- Aminosyror
- Aminosyror, dikarboxyl
- Platinaföreningar
- Pemetrexed
- Karboplatin
- Cisplatin
- durvalumab
- monalizumab
- CP -protokoll
Andra studie-ID-nummer
- D9077C00001
- 2021-003369-37 (EudraCT-nummer)
- 2023-508852-21-00 (Registeridentifierare: CTIS)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
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