Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
NCT ID: NCT05061550
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
630 participants
INTERVENTIONAL
2022-04-14
2030-05-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Durvalumab
Participants will receive Durvalumab via intravenous route.
Oleclumab
Participants will receive Oleclumab via intravenous route.
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
Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Durvalumab
Participants will receive Durvalumab via intravenous route.
Monalizumab
Participants will receive Monalizumab via intravenous route.
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
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Volrustomig
Participants will receive Volrustomig via intravenous route.
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
Carboplatin
Carboplatin as chemotherapy
Cisplatin
Cisplatin as chemotherapy
Durvalumab
Participants will receive Durvalumab via intravenous route.
Dato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
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
AZD0171
Participants will receive AZD0171 via intravenous route.
Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Durvalumab
Participants will receive Durvalumab via intravenous route.
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
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Rilvegostomig
Participants will receive Rilvegostomig via intravenous route.
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
Carboplatin
Carboplatin as chemotherapy
Cisplatin
Cisplatin as chemotherapy
Rilvegostomig
Participants will receive Rilvegostomig via intravenous route.
Dato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
Interventions
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AZD0171
Participants will receive AZD0171 via intravenous route.
Carboplatin
Carboplatin as chemotherapy
Cisplatin
Cisplatin as chemotherapy
Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Volrustomig
Participants will receive Volrustomig via intravenous route.
Rilvegostomig
Participants will receive Rilvegostomig via intravenous route.
Durvalumab
Participants will receive Durvalumab via intravenous route.
Oleclumab
Participants will receive Oleclumab via intravenous route.
Monalizumab
Participants will receive Monalizumab via intravenous route.
Dato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
95 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tina Cascone, MD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center Houston, TX 77030
Locations
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Research Site
Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Oakland, California, United States
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New Haven, Connecticut, United States
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Stuart, Florida, United States
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Gainesville, Georgia, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Saint Louis Park, Minnesota, United States
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Omaha, Nebraska, United States
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Buffalo, New York, United States
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Cleveland, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Fairfax, Virginia, United States
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Edmonds, Washington, United States
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Seattle, Washington, United States
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Charleroi, , Belgium
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Ghent, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Avignon, , France
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Bobigny, , France
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Bordeaux, , France
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Limoges, , France
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Rennes, , France
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Rouen, , France
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Suresnes, , France
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Toulon, , France
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Kecskemét, , Hungary
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Székesfehérvár, , Hungary
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Tatabánya, , Hungary
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Törökbálint, , Hungary
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Aviano, , Italy
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Brescia, , Italy
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Catanzaro, , Italy
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Florence, , Italy
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Genova, , Italy
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Meldola, , Italy
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Milan, , Italy
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Monza, , Italy
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Padua, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Busan, , South Korea
Research Site
Chungcheongbuk-do, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
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Seoul, , South Korea
Research Site
Suwon, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Reus, , Spain
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Seville, , Spain
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Terrassa, , Spain
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Valencia, , Spain
Research Site
Liuying, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
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Taipei, , Taiwan
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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Cascone T, Bonanno L, Guisier F, Insa A, Liberman M, Bylicki O, Livi L, Egenod T, Corre R, Kim DW, Garcia Campelo MR, Provencio Pulla M, Shim BY, Metro G, Bennouna J, Bielska AA, Yohannes AR, He Y, Dowson A, Kar G, McGrath L, Kumar R, Grenga I, Spicer J, Forde PM. Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial. Nat Med. 2025 Aug;31(8):2788-2796. doi: 10.1038/s41591-025-03746-z. Epub 2025 May 31.
Related Links
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Lung Cancer Study Locator details (for US)
Other Identifiers
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D9077C00001
Identifier Type: -
Identifier Source: org_study_id
2023-508852-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-003369-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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