What this study is
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.
What's being tested
- Durvalumab
Intervention · DRUG
Participants will receive Durvalumab via intravenous route.
- Oleclumab
Intervention · DRUG
Participants will receive Oleclumab via intravenous route.
- Monalizumab
Intervention · DRUG
Participants will receive Monalizumab via intravenous route.
- Dato-DXd
Intervention · DRUG
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
- AZD0171
Intervention · DRUG
Participants will receive AZD0171 via intravenous route.
- Carboplatin
Intervention · DRUG
Carboplatin as chemotherapy
- Cisplatin
Intervention · DRUG
Cisplatin as chemotherapy
- Pemetrexed/Cisplatin
Intervention · DRUG
Pemetrexed/Cisplatin as chemotherapy
- Pemetrexed/Carboplatin
Intervention · DRUG
Pemetrexed/Carboplatin as chemotherapy
- Carboplatin/Paclitaxel
Intervention · DRUG
Carboplatin/Paclitaxel, as chemotherapy
- Volrustomig
Intervention · DRUG
Participants will receive Volrustomig via intravenous route.
- Rilvegostomig
Intervention · DRUG
Participants will receive Rilvegostomig via intravenous route.
Study details
- Official title
- A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)
- Sponsor
- AstraZeneca
- Conditions
- Non-small Cell Lung Cancer
- Enrolling
- 630 people
- Starts
- 2022-04-14
- Est. completion
- 2030-05-28
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 95 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (97)
78 openResearch Site
Little Rock, Arkansas, United States
RecruitingResearch Site
Los Angeles, California, United States
RecruitingResearch Site
New Haven, Connecticut, United States
RecruitingResearch Site
Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Omaha, Nebraska, 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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Houston, Texas, United States
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Fairfax, Virginia, United States
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Edmonds, Washington, United States
RecruitingResearch Site
Seattle, Washington, United States
RecruitingResearch Site
Oakland, California, United States
WithdrawnResearch Site
Stuart, Florida, United States
CompletedResearch Site
Gainesville, Georgia, United States
WithdrawnResearch Site
Baltimore, Maryland, United States
WithdrawnResearch Site
Saint Louis Park, Minnesota, United States
CompletedResearch Site
Buffalo, New York, United States
WithdrawnResearch Site
Nashville, Tennessee, United States
WithdrawnResearch Site
Houston, Texas, United States
Terminated
72 sites outside the US
Research Site
Ghent, Belgium
RecruitingResearch Site
Roeselare, Belgium
RecruitingResearch Site
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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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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Kecskemét, Hungary
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Székesfehérvár, 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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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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Padova, 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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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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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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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
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Liuying, Taiwan
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New Taipei City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
RecruitingResearch Site
Ghent, Belgium
CompletedResearch Site
Edmonton, Alberta, Canada
CompletedResearch Site
Bobigny, France
WithdrawnResearch Site
Toulon, France
Active, not recruitingResearch Site
Tatabánya, Hungary
CompletedResearch Site
Catanzaro, Italy
WithdrawnResearch Site
Porto, Portugal
WithdrawnResearch Site
Porto, Portugal
CompletedResearch Site
Busan, South Korea
CompletedResearch Site
Chungcheongbuk-do, South Korea
WithdrawnResearch Site
Barcelona, Spain
Terminated
Study team
Sponsor
AstraZeneca
Study ID D9077C00001
Principal investigator
Tina Cascone, MD
MD Anderson Cancer Center Houston, TX 77030
CONTACT
AstraZeneca Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.