Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
NeoCOAST-2
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)
3 other identifiers
interventional
630
12 countries
99
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Apr 2022
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedStudy Start
First participant enrolled
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 28, 2030
March 11, 2026
March 1, 2026
8.1 years
September 20, 2021
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with pathological complete response (pCR)
From randomization to approximately 15 weeks after the first dose of study interventions
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Until Day 90 after the last dose of study interventions (Up to approximately 3 years)
Secondary Outcomes (10)
Number of participants experiencing an event-free survival (EFS) event
Up to approximately 3 years
Number of participants experiencing a disease-free survival (DFS) event
Up to approximately 3 years
Number of participants having surgical resection
From randomization to approximately 15 weeks after the first dose of study interventions
Number of participants with major pathological response (mPR)
From randomization to approximately 15 weeks after the first dose of study interventions
Number of participants with Objective response rate (ORR)
From randomization to approximately 15 weeks after the first dose of study interventions
- +5 more secondary outcomes
Study Arms (7)
Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
EXPERIMENTALParticipants 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
Arm 2: Monalizumab + Durvalumab + CTX
EXPERIMENTALParticipants 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
Arm 3: Volrustomig (Dose Exploration) + CTX
EXPERIMENTALParticipants 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
Arm 4: Dato-DXd + durvalumab + single agent platinum
EXPERIMENTALParticipants 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
Arm 5: AZD0171 + durvalumab + CTX
EXPERIMENTALParticipants 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
Arm 6: Rilvegostomig + CTX
EXPERIMENTALParticipants 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
Arm 7: Dato-DXd + Rilvegostomig + single agent platinum
EXPERIMENTALParticipants 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
Interventions
Participants will receive Durvalumab via intravenous route.
Participants will receive Oleclumab via intravenous route.
Participants will receive Monalizumab via intravenous route.
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
Participants will receive AZD0171 via intravenous route.
Carboplatin as chemotherapy
Cisplatin as chemotherapy
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel, as chemotherapy
Participants will receive Volrustomig via intravenous route.
Participants will receive Rilvegostomig via intravenous route.
Eligibility Criteria
You 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 may not qualify 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Parexelcollaborator
- AstraZenecalead
Study Sites (99)
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Oakland, California, 94611, United States
Research Site
New Haven, Connecticut, 06510, United States
Research Site
Stuart, Florida, 34994, United States
Research Site
Gainesville, Georgia, 30501, United States
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Chicago, Illinois, 60637, United States
Research Site
Baltimore, Maryland, 21201, United States
Research Site
Baltimore, Maryland, 21231, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Saint Louis Park, Minnesota, 55426, United States
Research Site
Omaha, Nebraska, 68124, United States
Research Site
Buffalo, New York, 14263, United States
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Cleveland, Ohio, 44195, United States
Research Site
Pittsburgh, Pennsylvania, 15212, United States
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Chattanooga, Tennessee, 37404, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Houston, Texas, 77030, United States
Research Site
Houston, Texas, 77090, United States
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Fairfax, Virginia, 22031, United States
Research Site
Edmonds, Washington, 98026, United States
Research Site
Seattle, Washington, 98104, United States
Research Site
Ghent, 9000, Belgium
Research Site
Ghent, 9000, Belgium
Research Site
Gilly, 6060, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Roeselare, 8800, Belgium
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Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Winnipeg, Manitoba, R3E 0V9, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Avignon, 84902, France
Research Site
Bobigny, 93009, France
Research Site
Bordeaux, 33076, France
Research Site
Limoges, 83000, France
Research Site
Rennes, 35000, France
Research Site
Rouen, 76031, France
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Suresnes, 92150, France
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Toulon, 83000, France
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Kecskemét, 6000, Hungary
Research Site
Székesfehérvár, 8000, Hungary
Research Site
Tatabánya, 2800, Hungary
Research Site
Törökbálint, 2045, Hungary
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Dublin, D07 R2WY, Ireland
Research Site
Dublin, D08 NHY1, Ireland
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Dublin, D09 V2N0, Ireland
Research Site
Galway, H91 YR71, Ireland
Research Site
Aviano, 33081, Italy
Research Site
Brescia, 25123, Italy
Research Site
Catanzaro, 88100, Italy
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Florence, 50134, Italy
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Genova, 16100, Italy
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Meldola, 47014, Italy
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Milan, 20162, Italy
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Monza, 20900, Italy
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Padua, 35128, Italy
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Perugia, 06156, Italy
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Pisa, 56124, Italy
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Roma, 00144, Italy
Research Site
Rozzano, 20089, Italy
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Lisbon, 1099-023, Portugal
Research Site
Lisbon, 1169-050, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1500-650, Portugal
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Porto, 4099-001, Portugal
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Porto, 4100-180, Portugal
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Porto, 4200-072, Portugal
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Busan, 48108, South Korea
Research Site
Chungcheongbuk-do, 28644, South Korea
Research Site
Seongnam-si, 13496, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Suwon, 16247, South Korea
Research Site
Suwon, 440-746, South Korea
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A Coruña, 15006, Spain
Research Site
Alicante, 03010, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Madrid, 28040, Spain
Research Site
Majadahonda, 28250, Spain
Research Site
Málaga, 29010, Spain
Research Site
Reus, 43204, Spain
Research Site
Seville, 41009, Spain
Research Site
Terrassa, 08221, Spain
Research Site
Valencia, 46010, Spain
Research Site
Liuying, 736, Taiwan
Research Site
New Taipei City, 235, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Ankara, 06010, Turkey (Türkiye)
Research Site
Ankara, 06500, Turkey (Türkiye)
Research Site
Ankara, 06800, Turkey (Türkiye)
Research Site
Istanbul, 34722, Turkey (Türkiye)
Research Site
Izmir, 35575, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 40450142DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tina Cascone, MD
MD Anderson Cancer Center Houston, TX 77030
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 29, 2021
Study Start
April 14, 2022
Primary Completion (Estimated)
May 28, 2030
Study Completion (Estimated)
May 28, 2030
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.