TrialPath
Recruiting

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

NCT05061550 · AstraZeneca
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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)
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 630 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-04-14
Estimated completion: 2030-05-28
Last updated: 2026-06-23
Interventions
Drug: DurvalumabDrug: OleclumabDrug: MonalizumabDrug: Dato-DXdDrug: AZD0171Drug: CarboplatinDrug: CisplatinDrug: Pemetrexed/CisplatinDrug: Pemetrexed/CarboplatinDrug: Carboplatin/PaclitaxelDrug: VolrustomigDrug: Rilvegostomig
Primary outcomes
  • 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))
Sponsor
AstraZeneca · industry
With: Parexel
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
ContactAstraZeneca Lung Cancer Study Locator Service · contact · az-lcsl@careboxhealth.com · 1-884-432-3892
InvestigatorTina Cascone, MD · principal_investigator, MD Anderson Cancer Center Houston, TX 77030
All locations (97)
Research SiteRecruiting
Little Rock, Arkansas, United States
Research SiteRecruiting
Los Angeles, California, United States
Research SiteWithdrawn
Oakland, California, United States
Research SiteRecruiting
New Haven, Connecticut, United States
Research SiteCompleted
Stuart, Florida, United States
Research SiteCompleted
Gainesville, Georgia, United States
Research SiteRecruiting
Chicago, Illinois, United States
Research SiteWithdrawn
Baltimore, Maryland, United States
Research SiteRecruiting
Baltimore, Maryland, United States
Research SiteRecruiting
Boston, Massachusetts, United States
Research SiteCompleted
Saint Louis Park, Minnesota, United States
Research SiteRecruiting
Omaha, Nebraska, United States
Research SiteRecruiting
Buffalo, New York, United States
Research SiteRecruiting
Cleveland, Ohio, United States
Research SiteRecruiting
Pittsburgh, Pennsylvania, United States
Research SiteRecruiting
Chattanooga, Tennessee, United States
Research SiteRecruiting
Memphis, Tennessee, United States
Research SiteWithdrawn
Nashville, Tennessee, United States
Research SiteRecruiting
Nashville, Tennessee, United States
Research SiteRecruiting
Nashville, Tennessee, United States
Research SiteRecruiting
Houston, Texas, United States
Research SiteRecruiting
Houston, Texas, United States
Research SiteRecruiting
Fairfax, Virginia, United States
Research SiteRecruiting
Edmonds, Washington, United States
Research SiteRecruiting
Seattle, Washington, United States
Research SiteRecruiting
Ghent, Belgium
Research SiteCompleted
Ghent, Belgium
Research SiteRecruiting
Roeselare, Belgium
Research SiteCompleted
Edmonton, Alberta, Canada
Research SiteRecruiting
Winnipeg, Manitoba, Canada
Research SiteRecruiting
Montreal, Quebec, Canada
Research SiteRecruiting
Montreal, Quebec, Canada
Research SiteRecruiting
Avignon, France
Research SiteWithdrawn
Bobigny, France
Research SiteRecruiting
Bordeaux, France
Research SiteRecruiting
Limoges, France
Research SiteRecruiting
Rennes, France
Research SiteRecruiting
Rouen, France
Research SiteRecruiting
Suresnes, France
Research SiteRecruiting
Toulon, France
Research SiteRecruiting
Kecskemét, Hungary
Research SiteRecruiting
Székesfehérvár, Hungary
Research SiteCompleted
Tatabánya, Hungary
Research SiteRecruiting
Törökbálint, Hungary
Research SiteRecruiting
Dublin, Ireland
Research SiteRecruiting
Dublin, Ireland
Research SiteRecruiting
Dublin, Ireland
Research SiteRecruiting
Galway, Ireland
Research SiteRecruiting
Aviano, Italy
Research SiteRecruiting
Brescia, Italy
Research SiteWithdrawn
Catanzaro, Italy
Research SiteRecruiting
Florence, Italy
Research SiteRecruiting
Genova, Italy
Research SiteRecruiting
Meldola, Italy
Research SiteRecruiting
Milan, Italy
Research SiteRecruiting
Monza, Italy
Research SiteRecruiting
Padova, Italy
Research SiteRecruiting
Perugia, Italy
Research SiteRecruiting
Pisa, Italy
Research SiteRecruiting
Roma, Italy
Research SiteRecruiting
Rozzano, Italy
Research SiteRecruiting
Lisbon, Portugal
Research SiteRecruiting
Lisbon, Portugal
Research SiteRecruiting
Lisbon, Portugal
Research SiteRecruiting
Lisbon, Portugal
Research SiteWithdrawn
Porto, Portugal
Research SiteCompleted
Porto, Portugal
Research SiteRecruiting
Porto, Portugal
Research SiteCompleted
Busan, South Korea
Research SiteWithdrawn
Chungcheongbuk-do, South Korea
Research SiteRecruiting
Seongnam-si, South Korea
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Suwon, South Korea
Research SiteRecruiting
Suwon, South Korea
Research SiteRecruiting
A Coruña, Spain
Research SiteRecruiting
Alicante, Spain
Research SiteRecruiting
Barcelona, Spain
Research SiteRecruiting
Barcelona, Spain
Research SiteRecruiting
Córdoba, Spain
Research SiteRecruiting
Madrid, Spain
Research SiteRecruiting
Majadahonda, Spain
Research SiteRecruiting
Málaga, Spain
Research SiteRecruiting
Reus, Spain
Research SiteRecruiting
Seville, Spain
Research SiteRecruiting
Terrassa, Spain
Research SiteRecruiting
Valencia, Spain
Research SiteRecruiting
Liuying, Taiwan
Research SiteRecruiting
New Taipei City, Taiwan
Research SiteRecruiting
Tainan, Taiwan
Research SiteRecruiting
Taipei, Taiwan
Research SiteRecruiting
Taipei, Taiwan
Research SiteRecruiting
Ankara, Turkey (Türkiye)
Research SiteRecruiting
Ankara, Turkey (Türkiye)
Research SiteRecruiting
Ankara, Turkey (Türkiye)
Research SiteRecruiting
Istanbul, Turkey (Türkiye)
Research SiteRecruiting
Izmir, Turkey (Türkiye)
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer · TrialPath