Fact CheckerSign in

NCT05061550RecruitingPhase 2

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

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)

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
630 (estimated)
First submitted
20 Sept 2021
Start date
14 Apr 2022
Primary completion date
28 May 2030
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT05061550
EU CT number
2023-508852-21-00
EudraCT number
2021-003369-37

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 630
  • From 14 Apr 2022 to the primary completion date, 28 May 2030
  • 86 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active or prior documented autoimmune or inflammatory disorders.
  • 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.
  • Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
  • 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.

Other illness

  • 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 with moderate or severe cardiovascular disease.
  • Active or uncontrolled infections including HBA, HBV, HCV, and HIV.

Lab values

  • Participants with sensitising EGFR mutations or ALK translocations.
  • QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.

Other

  • Participants with baseline PD-L1 expression status \<1% (Arms 6 and 7 only).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (86)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Grand Hopital de Charleroi
Coordinator of this site? Confirm its status
CharleroiBelgiumRecruiting
Az Maria Middelares Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
AZ Sint-Lucas & Volkskliniek
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Algemeen Ziekenhuis Delta
Coordinator of this site? Confirm its status
RoeselareBelgiumRecruiting
Research Site
Coordinator of this site? Confirm its status
EdmontonCanadaCompleted
Research Site
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Research Site
Coordinator of this site? Confirm its status
WinnipegCanadaRecruiting
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainRecruiting
Hospital General Universitario Dr. Balmis
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Coordinator of this site? Confirm its status
MajadahondaSpainRecruiting
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Salut Sant Joan de Reus
Coordinator of this site? Confirm its status
ReusSpainRecruiting
Hospital Universitario Virgen De La Macarena
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Fundacio Assistencial De Mutua De Terrassa Fpc
Coordinator of this site? Confirm its status
TerrassaSpainRecruiting
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Centre Hospitalier d'Avignon
Coordinator of this site? Confirm its status
AvignonFranceRecruiting
Centre Hospitalier Universitaire De Bordeaux
Coordinator of this site? Confirm its status
Bordeaux CedexFranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
Coordinator of this site? Confirm its status
LimogesFranceRecruiting
Centre Hospitalier Intercommunal De Cornouaille
Coordinator of this site? Confirm its status
Quimper CedexFranceRecruiting
Centre Hospitalier Universitaire Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceRecruiting
Hospital Foch
Coordinator of this site? Confirm its status
SuresnesFranceRecruiting
HIA Sainte Anne
Coordinator of this site? Confirm its status
Toulon Cedex 9FranceRecruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
Coordinator of this site? Confirm its status
KecskemétHungaryRecruiting
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Coordinator of this site? Confirm its status
SzekesfehervarHungaryRecruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Coordinator of this site? Confirm its status
TatabányaHungaryRecruiting
Református Pulmonológiai Centrum
Coordinator of this site? Confirm its status
TörökbálintHungaryRecruiting
Mater Misericordiae University Hospital
Coordinator of this site? Confirm its status
Dublin 7IrelandRecruiting
St James's Hospital
Coordinator of this site? Confirm its status
Dublin 8IrelandRecruiting
Beaumont Hospital
Coordinator of this site? Confirm its status
Dublin 9IrelandRecruiting
University Hospital Galway
Coordinator of this site? Confirm its status
GalwayIrelandRecruiting
Centro di Riferimento Oncologico di Aviano
Coordinator of this site? Confirm its status
AvianoItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Careggi University Hospital
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
IRCCS Ospedale Policlinico San Martino
Coordinator of this site? Confirm its status
GenoaItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Coordinator of this site? Confirm its status
MeldolaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
Istituto Oncologico Veneto
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
University Hospital Of Perugia
Coordinator of this site? Confirm its status
PerugiaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyRecruiting
I.F.O. Istituti Fisioterapici Ospitalieri
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting
Research Site
Coordinator of this site? Confirm its status
BusanSouth KoreaCompleted
Research Site
Coordinator of this site? Confirm its status
Chungcheongbuk-doSouth KoreaWithdrawn
Research Site
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaRecruiting
Research Site
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Research Site
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting
Unidade Local De Saude De Sao Jose E.P.E.
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Hospital da Luz, S.A
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Champalimaud Clinical Centre
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
Research Site
Coordinator of this site? Confirm its status
LiuyingTaiwanRecruiting
Research Site
Coordinator of this site? Confirm its status
New Taipei CityTaiwanRecruiting
Research Site
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting
Research Site
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Research Site
Coordinator of this site? Confirm its status
BaltimoreUnited StatesWithdrawn
Research Site
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
BuffaloUnited StatesWithdrawn
Research Site
Coordinator of this site? Confirm its status
ChattanoogaUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
EdmondsUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
GainesvilleUnited StatesWithdrawn
Research Site
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
NashvilleUnited StatesWithdrawn
Research Site
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
OaklandUnited StatesWithdrawn
Research Site
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
Saint Louis ParkUnited StatesCompleted
Research Site
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Research Site
Coordinator of this site? Confirm its status
StuartUnited StatesCompleted
Research Site
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Research Site
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
Research Site
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.