Tests new combination treatments before surgery for early lung cancer
Tests drug combinations with chemotherapy before and after surgery in early lung cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
Key facts
- Where
- Lisbon and Porto, PortugalSee the 5 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 95 years old?
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT05061550, who can take part
Where in Portugal
- Champalimaud Clinical CentreLisbon, PortugalTaking people
- Hospital da Luz, S.ALisbon, PortugalTaking people
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Lisbon, PortugalTaking people
- Unidade Local De Saude De Sao Jose E.P.E.Lisbon, PortugalTaking people
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.Porto, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT05061550EU 2023-508852-21-00
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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; Participants with sensitising EGFR mutations or ALK translocations; QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms; Participants with baseline PD-L1 expression status <1% (Arms 6 and 7 only).