Tests new combination treatments before surgery for early lung cancer
Tests drug combinations with chemotherapy before and after surgery in early lung cancer.
Key facts
- Who runs it
- AstraZeneca
- Where
- Liuying, New Taipei City, Tainan, and Taipei, TaiwanSee the 4 sitesAlso in 11 other countries, 82 sites
- Trial code
- NCT05061550
- EU 2023-508852-21-00
- EudraCT 2021-003369-37
- U1111-1307-4238
- Registry title
- Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 630 people, planned
- Started
- 14 Apr 2022
- Expected to end
- 28 May 2030
- Type of study
- Interventional, 7 groups
- Treatments tested
- Durvalumab
- Oleclumab
- Monalizumab
- Dato-DXd
- AZD0171
- Carboplatin
- Cisplatin
- Pemetrexed/Cisplatin
- Pemetrexed/Carboplatin
- Carboplatin/Paclitaxel
- Volrustomig
- Rilvegostomig
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed non-small cell lung cancer that can be removed by surgery (stage IIA to IIIB). They get treatment before and after surgery.
- Age
- 18 to 95 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed non-small cell lung cancer that can be removed by surgery, stage IIA to IIIB.
- Earlier treatment
- People cannot have had earlier immune-mediated therapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies, or a TROP2-targeting ADC. Any other cancer treatment at the same time is also not allowed.
- Biomarker or test result
- Tumour samples are needed to check PD-L1, EGFR and ALK status. For Arms 6 and 7 only, PD-L1 must be 1% or higher.
Main reasons for not taking part
- Sensitising EGFR mutations or ALK translocations
- Small-cell or mixed small-cell lung cancer
- Active or past autoimmune or inflammatory disorders
- History of another primary cancer
- Active or uncontrolled infections, including HBV, HCV and HIV
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Check if you might fit
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?
Where in Taiwan
Also in 11 other countries, 82 sites
- LiuyingHospital not named in the registryContact: AstraZeneca Lung Cancer Study Locator ServiceTaking people
- New Taipei CityHospital not named in the registryContact: AstraZeneca Lung Cancer Study Locator ServiceTaking people
- TainanHospital not named in the registryContact: AstraZeneca Lung Cancer Study Locator ServiceTaking people
- TaipeiHospital not named in the registryContact: AstraZeneca Lung Cancer Study Locator ServiceTaking people
About the trial
What the trial wants to find out
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.
The 7 groups in the trial
- Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)Treatment being tested
Participants 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
Treatment: Durvalumab, Oleclumab, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin, and Carboplatin/Paclitaxel
- Arm 2: Monalizumab + Durvalumab + CTXTreatment being tested
Participants 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
Treatment: Durvalumab, Monalizumab, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin, and Carboplatin/Paclitaxel
- Arm 3: Volrustomig (Dose Exploration) + CTXTreatment being tested
Participants 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
Treatment: Pemetrexed/Cisplatin, Pemetrexed/Carboplatin, Carboplatin/Paclitaxel, and Volrustomig
- Arm 4: Dato-DXd + durvalumab + single agent platinumTreatment being tested
Participants 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
Treatment: Durvalumab, Dato-DXd, Carboplatin, and Cisplatin
- Arm 5: AZD0171 + durvalumab + CTXTreatment being tested
Participants 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
Treatment: Durvalumab, AZD0171, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin, and Carboplatin/Paclitaxel
- Arm 6: Rilvegostomig + CTXTreatment being tested
Participants 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
Treatment: Pemetrexed/Cisplatin, Pemetrexed/Carboplatin, Carboplatin/Paclitaxel, and Rilvegostomig
- Arm 7: Dato-DXd + Rilvegostomig + single agent platinumTreatment being tested
Participants 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
Treatment: Dato-DXd, Carboplatin, Cisplatin, and Rilvegostomig
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Tests new combination treatments before surgery for early lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05061550, who can take part
- Record updated
- 21 October 2026