Comparing 7 approaches for non-small cell lung cancer
Official title: 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)
Interventions
Durvalumab
Participants will receive Durvalumab via intravenous route.
Oleclumab
Participants will receive Oleclumab via intravenous route.
Monalizumab
Participants will receive Monalizumab via intravenous route.
Dato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
AZD0171
Participants will receive AZD0171 via intravenous route.
Carboplatin
Carboplatin as chemotherapy
Cisplatin
Cisplatin as chemotherapy
Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy
Volrustomig
Participants will receive Volrustomig via intravenous route.
Rilvegostomig
Participants will receive Rilvegostomig via intravenous route.
Canadian Sites (4)
Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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
- −Participants with sensitising EGFR mutations or ALK translocations.
- −Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
- −Participants with baselineBaselineYour starting measurements, taken before treatment begins.Read more → PD-L1 expression status \<1% (ArmsArmOne of the groups in a study, each receiving something different.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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.
- −Participants with moderate or severe cardiovascular disease.
- −Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- −Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
- −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.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Durvalumab, Oleclumab, Monalizumab, Dato-DXd, and 8 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 7 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 95 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 630 people.
The study is currently expected to finish around May 2030.
The main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to approximately 15 weeks after the first dose of study interventions.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with pathological complete response (pCR) — measured over From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to approximately 15 weeks after the first dose of study interventions.
Number of participants with adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) and serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) — measured over Until Day 90 after the last dose of study interventions (Up to approximately 3 years).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05061550 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About DurvalumabDrug
Participants will receive Durvalumab via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OleclumabDrug
Participants will receive Oleclumab via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About MonalizumabDrug
Participants will receive Monalizumab via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Dato-DXdDrug
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AZD0171Drug
Participants will receive AZD0171 via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarboplatinDrug
Carboplatin as chemotherapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CisplatinDrug
Cisplatin as chemotherapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Pemetrexed/CisplatinDrug
Pemetrexed/Cisplatin as chemotherapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Pemetrexed/CarboplatinDrug
Pemetrexed/Carboplatin as chemotherapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Carboplatin/PaclitaxelDrug
Carboplatin/Paclitaxel, as chemotherapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About VolrustomigDrug
Participants will receive Volrustomig via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RilvegostomigDrug
Participants will receive Rilvegostomig via intravenous route.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 95 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 95 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to approximately 15 weeks after the first dose of study interventions.
The study as a whole is currently expected to finish around 2030-05-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 630 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Montreal, Quebec, Canada; Saint Louis Park, Minnesota, United States; Buffalo, New York, United States; Edmonds, Washington, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (4)
Research Site
Saint Louis Park, Minnesota, United States
Research Site
Buffalo, New York, United States
Research Site
Edmonds, Washington, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.