Study of New Treatments for Resectable Non-Small Cell Lung Cancer
This study is testing several new treatment combinations for people with newly diagnosed, resectable (meaning it can be removed by surgery) non-small cell lung cancer (NSCLC) that is Stage IIA to IIIB. You would receive treatments like Durvalumab, Oleclumab, Monalizumab, Dato-DXd, or AZD0171, often combined with chemotherapy, before and after surgery. Researchers want to see how many participants have a complete response to treatment (pathological complete response, or pCR) and to understand the safety of these new combinations. To join, you need to be between 18 and 95 years old, have good overall health, and provide tumor samples to check for specific markers like PD-L1.
- Study design
- This is an open-label, multi-arm, multi-center, randomized study, meaning you would be assigned by chance to one of several treatment groups, and both you and your doctors would know which treatment you are receiving. The study plans to enroll 630 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health and any side effects will be monitored until 90 days after your last study treatment, which could be up to approximately 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05061550
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
Recruiting
PHASE2Ages 18–95InterventionalTreatmentAstraZeneca
~630 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:DurvalumabOleclumabMonalizumabDato-DXdAZD0171Carboplatin
At a glance
Recruiting sites
82 of 97 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with pathological complete response (pCR)
Measured over From randomization to approximately 15 weeks after the first dose of study interventions
+1 more outcome measured
Conditions
Where it's being run
97 sites across 30 statesItaly13
Spain12
France8
Portugal7
South Korea7
Tennessee5
Taiwan5
Turkey (Türkiye)5
Study leadership
- Tina Cascone, MD · PRINCIPAL_INVESTIGATOR · MD Anderson Cancer Center Houston, TX 77030
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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.
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.
What this trial measures
- 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)