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Clinical Trials in the USA / NCT05061550
Recruiting Phase 2

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

NCT05061550 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2022-04-14
Last updated
2026-08-21

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

DurvalumabOleclumabMonalizumabDato-DXdAZD0171CarboplatinCisplatinPemetrexed/CisplatinPemetrexed/CarboplatinCarboplatin/PaclitaxelVolrustomigRilvegostomig

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
95 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (97)

FacilityCityRegionStatus
Research Site Little Rock Arkansas Recruiting
Research Site Los Angeles California Recruiting
Research Site Oakland California Withdrawn
Research Site New Haven Connecticut Recruiting
Research Site Stuart Florida Completed
Research Site Gainesville Georgia Completed
Research Site Chicago Illinois Recruiting
Research Site Baltimore Maryland Withdrawn
Research Site Baltimore Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Saint Louis Park Minnesota Completed
Research Site Omaha Nebraska Recruiting
Research Site Buffalo New York Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Chattanooga Tennessee Recruiting
Research Site Memphis Tennessee Recruiting
Research Site Nashville Tennessee Withdrawn
Research Site Nashville Tennessee Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Houston Texas Recruiting
Research Site Houston Texas Recruiting
Research Site Fairfax Virginia Recruiting
Research Site Edmonds Washington Recruiting
Research Site Seattle Washington Recruiting
Research Site Ghent Belgium Recruiting
Research Site Ghent Belgium Completed
Research Site Roeselare Belgium Recruiting
Research Site Edmonton Alberta Completed
Research Site Winnipeg Manitoba Recruiting
Research Site Montreal Quebec Recruiting
Research Site Montreal Quebec Recruiting
Research Site Avignon France Recruiting
Research Site Bobigny France Withdrawn
Research Site Bordeaux France Recruiting
Research Site Limoges France Recruiting
Research Site Rennes France Recruiting
Research Site Rouen France Recruiting
Research Site Suresnes France Recruiting
Research Site Toulon France Recruiting

+ 57 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05061550 on ClinicalTrials.gov ↗ ← All trials in the USA