Lung Cancer Clinical Trial

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

Summary

The study is intended to assess the safety and efficacy of neoadjuvant Durvalumab in combination with chemotherapy and Oleclumab or Monalizumab and adjuvant treatment in participants with resectable, early-stage non-small cell lung cancer

View Full Description

Full Description

This is a open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.

Arm 1: Participants will receive Oleclumab + durvalumab + platinum doublet chemotherapy as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.

Arm 2: Participants will receive Monalizumab + durvalumab + platinum doublet chemotherapy as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.

Arm 3: Participants will receive MEDI5752 + platinum doublet chemotherapy as neoadjuvant treatment and MEDI5752 as adjuvant treatment.

View Eligibility Criteria

Eligibility Criteria

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.
History of allogeneic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders.
Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, 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.
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-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A and HLA-E agents are also excluded.
Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

210

Study ID:

NCT05061550

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 60 Locations for this study

See Locations Near You

Research Site
Stuart Florida, 34994, United States
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Gainesville Georgia, 30501, United States
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Baltimore Maryland, 21231, United States
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Boston Massachusetts, 02215, United States
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Saint Louis Park Minnesota, 55426, United States
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Cleveland Ohio, 44195, United States
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Pittsburgh Pennsylvania, 15212, United States
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Memphis Tennessee, 38120, United States
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Houston Texas, 77030, United States
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Fairfax Virginia, 22031, United States
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Edmonton Alberta, T6G 1, Canada
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Montreal Quebec, H2X 3, Canada
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Montréal Quebec, H2W 1, Canada
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Bordeaux Cedex , 33076, France
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Limoges , 83000, France
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Rennes Cedex , 35000, France
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Rouen , 76031, France
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Suresnes , 92150, France
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Toulon , 83000, France
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Aviano , 33081, Italy
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Brescia , 25123, Italy
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Catanzaro , 88100, Italy
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Firenze , 50134, Italy
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Genova , 16100, Italy
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Meldola , 47014, Italy
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Milano , 20162, Italy
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Monza , 20900, Italy
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Padova , 35128, Italy
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Perugia , 06156, Italy
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Pisa , 56124, Italy
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Roma , 00144, Italy
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Rozzano , 20089, Italy
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Busan , 48108, Korea, Republic of
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Chungcheongbuk-do , 28644, Korea, Republic of
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Seongnam-si , 13496, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Suwon , 16247, Korea, Republic of
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Lisboa , 1099-, Portugal
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Lisboa , 1400-, Portugal
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Lisboa , 1500-, Portugal
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Lisbon , 1169-, Portugal
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Porto , 4099-, Portugal
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Porto , 4100-, Portugal
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Porto , 4200-, Portugal
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Barcelona , 08035, Spain
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Barcelona , 08036, Spain
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Cordoba , 14004, Spain
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Coruña , 15006, Spain
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Madrid , 28040, Spain
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Madrid , 28040, Spain
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Majadahonda , 28250, Spain
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Malaga , 29010, Spain
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Reus,Tarragona , 43204, Spain
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Sevilla , 41009, Spain
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Terrassa , 08221, Spain
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Valencia , 46010, Spain
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Liuying , 736, Taiwan
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Tainan City , 70403, Taiwan
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Taipei , 10002, Taiwan
Research Site
Taipei , 11217, Taiwan
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Taipei , 235, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

210

Study ID:

NCT05061550

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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