Lung Cancer Clinical Trial
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
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
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.
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.
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.
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There are 60 Locations for this study
Stuart Florida, 34994, United States
Gainesville Georgia, 30501, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Saint Louis Park Minnesota, 55426, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15212, United States
Memphis Tennessee, 38120, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Edmonton Alberta, T6G 1, Canada
Montreal Quebec, H2X 3, Canada
Montréal Quebec, H2W 1, Canada
Bordeaux Cedex , 33076, France
Limoges , 83000, France
Rennes Cedex , 35000, France
Rouen , 76031, France
Suresnes , 92150, France
Toulon , 83000, France
Aviano , 33081, Italy
Brescia , 25123, Italy
Catanzaro , 88100, Italy
Firenze , 50134, Italy
Genova , 16100, Italy
Meldola , 47014, Italy
Milano , 20162, Italy
Monza , 20900, Italy
Padova , 35128, Italy
Perugia , 06156, Italy
Pisa , 56124, Italy
Roma , 00144, Italy
Rozzano , 20089, Italy
Busan , 48108, Korea, Republic of
Chungcheongbuk-do , 28644, Korea, Republic of
Seongnam-si , 13496, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Suwon , 16247, Korea, Republic of
Lisboa , 1099-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1500-, Portugal
Lisbon , 1169-, Portugal
Porto , 4099-, Portugal
Porto , 4100-, Portugal
Porto , 4200-, Portugal
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Cordoba , 14004, Spain
Coruña , 15006, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Majadahonda , 28250, Spain
Malaga , 29010, Spain
Reus,Tarragona , 43204, Spain
Sevilla , 41009, Spain
Terrassa , 08221, Spain
Valencia , 46010, Spain
Liuying , 736, Taiwan
Tainan City , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taipei , 235, Taiwan
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