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 an 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 + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.

Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.

Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.

Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment.

Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab 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.
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 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-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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

490

Study ID:

NCT05061550

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 93 Locations for this study

See Locations Near You

Research Site
Little Rock Arkansas, 72205, United States
Research Site
Los Angeles California, 90095, United States
Research Site
Oakland California, 94611, United States
Research Site
New Haven Connecticut, 06510, United States
Research Site
Stuart Florida, 34994, United States
Research Site
Gainesville Georgia, 30501, United States
Research Site
Chicago Illinois, 60637, United States
Research Site
Baltimore Maryland, 21201, United States
Research Site
Baltimore Maryland, 21231, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
Saint Louis Park Minnesota, 55426, United States
Research Site
Buffalo New York, 14263, United States
Research Site
Cleveland Ohio, 44195, United States
Research Site
Pittsburgh Pennsylvania, 15212, United States
Research Site
Chattanooga Tennessee, 37404, United States
Research Site
Memphis Tennessee, 38120, United States
Research Site
Nashville Tennessee, 37203, United States
Research Site
Nashville Tennessee, 37232, United States
Research Site
Houston Texas, 77030, United States
Research Site
Houston Texas, 77090, United States
Research Site
Fairfax Virginia, 22031, United States
Research Site
Seattle Washington, 98104, United States
Research Site
Charleroi , 6000, Belgium
Research Site
Gent , 9000, Belgium
Research Site
Gent , 9000, Belgium
Research Site
Leuven , 3000, Belgium
Research Site
Roeselare , 8800, Belgium
Research Site
Edmonton Alberta, T6G 1, Canada
Research Site
Winnipeg Manitoba, R3E 0, Canada
Research Site
Montreal Quebec, H2X 3, Canada
Research Site
Montréal Quebec, H2W 1, Canada
Research Site
Avignon Cedex , 84902, France
Research Site
Bobigny , 93009, France
Research Site
Bordeaux Cedex , 33076, France
Research Site
Limoges , 83000, France
Research Site
Rennes Cedex , 35000, France
Research Site
Rouen , 76031, France
Research Site
Suresnes , 92150, France
Research Site
Toulon , 83000, France
Research Site
Kecskemét , 6000, Hungary
Research Site
Székesfehérvár , 8000, Hungary
Research Site
Tatabánya , 2800, Hungary
Research Site
Törökbálint , 2045, Hungary
Research Site
Dublin 7 , D07 R, Ireland
Research Site
Dublin 8 , D08 N, Ireland
Research Site
Dublin , D09 V, Ireland
Research Site
Galway , H91 Y, Ireland
Research Site
Aviano , 33081, Italy
Research Site
Brescia , 25123, Italy
Research Site
Catanzaro , 88100, Italy
Research Site
Firenze , 50134, Italy
Research Site
Genova , 16100, Italy
Research Site
Meldola , 47014, Italy
Research Site
Milano , 20162, Italy
Research Site
Monza , 20900, Italy
Research Site
Padova , 35128, Italy
Research Site
Perugia , 06156, Italy
Research Site
Pisa , 56124, Italy
Research Site
Roma , 00144, Italy
Research Site
Rozzano , 20089, Italy
Research Site
Busan , 48108, Korea, Republic of
Research Site
Chungcheongbuk-do , 28644, Korea, Republic of
Research Site
Seongnam-si , 13496, Korea, Republic of
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Suwon , 16247, Korea, Republic of
Research Site
Suwon , 440-7, Korea, Republic of
Research Site
Lisboa , 1099-, Portugal
Research Site
Lisboa , 1400-, Portugal
Research Site
Lisboa , 1500-, Portugal
Research Site
Lisbon , 1169-, Portugal
Research Site
Porto , 4099-, Portugal
Research Site
Porto , 4100-, Portugal
Research Site
Porto , 4200-, Portugal
Research Site
Alicante , 03010, Spain
Research Site
Barcelona , 08036, Spain
Research Site
Barcelona , 8035, Spain
Research Site
Cordoba , 14004, Spain
Research Site
Coruña , 15006, Spain
Research Site
Madrid , 28040, Spain
Research Site
Majadahonda , 28250, Spain
Research Site
Malaga , 29010, Spain
Research Site
Reus,Tarragona , 43204, Spain
Research Site
Sevilla , 41009, Spain
Research Site
Terrassa , 08221, Spain
Research Site
Valencia , 46010, Spain
Research Site
Liuying , 736, Taiwan
Research Site
Tainan City , 70403, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Taipei , 11217, Taiwan
Research Site
Taipei , 235, Taiwan
Research Site
Ankara , 06010, Turkey
Research Site
Ankara , 06500, Turkey
Research Site
Ankara , 06800, Turkey
Research Site
Istanbul , 34722, Turkey
Research Site
Izmir , 35575, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

490

Study ID:

NCT05061550

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.