Actively Recruiting

Phase 2
Age: 18Years - 95Years
All Genders
NCT05061550

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

Led by AstraZeneca · Updated on 2026-03-11

630

Participants Needed

99

Research Sites

423 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

P

Parexel

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
  • WHO or ECOG performance status of 0 or 1.
  • Adequate organ and bone marrow function.
  • Provision of tumor samples (newly acquired or archival tumor tissue ≤ 6 months old) to confirm PD-L1, EGFR, or ALK status.
  • Adequate pulmonary function.
Not Eligible

You will not qualify if you...

  • Sensitising EGFR mutations or ALK translocations.
  • Baseline PD-L1 expression status <1% (Arms 6 and 7 only).
  • Active or prior autoimmune or inflammatory disorders.
  • Uncontrolled illnesses including hypertension, angina, arrhythmia, bleeding, serious gastrointestinal conditions, psychiatric illness, or social situations limiting compliance.
  • History of another primary malignancy.
  • Small-cell lung cancer or mixed small-cell lung cancer.
  • History of active primary immunodeficiency.
  • History or current non-infectious interstitial lung disease or pneumonitis requiring steroids.
  • Preoperative radiotherapy planned.
  • Need for pneumonectomy, segmentectomies, or wedge resections to achieve curative tumor removal.
  • QTcF interval ≥ 470 ms.
  • Medical contraindications to chemotherapy.
  • Moderate or severe cardiovascular disease.
  • Concurrent cancer chemotherapy, investigational, biologic, or hormonal therapy.
  • Receipt of live attenuated vaccine within 30 days prior to first study dose.
  • Prior exposure to immune-mediated therapies including anti-CTLA-4, anti-TIGIT, anti-PD-1, anti-PD-L1, anti-PD-L2, adenosine pathway agents, anti-NKG2A, anti-HLA-E, anti-LIF, TROP2 targeting ADCs, or other ADCs with TOP1 inhibitors.
  • Use of immunosuppressive medication within 14 days before first study dose.
  • Active or uncontrolled infections including HBA, HBV, HCV, and HIV.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 99 locations

1

Research Site

Little Rock, Arkansas, United States, 72205

Actively Recruiting

2

Research Site

Los Angeles, California, United States, 90095

Actively Recruiting

3

Research Site

Oakland, California, United States, 94611

Withdrawn

4

Research Site

New Haven, Connecticut, United States, 06510

Actively Recruiting

5

Research Site

Stuart, Florida, United States, 34994

Completed

6

Research Site

Gainesville, Georgia, United States, 30501

Completed

7

Research Site

Chicago, Illinois, United States, 60637

Actively Recruiting

8

Research Site

Baltimore, Maryland, United States, 21201

Withdrawn

9

Research Site

Baltimore, Maryland, United States, 21231

Actively Recruiting

10

Research Site

Boston, Massachusetts, United States, 02215

Actively Recruiting

11

Research Site

Saint Louis Park, Minnesota, United States, 55426

Completed

12

Research Site

Omaha, Nebraska, United States, 68124

Actively Recruiting

13

Research Site

Buffalo, New York, United States, 14263

Actively Recruiting

14

Research Site

Cleveland, Ohio, United States, 44195

Actively Recruiting

15

Research Site

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

16

Research Site

Chattanooga, Tennessee, United States, 37404

Actively Recruiting

17

Research Site

Memphis, Tennessee, United States, 38120

Actively Recruiting

18

Research Site

Nashville, Tennessee, United States, 37203

Withdrawn

19

Research Site

Nashville, Tennessee, United States, 37203

Actively Recruiting

20

Research Site

Nashville, Tennessee, United States, 37232

Actively Recruiting

21

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

22

Research Site

Houston, Texas, United States, 77090

Actively Recruiting

23

Research Site

Fairfax, Virginia, United States, 22031

Actively Recruiting

24

Research Site

Edmonds, Washington, United States, 98026

Actively Recruiting

25

Research Site

Seattle, Washington, United States, 98104

Actively Recruiting

26

Research Site

Ghent, Belgium, 9000

Actively Recruiting

27

Research Site

Ghent, Belgium, 9000

Completed

28

Research Site

Gilly, Belgium, 6060

Actively Recruiting

29

Research Site

Leuven, Belgium, 3000

Actively Recruiting

30

Research Site

Roeselare, Belgium, 8800

Actively Recruiting

31

Research Site

Edmonton, Alberta, Canada, T6G 1Z2

Completed

32

Research Site

Winnipeg, Manitoba, Canada, R3E 0V9

Actively Recruiting

33

Research Site

Montreal, Quebec, Canada, H2W 1S6

Actively Recruiting

34

Research Site

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

35

Research Site

Avignon, France, 84902

Actively Recruiting

36

Research Site

Bobigny, France, 93009

Withdrawn

37

Research Site

Bordeaux, France, 33076

Actively Recruiting

38

Research Site

Limoges, France, 83000

Actively Recruiting

39

Research Site

Rennes, France, 35000

Actively Recruiting

40

Research Site

Rouen, France, 76031

Actively Recruiting

41

Research Site

Suresnes, France, 92150

Actively Recruiting

42

Research Site

Toulon, France, 83000

Actively Recruiting

43

Research Site

Kecskemét, Hungary, 6000

Actively Recruiting

44

Research Site

Székesfehérvár, Hungary, 8000

Actively Recruiting

45

Research Site

Tatabánya, Hungary, 2800

Completed

46

Research Site

Törökbálint, Hungary, 2045

Actively Recruiting

47

Research Site

Dublin, Ireland, D07 R2WY

Actively Recruiting

48

Research Site

Dublin, Ireland, D08 NHY1

Actively Recruiting

49

Research Site

Dublin, Ireland, D09 V2N0

Actively Recruiting

50

Research Site

Galway, Ireland, H91 YR71

Actively Recruiting

51

Research Site

Aviano, Italy, 33081

Actively Recruiting

52

Research Site

Brescia, Italy, 25123

Actively Recruiting

53

Research Site

Catanzaro, Italy, 88100

Withdrawn

54

Research Site

Florence, Italy, 50134

Actively Recruiting

55

Research Site

Genova, Italy, 16100

Actively Recruiting

56

Research Site

Meldola, Italy, 47014

Actively Recruiting

57

Research Site

Milan, Italy, 20162

Actively Recruiting

58

Research Site

Monza, Italy, 20900

Actively Recruiting

59

Research Site

Padova, Italy, 35128

Actively Recruiting

60

Research Site

Perugia, Italy, 06156

Actively Recruiting

61

Research Site

Pisa, Italy, 56124

Actively Recruiting

62

Research Site

Roma, Italy, 00144

Actively Recruiting

63

Research Site

Rozzano, Italy, 20089

Actively Recruiting

64

Research Site

Lisbon, Portugal, 1099-023

Actively Recruiting

65

Research Site

Lisbon, Portugal, 1169-050

Actively Recruiting

66

Research Site

Lisbon, Portugal, 1400-038

Actively Recruiting

67

Research Site

Lisbon, Portugal, 1500-650

Actively Recruiting

68

Research Site

Porto, Portugal, 4099-001

Withdrawn

69

Research Site

Porto, Portugal, 4100-180

Completed

70

Research Site

Porto, Portugal, 4200-072

Actively Recruiting

71

Research Site

Busan, South Korea, 48108

Completed

72

Research Site

Chungcheongbuk-do, South Korea, 28644

Withdrawn

73

Research Site

Seongnam-si, South Korea, 13496

Actively Recruiting

74

Research Site

Seoul, South Korea, 03080

Actively Recruiting

75

Research Site

Seoul, South Korea, 05505

Actively Recruiting

76

Research Site

Suwon, South Korea, 16247

Actively Recruiting

77

Research Site

Suwon, South Korea, 440-746

Actively Recruiting

78

Research Site

A Coruña, Spain, 15006

Actively Recruiting

79

Research Site

Alicante, Spain, 03010

Actively Recruiting

80

Research Site

Barcelona, Spain, 08036

Actively Recruiting

81

Research Site

Barcelona, Spain, 8035

Actively Recruiting

82

Research Site

Córdoba, Spain, 14004

Actively Recruiting

83

Research Site

Madrid, Spain, 28040

Actively Recruiting

84

Research Site

Majadahonda, Spain, 28250

Actively Recruiting

85

Research Site

Málaga, Spain, 29010

Actively Recruiting

86

Research Site

Reus, Spain, 43204

Actively Recruiting

87

Research Site

Seville, Spain, 41009

Actively Recruiting

88

Research Site

Terrassa, Spain, 08221

Actively Recruiting

89

Research Site

Valencia, Spain, 46010

Actively Recruiting

90

Research Site

Liuying, Taiwan, 736

Actively Recruiting

91

Research Site

New Taipei City, Taiwan, 235

Actively Recruiting

92

Research Site

Tainan, Taiwan, 70403

Actively Recruiting

93

Research Site

Taipei, Taiwan, 10002

Actively Recruiting

94

Research Site

Taipei, Taiwan, 11217

Actively Recruiting

95

Research Site

Ankara, Turkey (Türkiye), 06010

Actively Recruiting

96

Research Site

Ankara, Turkey (Türkiye), 06500

Actively Recruiting

97

Research Site

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

98

Research Site

Istanbul, Turkey (Türkiye), 34722

Actively Recruiting

99

Research Site

Izmir, Turkey (Türkiye), 35575

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

A

AstraZeneca Lung Cancer Study Locator Service

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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