Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05633667

Study of Novel Treatment Combinations in Patients With Lung Cancer

Led by Gilead Sciences · Updated on 2026-03-17

270

Participants Needed

100

Research Sites

337 weeks

Total Duration

On this page

Sponsors

G

Gilead Sciences

Lead Sponsor

A

Arcus Biosciences, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.

CONDITIONS

Official Title

Study of Novel Treatment Combinations in Patients With Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with non-small-cell lung cancer (NSCLC) confirmed by tissue or cell examination
  • No known genomic changes treatable with targeted therapies
  • ECOG performance status of 0 or 1
  • Measurable disease based on tumor response criteria
  • Adequate blood and organ function
  • Use contraception if capable of pregnancy and sexually active
  • For Substudy 01: Stage IV NSCLC, EGFR and ALK negative if nonsquamous, PD-L1 status confirmed, no prior systemic treatment for metastatic NSCLC
  • For Substudy 02: Stage IV NSCLC, treated with at least one targeted therapy if nonsquamous with genomic alterations
  • For Substudy 03: Resectable Stage II, IIIA, or IIIB NSCLC planned for lobectomy, sleeve lobectomy, or bi-lobectomy, EGFR and ALK negative if nonsquamous, PD-L1 status confirmed
Not Eligible

You will not qualify if you...

  • Mixed small-cell lung cancer and NSCLC histology
  • Presence of an active second cancer
  • Active autoimmune disease
  • History or current non-infectious pneumonitis or interstitial lung disease
  • Serious infection within 4 weeks before treatment
  • For Substudy 01 and 02: Active brain metastases or carcinomatous meningitis, anticancer therapy within 4 weeks before enrollment
  • For Substudy 03: Previous systemic therapy or radiotherapy for NSCLC, prior treatment with anti-PD-(L)-1 or immune checkpoint inhibitors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 100 locations

1

Arizona Oncology Associates,Substudy-01

Tucson, Arizona, United States, 85711

Withdrawn

2

Arizona Oncology Associates,Substudy-02

Tucson, Arizona, United States, 85711

Completed

3

Rocky Mountain Cancer Center,Substudy-01

Denver, Colorado, United States, 80218

Withdrawn

4

Rocky Mountain Cancer Center,Substudy-02

Denver, Colorado, United States, 80218

Withdrawn

5

Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03

Fort Wayne, Indiana, United States, 46845

Actively Recruiting

6

Baptist Health Lexington,Substudy-03

Lexington, Kentucky, United States, 40503

Actively Recruiting

7

Washington University School of Medicine - Siteman Cancer Center,Substudy-01

St Louis, Missouri, United States, 63110

Active, Not Recruiting

8

Washington University School of Medicine - Siteman Cancer Center,Substudy-02

St Louis, Missouri, United States, 63110

Active, Not Recruiting

9

Washington University School of Medicine - Siteman Cancer Center,Substudy-03

St Louis, Missouri, United States, 63110

Actively Recruiting

10

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States, 63110

Actively Recruiting

11

Oncology Hematology Care Clinical Trials, LLC,Substudy-01

Cincinnati, Ohio, United States, 45242

Active, Not Recruiting

12

Oncology Hematology Care Clinical Trials, LLC,Substudy-02

Cincinnati, Ohio, United States, 45242

Active, Not Recruiting

13

Oncology Associates of Oregon, PC,Substudy-01

Eugene, Oregon, United States, 97401

Completed

14

Oncology Associates of Oregon, PC,Substudy-02

Eugene, Oregon, United States, 97401

Active, Not Recruiting

15

Texas Oncology - Central South,Substudy-01

Austin, Texas, United States, 78745

Withdrawn

16

Texas Oncology - Central South,Substudy-02

Austin, Texas, United States, 78745

Withdrawn

17

US Oncology Investigational Products Center (IPC),Substudy-01

Fairfax, Virginia, United States, 22031

Withdrawn

18

US Oncology Investigational Products Center (IPC),Substudy-02

Fairfax, Virginia, United States, 22031

Withdrawn

19

Fred Hutchinson Cancer Center,Substudy-01

Seattle, Washington, United States, 98109

Withdrawn

20

Fred Hutchinson Cancer Center,Substudy-02

Seattle, Washington, United States, 98109

Withdrawn

21

Fundação Pio XII - Hospital de Amor,Substudy-01

Barretos, Brazil, 14784-400

Actively Recruiting

22

Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03

Porto Alegre, Brazil, 90110-270

Actively Recruiting

23

Hospital Mae de Deus,Substudy-01

Porto Alegre, Brazil, 90110-270

Actively Recruiting

24

Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

Actively Recruiting

25

Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01

Porto Alegre, Brazil, 90610001

Actively Recruiting

26

Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03

Porto Alegre, Brazil, 90610001

Actively Recruiting

27

BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01

São Paulo, Brazil, 1509

Actively Recruiting

28

Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01

São Paulo, Brazil, 1509

Actively Recruiting

29

Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03

São Paulo, Brazil, 1509

Actively Recruiting

30

Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03

São Paulo, Brazil, 1509

Actively Recruiting

31

Queen Mary Hospital,Substudy-01

Hong Kong, Hong Kong, 999077

Actively Recruiting

32

Queen Mary Hospital,Substudy-02

Hong Kong, Hong Kong, 999077

Active, Not Recruiting

33

Queen Elizabeth Hospital,Substudy-01

Hong Kong, Hong Kong

Actively Recruiting

34

Queen Elizabeth Hospital,Substudy-02

Hong Kong, Hong Kong

Active, Not Recruiting

35

Prince of Wales Hospital,Substudy-01

New Territories, Hong Kong

Actively Recruiting

36

Prince of Wales Hospital,Substudy-02

New Territories, Hong Kong

Active, Not Recruiting

37

Rambam Health Care Campus,Substudy-01

Haifa, Israel, 3525408

Actively Recruiting

38

Rambam Health Care Campus,Substudy-02

Haifa, Israel, 3525408

Active, Not Recruiting

39

Rambam Health Care Campus,Substudy-03

Haifa, Israel, 3525408

Actively Recruiting

40

Shaare Zedek Medical Center,Substudy-01

Jerusalem, Israel, 9103102

Actively Recruiting

41

Shaare Zedek Medical Center,Substudy-02

Jerusalem, Israel, 9103102

Active, Not Recruiting

42

Shaare Zedek Medical Center,Substudy-03

Jerusalem, Israel, 9103102

Actively Recruiting

43

Hadassah Medical Center,Substudy-01

Jerusalem, Israel, 91120

Actively Recruiting

44

Hadassah University Medical Center,Substudy-03

Jerusalem, Israel, 91120

Actively Recruiting

45

Rabin Medical Center,Substudy-03

Petah Tikva, Israel, 49100

Withdrawn

46

Tel Aviv Sourasky Medical Center,Substudy-01

Tel Aviv, Israel, 64239

Actively Recruiting

47

Tel Aviv Sourasky Medical Center,Substudy-02

Tel Aviv, Israel, 64239

Active, Not Recruiting

48

Tel-Aviv Sourasky Medical Center,Substudy-03

Tel Aviv, Israel, 64239

Actively Recruiting

49

Chungbuk National University Hospital,Substudy-01

Cheongju-si, South Korea, 28644

Active, Not Recruiting

50

Chungbuk National University Hospital,Substudy-02

Cheongju-si, South Korea, 28644

Active, Not Recruiting

51

National Cancer Center,Substudy-01

Goyang, South Korea, 410769

Actively Recruiting

52

National Cancer Center,Substudy-02

Goyang, South Korea, 410769

Active, Not Recruiting

53

National Cancer Center,Substudy-03

Goyang, South Korea, 410769

Actively Recruiting

54

Chonnam National University Hwasun Hospital,Substudy-01

Gwangju, South Korea, 61469

Actively Recruiting

55

Chonnam National University Hwasun Hospital,Substudy-03

Gwangju, South Korea, 61469

Actively Recruiting

56

Seoul National University Bundang Hospital,Substudy-01

Gyeonggi-do, South Korea, 463-707

Actively Recruiting

57

Seoul National University Bundang Hospital,Substudy-03

Gyeonggi-do, South Korea, 463-707

Actively Recruiting

58

Kosin University Gospel Hospital,Substudy-01

Seogu, South Korea, 49267

Active, Not Recruiting

59

Kosin University Gospel Hospital,Substudy-03

Seogu, South Korea, 49267

Active, Not Recruiting

60

Severance Hospital, Yonsei University Health System,Substudy-03

Seoul, South Korea, 03722

Actively Recruiting

61

Asan Medical Center,Substudy-02

Seoul, South Korea, 05505

Active, Not Recruiting

62

Asan Medical Center,Substudy-03

Seoul, South Korea, 05505

Actively Recruiting

63

Asan Medical Centre,Substudy-01

Seoul, South Korea, 05505

Active, Not Recruiting

64

Samsung Medical Center,Substudy-01

Seoul, South Korea, 06351

Active, Not Recruiting

65

Samsung Medical Center,Substudy-02

Seoul, South Korea, 06351

Active, Not Recruiting

66

Samsung Medical Center,Substudy-03

Seoul, South Korea, 06351

Actively Recruiting

67

Severance Hospital, Yonsei University Health System,Substudy-01

Seoul, South Korea, 120-752

Actively Recruiting

68

Severance Hospital, Yonsei University Health System,Substudy-02

Seoul, South Korea, 120-752

Active, Not Recruiting

69

Seoul National University,Substudy-01

Seoul, South Korea, 463-707

Withdrawn

70

Seoul National University,Substudy-02

Seoul, South Korea, 463-707

Active, Not Recruiting

71

Korea University Guro Hospital,Substudy-01

Seoul, South Korea, 8308

Active, Not Recruiting

72

Korea University Guro Hospital,Substudy-03

Seoul, South Korea, 8308

Actively Recruiting

73

Changhua Christian Hospital,Substudy-01

Changhua, Taiwan, 500-06

Actively Recruiting

74

Changhua Christian Hospital,Substudy-02

Changhua, Taiwan, 500-06

Active, Not Recruiting

75

Changhua Christian Hospital,Substudy-03

Changhua, Taiwan, 500-06

Actively Recruiting

76

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01

Kaohsiung City, Taiwan, 80756

Active, Not Recruiting

77

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02

Kaohsiung City, Taiwan, 80756

Active, Not Recruiting

78

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03

Kaohsiung City, Taiwan, 80756

Actively Recruiting

79

Kaohsiung Chang Gung Memorial Hospital,Substudy-01

Kaohsiung City, Taiwan, 83301

Actively Recruiting

80

Kaohsiung Chang Gung Memorial Hospital,Substudy-02

Kaohsiung City, Taiwan, 83301

Active, Not Recruiting

81

Kaohsiung Chang Gung Memorial Hospital,Substudy-03

Kaohsiung City, Taiwan, 83301

Actively Recruiting

82

National Taiwan University Hospital,Substudy-01

Taipei, Taiwan, 100

Actively Recruiting

83

National Taiwan University Hospital,Substudy-02

Taipei, Taiwan, 100

Active, Not Recruiting

84

Adana City Training and Research Hospital,Substudy-01

Adana, Turkey (Türkiye), 01120

Actively Recruiting

85

Memorial Ankara Hastanesi,Substudy-01

Ankara, Turkey (Türkiye), 06520

Actively Recruiting

86

Memorial Ankara Hospital,Substudy-03

Ankara, Turkey (Türkiye), 06520

Actively Recruiting

87

Medical Park Samsun,Substudy-01

Atakum, Turkey (Türkiye), 55200

Actively Recruiting

88

Dicle University,Substudy-01

Diyarbakır, Turkey (Türkiye), 21100

Actively Recruiting

89

Dicle University Medical Faculty,Substudy-03

Diyarbakır, Turkey (Türkiye), 21280

Actively Recruiting

90

Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01

Konya, Turkey (Türkiye), 42080

Actively Recruiting

91

Necmettin Erbakan Universitesi,Substudy-03

Meram Konya, Turkey (Türkiye), 42080

Actively Recruiting

92

Gazi University Medical Faculty,Substudy-01

Yenimahalle, Turkey (Türkiye)

Actively Recruiting

93

Gazi University Medical Faculty,Substudy-03

Yenimahalle, Turkey (Türkiye)

Actively Recruiting

94

Birmingham Heartlands Hospital,Substudy-03

Birmingham, United Kingdom, B9 5SS

Active, Not Recruiting

95

University Hospitals Birmingham NHS Trust,Substudy-01

Birmingham, United Kingdom, B9 5SS

Active, Not Recruiting

96

University Hospitals Birmingham NHS Trust,Substudy-02

Birmingham, United Kingdom, B9 5SS

Active, Not Recruiting

97

St James University Hospital,,Substudy-01

Leeds, United Kingdom, LS9 7TF

Actively Recruiting

98

St. Bartholomew's Hospital,Substudy-01

London, United Kingdom, E1 1BB

Actively Recruiting

99

St. Bartholomew's Hospital,Substudy-02

London, United Kingdom, E1 1BB

Active, Not Recruiting

100

St. Bartholomew's Hospital,Substudy-03

London, United Kingdom, E1 1BB

Actively Recruiting

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Research Team

G

Gilead Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

10

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Study of Novel Treatment Combinations in Patients With Lung Cancer | DecenTrialz