A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

PHASE3RecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

April 4, 2024

Primary Completion Date

August 17, 2027

Study Completion Date

March 20, 2031

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Durvalumab

Participants will receive intravenous (IV) Durvalumab q3w for four 21-day cycles as induction treatment. Durvalumab will also be given during the maintenance treatment period q4w until disease progression or unacceptable toxicity.

DRUG

Tremelimumab

Participants will receive IV Tremelimumab q3w for four 21-days cycles as induction treatment. Tremelimumab will also be given during the maintenance therapy phase at week 16 and week 104 (at the investigators discretion).

DRUG

Pemetrexed

Participants in Arm A and Arm B will receive IV pemetrexed q3w for four 21-day cycles as induction treatment. In the maintenance therapy phase, Treatment Arm A will receive Pemetrexed q4w, Treatment Arm B will receive Pemetrexed q3w until disease progression or unacceptable toxicity.

DRUG

Pembrolizumab

Participants will receive IV pembrolizumab q3w for four 21-days cycles as induction treatment. Pembrolizumab will also be given in the maintenance treatment phase q3w until disease progression or unacceptable toxicity or up to 24 months.

DRUG

Carboplatin

Participants will receive IV Carboplatin or IV Cisplatin on Day 1 of each 21-day cycle for 4 cycles as induction treatment.

DRUG

Cisplatin

Participants will receive IV Carboplatin or IV Cisplatin on Day 1 of each 21-day cycle for 4 cycles as induction treatment.

Trial Locations (105)

10016

WITHDRAWN

Research Site, New York

10028

RECRUITING

Research Site, New York

10032

RECRUITING

Research Site, New York

10065

RECRUITING

Research Site, New York

10461

RECRUITING

Research Site, The Bronx

10469

RECRUITING

Research Site, The Bronx

11042

RECRUITING

Research Site, New Hyde Park

11501

WITHDRAWN

Research Site, Mineola

11590

RECRUITING

Research Site, Westbury

11768

RECRUITING

Research Site, Northport

11790

RECRUITING

Research Site, Stony Brook

11967

RECRUITING

Research Site, Shirley

12065

RECRUITING

Research Site, Clifton Park

12206

RECRUITING

Research Site, Albany

13057

RECRUITING

Research Site, East Syracuse

13210

RECRUITING

Research Site, Syracuse

15212

RECRUITING

Research Site, Pittsburgh

17033

RECRUITING

Research Site, Hershey

19111

WITHDRAWN

Research Site, Philadelphia

19131

WITHDRAWN

Research Site, Philadelphia

20007

RECRUITING

Research Site, Washington D.C.

20010

RECRUITING

Research Site, Washington D.C.

20817

RECRUITING

Research Site, Bethesda

22031

RECRUITING

Research Site, Fairfax

22908

WITHDRAWN

Research Site, Charlottesville

23298

RECRUITING

Research Site, Richmond

30303

WITHDRAWN

Research Site, Atlanta

30318

RECRUITING

Research Site, Atlanta

30322

RECRUITING

Research Site, Atlanta

31701

RECRUITING

Research Site, Albany

31904

RECRUITING

Research Site, Columbus

32804

RECRUITING

Research Site, Orlando

33308

RECRUITING

Research Site, Fort Lauderdale

33458

RECRUITING

Research Site, Jupiter

33607

RECRUITING

Research Site, Tampa

33612

WITHDRAWN

Research Site, Tampa

33705

RECRUITING

Research Site, St. Petersburg

34474

RECRUITING

Research Site, Ocala

35233

WITHDRAWN

Research Site, Birmingham

37212

RECRUITING

Research Site, Nashville

38104

WITHDRAWN

Research Site, Memphis

RECRUITING

Research Site, Memphis

38120

RECRUITING

Research Site, Memphis

40206

RECRUITING

Research Site, Louisville

40502

RECRUITING

Research Site, Lexington

43210

RECRUITING

Research Site, Columbus

43537

RECRUITING

Research Site, Maumee

43551

RECRUITING

Research Site, Perrysburg

43623

WITHDRAWN

Research Site, Toledo

44111

RECRUITING

Research Site, Cleveland

44124

RECRUITING

Research Site, Cleveland

44195

RECRUITING

Research Site, Cleveland

45459

RECRUITING

Research Site, Dayton

46311

RECRUITING

Research Site, Dyer

47713

RECRUITING

Research Site, Evansville

48201

RECRUITING

Research Site, Detroit

48334

WITHDRAWN

Research Site, Farmington Hills

48912

WITHDRAWN

Research Site, Lansing

49684

WITHDRAWN

Research Site, Traverse City

53215

RECRUITING

Research Site, Milwaukee

55101

RECRUITING

Research Site, Saint Paul

57105

RECRUITING

Research Site, Sioux Falls

58501

RECRUITING

Research Site, Bismarck

59102

RECRUITING

Research Site, Billings

60153

NOT_YET_RECRUITING

Research Site, Maywood

60607

RECRUITING

Research Site, Chicago

60612

WITHDRAWN

Research Site, Chicago

61801

RECRUITING

Research Site, Urbana

62918

RECRUITING

Research Site, Carterville

63110

RECRUITING

Research Site, St Louis

63128

RECRUITING

Research Site, St Louis

64111

RECRUITING

Research Site, Kansas City

64132

RECRUITING

Research Site, Kansas City

66205

RECRUITING

Research Site, Westwood

68506

RECRUITING

Research Site, Lincoln

68803

RECRUITING

Research Site, Grand Island

73072

RECRUITING

Research Site, Norman

75246

RECRUITING

Research Site, Dallas

WITHDRAWN

Research Site, Dallas

76104

RECRUITING

Research Site, Fort Worth

76210

RECRUITING

Research Site, Denton

77030

RECRUITING

Research Site, Houston

77090

RECRUITING

Research Site, Houston

77339

RECRUITING

Research Site, Kingwood

78212

WITHDRAWN

Research Site, San Antonio

78229

RECRUITING

Research Site, San Antonio

78745

RECRUITING

Research Site, Austin

80033

RECRUITING

Research Site, Wheat Ridge

80218

RECRUITING

Research Site, Denver

85224

WITHDRAWN

Research Site, Chandler

85724

RECRUITING

Research Site, Tucson

90034

RECRUITING

Research Site, Los Angeles

90095

WITHDRAWN

Research Site, Los Angeles

90211

RECRUITING

Research Site, Beverly Hills

90404

RECRUITING

Research Site, Santa Monica

90720

RECRUITING

Research Site, Los Alamitos

92093

RECRUITING

Research Site, La Jolla

92357

RECRUITING

Research Site, Loma Linda

92618

RECRUITING

Research Site, Irvine

96001

RECRUITING

Research Site, Redding

96813

RECRUITING

Research Site, Honolulu

99508

RECRUITING

Research Site, Anchorage

02130

RECRUITING

Research Site, Jamaica Plain

01655

RECRUITING

Research Site, Worcester

02906

WITHDRAWN

Research Site, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY