Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

527

Participants

Timeline

Start Date

December 18, 2017

Primary Completion Date

September 13, 2024

Study Completion Date

September 11, 2026

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Durvalumab

Durvalumab given IV at 1500 mg Q4W ±2 days

DRUG

AZD9150

AZD9150 given IV at 200mg every other day of a 1-week lead-in period followed by QW

DRUG

AZD6738

AZD6738 given orally at 240mg twice daily in Cycle 0 Days 1-7, followed by 7 days on treatment in each cycle between Days 22-28

DRUG

Vistusertib

Vistusertib (AZD2014) given orally at a dose of 125 mg BD on an intermittent dosing schedule of 2 days on, 5 days off

DRUG

Olaparib

Olaparib (AZD2281) given orally at 300 mg BD

DRUG

Oleclumab

Oleclumab given at dose level 1 for 2 cycles and then dose level 2 thereafter

DRUG

trastuzumab deruxtecan

Durvalumab given IV at 1120mg Q3W ±2 days for Module 6 only \& trastuzumab deruxtecan given at 5.4 mg/kg via IV infusion Q3W ±2 days

DRUG

cediranib

cediranib given orally at 20 mg tablets on an intermittent schedule (5 days on, 2 days off), starting on C1D1

DRUG

AZD6738 (ceralasertib)

AZD6738 given at 240 mg twice daily for 14 days on treatment in each 28-day cycle, between Days 1 and 14.

DRUG

AZD6738 (ceralasertib)

AZD6738 given orally at 240mg twice daily for 14 days in each 28 day cycle (starting from Cycle 1) between Days 15-28

DRUG

AZD6738 (ceralasertib) (240 mg or 160 mg)

AZD6738 given orally at 240mg or 160mg twice daily in Cycle 0 Days 1-7, followed by 7 days on treatment in each cycle between Days 22-28

DRUG

AZD6738 (ceralasertib) 7 days monotherapy

AZD6738 given orally at 240 mg twice daily for 7 days on Day 1-7 in each 28 day cycle

Trial Locations (45)

1140

Research Site, Vienna

1210

Research Site, Vienna

5020

Research Site, Salzburg

6020

Research Site, Innsbruck

6351

Research Site, Seoul

10032

Research Site, New York

12203

Research Site, Berlin

15232

Research Site, Pittsburgh

19111

Research Site, Philadelphia

20016

Research Site, Washington D.C.

21224

Research Site, Baltimore

21287

Research Site, Baltimore

22031

Research Site, Fairfax

22927

Research Site, Großhansdorf

28007

Research Site, Madrid

28034

Research Site, Madrid

31096

Research Site, Haifa

33076

Research Site, Bordeaux

37203

Research Site, Nashville

37212

Research Site, Nashville

41009

Research Site, Seville

44093

Research Site, Nantes

49100

Research Site, Petah Tikva

60637

Research Site, Chicago

63110

Research Site, St Louis

69126

Research Site, Heidelberg

73730

Research Site, Esslingen a.N.

75877

Research Site, Paris

77030

Research Site, Houston

90095

Research Site, Los Angeles

91010

Research Site, Duarte

92093

Research Site, La Jolla

92835

Research Site, Fullerton

94800

Research Site, Villejuif

95847

Research Site, Kfar Saba

5265601

Research Site, Ramat Gan

02215

Research Site, Boston

T6G 1Z2

Research Site, Edmonton

L6R 3J7

Research Site, Brampton

K1H 8L6

Research Site, Ottawa

M5G 2M9

Research Site, Toronto

H2X 3E4

Research Site, Montreal

03080

Research Site, Seoul

05505

Research Site, Seoul

08036

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY