Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07098338

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

Led by AstraZeneca · Updated on 2026-04-29

278

Participants Needed

64

Research Sites

191 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

D

Daiichi Sankyo

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.

CONDITIONS

Official Title

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be 18 years of age or older at the time of consent
  • WHO/ECOG performance status of 0 or 1
  • At least one measurable lesion according to RECIST 1.1 at baseline
  • Adequate bone marrow and organ function
  • Life expectancy of at least 12 weeks
  • Provision of acceptable tumor tissue sample
  • For Sub-Studies 1 and 2: Histologically or cytologically confirmed advanced or metastatic NSCLC
  • PD-L1 tumor cell expression of at least 1% (50% or more for Sub-Study 1; 1-49% for Sub-Study 2)
  • No sensitizing EGFR mutations or ALK rearrangements; no other known actionable genomic alterations
  • For Sub-Study 3: Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC
  • Documented positive actionable genomic alteration and progression on prior targeted therapy
Not Eligible

You will not qualify if you...

  • Any severe or uncontrolled systemic disease making participation undesirable or jeopardizing protocol compliance
  • Active or prior documented autoimmune or inflammatory disorders
  • Persistent toxicities Grade 2 or higher caused by prior anticancer therapy, excluding hair loss
  • Spinal cord compression or leptomeningeal carcinomatosis (for Sub-Studies 1 and 2); unstable spinal cord compression (for Sub-Study 3)
  • Unstable brain metastases
  • History of another primary malignancy
  • Active infection including tuberculosis, HIV, hepatitis B, or hepatitis C
  • Uncontrolled or significant cardiac disease
  • Prior systemic chemotherapy, chemoradiation, or immunotherapy for advanced NSCLC (for Sub-Studies 1 and 2)
  • Prior exposure to immune-mediated therapy
  • History of uncontrolled hypertension, active bleeding, or bleeding disorders
  • Any concurrent anti-cancer treatment
  • Receipt of live, attenuated vaccine within 30 days prior to first study drug dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 64 locations

1

Research Site

Santa Monica, California, United States, 90404

Not Yet Recruiting

2

Research Site

Santa Rosa, California, United States, 95403

Not Yet Recruiting

3

Research Site

Atlanta, Georgia, United States, 30318

Actively Recruiting

4

Research Site

Baltimore, Maryland, United States, 21231

Not Yet Recruiting

5

Research Site

Houston, Texas, United States, 77090

Not Yet Recruiting

6

Research Site

Fairfax, Virginia, United States, 22031

Actively Recruiting

7

Research Site

Heidelberg, Australia, 3084

Not Yet Recruiting

8

Research Site

Nedlands, Australia, 6009

Not Yet Recruiting

9

Research Site

Woodville, Australia, 5011

Not Yet Recruiting

10

Research Site

Toronto, Ontario, Canada, M5G 2M9

Not Yet Recruiting

11

Research Site

Changsha, China, 410013

Actively Recruiting

12

Research Site

Chengdu, China, 610041

Actively Recruiting

13

Research Site

Deyang, China, 618000

Actively Recruiting

14

Research Site

Dongguan, China, 523059

Actively Recruiting

15

Research Site

Fuzhou, China, 350014

Not Yet Recruiting

16

Research Site

Guangzhou, China, 510080

Actively Recruiting

17

Research Site

Guangzhou, China, 510100

Actively Recruiting

18

Research Site

Hangzhou, China, 310014

Actively Recruiting

19

Research Site

Hefei, China, 230022

Actively Recruiting

20

Research Site

Linyi, China, 276001

Actively Recruiting

21

Research Site

Mianyang, China, 621000

Actively Recruiting

22

Research Site

Nanchang, China, 330000

Actively Recruiting

23

Research Site

Nanchang, China, 330006

Actively Recruiting

24

Research Site

Shantou, China

Actively Recruiting

25

Research Site

Shenyang, China, 110042

Actively Recruiting

26

Research Site

Wuhan, China, 430022

Actively Recruiting

27

Research Site

Zhengzhou, China, 450000

Actively Recruiting

28

Research Site

Zhengzhou, China, 450008

Actively Recruiting

29

Research Site

Zhuhai, China, 519000

Actively Recruiting

30

Research Site

Bunkyō City, Japan, 113-8677

Actively Recruiting

31

Research Site

Fukuyama-shi, Japan, 722-0001

Actively Recruiting

32

Research Site

Kobe, Japan, 650-0047

Actively Recruiting

33

Research Site

Kurume-shi, Japan, 830-0011

Actively Recruiting

34

Research Site

Kyoto, Japan, 602-8566

Actively Recruiting

35

Research Site

Kyoto, Japan, 606-8507

Actively Recruiting

36

Research Site

Osaka, Japan, 541-8567

Actively Recruiting

37

Research Site

Sakaishi, Japan, 591-8555

Actively Recruiting

38

Research Site

Shinjuku-ku, Japan, 162-8655

Actively Recruiting

39

Research Site

Wakayama, Japan, 641-8510

Actively Recruiting

40

Research Site

Yokohama, Japan, 236-0051

Actively Recruiting

41

Research Site

Singapore, Singapore, 119082

Actively Recruiting

42

Research Site

Singapore, Singapore, 168583

Actively Recruiting

43

Research Site

Cheongju-si, South Korea, 28644

Actively Recruiting

44

Research Site

Namdong-gu, South Korea, 21565

Actively Recruiting

45

Research Site

Seongnam-si, South Korea, 13496

Actively Recruiting

46

Research Site

Seoul, South Korea, 03080

Actively Recruiting

47

Research Site

Seoul, South Korea, 06351

Actively Recruiting

48

Research Site

Seoul, South Korea, 3722

Actively Recruiting

49

Research Site

Seoul, South Korea, 5505

Actively Recruiting

50

Research Site

Suwon, South Korea, 16247

Actively Recruiting

51

Research Site

Suwon, South Korea, 16499

Actively Recruiting

52

Research Site

Liuying, Taiwan, 736

Actively Recruiting

53

Research Site

Taichung, Taiwan, 402

Actively Recruiting

54

Research Site

Taichung, Taiwan, 40447

Actively Recruiting

55

Research Site

Tainan, Taiwan, 70403

Actively Recruiting

56

Research Site

Tainan, Taiwan, 710

Actively Recruiting

57

Research Site

Taipei, Taiwan, 100

Actively Recruiting

58

Research Site

Taipei, Taiwan, 110

Actively Recruiting

59

Research Site

Taipei, Taiwan, 11217

Actively Recruiting

60

Research Site

Taoyuan, Taiwan, 00333

Actively Recruiting

61

Research Site

Bangkok, Thailand, 10330

Not Yet Recruiting

62

Research Site

Bangkok, Thailand, 10400

Not Yet Recruiting

63

Research Site

Bangkok, Thailand, 10700

Not Yet Recruiting

64

Research Site

Banphaeo, Thailand, 74120

Not Yet Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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