A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
Start Date
8/7/2025
Completion Date
4/6/2029
Summary
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.
Detailed Description
The master protocol will include 3 sub-studies, each focused on a specific disease population. * Sub-study 1 will investigate rilvegostomig± ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 ≥50%. * Sub-study 2 will investigate rilvegostomig + ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 1-49%. * Sub-study 3 will investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ Each sub-study may include 2 parts (unless stated in the individual sub study protocols): Part A: one or more Safety Run-in cohort(s), and Part B: one or more Dose Expansion cohort(s).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Rilvegostomig
Ramucirumab
Dato-DXd
Conditions
Locations
Research Site
Santa Monica, California 90404
United States
Research Site
Santa Rosa, California 95403
United States
Research Site
Atlanta, Georgia 30318
United States
Research Site
Baltimore, Maryland 21231
United States
Research Site
Houston, Texas 77090
United States
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Fairfax, Virginia 22031
United States
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Heidelberg, 3084
Australia
Research Site
Nedlands, 6009
Australia
Research Site
Woodville, 5011
Australia
Research Site
Toronto, Ontario M5G 2M9
Canada
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Changsha, 410013
China
Research Site
Chengdu, 610041
China
Research Site
Deyang, 618000
China
Research Site
Dongguan, 523059
China
Research Site
Fuzhou, 350014
China
Research Site
Guangzhou, 510080
China
Research Site
Guangzhou, 510100
China
Research Site
Hangzhou, 310014
China
Research Site
Hefei, 230022
China
Research Site
Linyi, 276001
China
Research Site
Mianyang, 621000
China
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Nanchang, 330000
China
Research Site
Nanchang, 330006
China
Research Site
Shantou,
China
Research Site
Shenyang, 110042
China
Research Site
Wuhan, 430022
China
Research Site
Zhengzhou, 450000
China
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Zhengzhou, 450008
China
Research Site
Zhuhai, 519000
China
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Avignon, 84902
France
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Paris, 75005
France
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Rennes, 35000
France
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Saint-Herblain, 44805
France
Research Site
Suresnes, 92150
France
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Aviano, 33081
Italy
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Catania, 95123
Italy
Research Site
Meldola, 47014
Italy
Research Site
Milan, 20141
Italy
Research Site
Milan, 35128
Italy
Research Site
Orbassano, 10043
Italy
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Roma, 00144
Italy
Research Site
Rozzano, 20089
Italy
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Bunkyō City, 113-8677
Japan
Research Site
Fukuyama-shi, 722-0001
Japan
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Kobe, 650-0047
Japan
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Kurume-shi, 830-0011
Japan
Research Site
Kyoto, 602-8566
Japan
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Kyoto, 606-8507
Japan
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Osaka, 541-8567
Japan
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Sakaishi, 591-8555
Japan
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Shinjuku-ku, 162-8655
Japan
Research Site
Wakayama, 641-8510
Japan
Research Site
Yokohama, 236-0051
Japan
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Singapore, 119082
Singapore
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Singapore, 168583
Singapore
Research Site
Cheongju-si, 28644
South Korea
Research Site
Namdong-gu, 21565
South Korea
Research Site
Seongnam-si, 13496
South Korea
Research Site
Seoul, 03080
South Korea
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Seoul, 06351
South Korea
Research Site
Seoul, 3722
South Korea
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Seoul, 5505
South Korea
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Suwon, 16247
South Korea
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Suwon, 16499
South Korea
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A Coruña, 15006
Spain
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Madrid, 28041
Spain
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Manresa, 08243
Spain
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Málaga, 29009
Spain
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Santander, 39008
Spain
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Valencia, 46010
Spain
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Liuying, 736
Taiwan
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Taichung, 402
Taiwan
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Taichung, 40447
Taiwan
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Tainan, 70403
Taiwan
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Tainan, 710
Taiwan
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Taipei, 100
Taiwan
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Taipei, 110
Taiwan
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Taipei, 11217
Taiwan
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Taoyuan, 00333
Taiwan
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Bangkok, 10330
Thailand
Research Site
Bangkok, 10400
Thailand
Research Site
Bangkok, 10700
Thailand
Research Site
Banphaeo, 74120
Thailand