A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT07098338
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
278 participants
INTERVENTIONAL
2025-08-07
2029-04-06
Brief Summary
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Detailed Description
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* 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 2L 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).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%
Participants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Rilvegostomig
Rilvegostomig will be administered as IV infusion.
Ramucirumab
Ramucirumab will be administered as IV infusion.
Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%
Participants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Rilvegostomig
Rilvegostomig will be administered as IV infusion.
Ramucirumab
Ramucirumab will be administered as IV infusion.
Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2L AGA+ NSCLC
Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Rilvegostomig
Rilvegostomig will be administered as IV infusion.
Ramucirumab
Ramucirumab will be administered as IV infusion.
Dato-DXd
Dato-DXd will be administered as IV infusion.
Interventions
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Rilvegostomig
Rilvegostomig will be administered as IV infusion.
Ramucirumab
Ramucirumab will be administered as IV infusion.
Dato-DXd
Dato-DXd will be administered as IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* WHO/ECOG performance status of 0 or 1
* At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
* Adequate bone marrow and organ function
* Life expectancy ≥ 12 weeks
* Provision of acceptable tumour tissue
* Histologically or cytologically documented advanced or metastatic NSCLC
* PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
* Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
* Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
* Documented positive AGA and had progressed on prior targeted therapy
Exclusion Criteria
* Active or prior documented autoimmune or inflammatory disorders
* Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
* Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
* Unstable brain metastases
* History of another primary malignancy.
* Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
* Uncontrolled or significant cardiac disease
* Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
* Prior exposure to immune-mediated therapy
* History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
* Any concurrent anti-cancer treatment.
* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Santa Monica, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Baltimore, Maryland, United States
Research Site
Houston, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Nedlands, , Australia
Research Site
Woodville, , Australia
Research Site
Toronto, Ontario, Canada
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Deyang, , China
Research Site
Dongguan, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Linyi, , China
Research Site
Mianyang, , China
Research Site
Nanchang, , China
Research Site
Nanchang, , China
Research Site
Shantou, , China
Research Site
Shenyang, , China
Research Site
Wuhan, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Research Site
Zhuhai, , China
Research Site
Bunkyō City, , Japan
Research Site
Kobe, , Japan
Research Site
Kurume-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Osaka, , Japan
Research Site
Sakaishi, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Wakayama, , Japan
Research Site
Yokohama, , Japan
Research Site
Singapore, , Singapore
Research Site
Cheongju-si, , South Korea
Research Site
Namdong-gu, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Suwon, , South Korea
Research Site
Liuying, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Banphaeo, , Thailand
Countries
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Central Contacts
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Other Identifiers
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D6187C00001
Identifier Type: -
Identifier Source: org_study_id
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