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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria for All Sub-studies:
* Participant must be ≥ 18 years of age at the time of signing the ICF
* 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
Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
* 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)
Specific Inclusion Criteria for Sub-Study 3:
* Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
* Documented positive AGA and had progressed on prior targeted therapy
Exclusion Criteria for All Sub-studies:
* As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
* 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.
Primary outcome measure(s)
Number of participants with adverse events (AE) and serious adverse events (SAE) — Through study completion, an average of 3 years To assess the safety and tolerability
Objective response rate (ORR) — Through study completion, an average of 3 years ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1
Trial sites (83)
Facility
City
Region
Status
Research Site
Santa Monica
California
Recruiting
Research Site
Santa Rosa
California
Not Yet Recruiting
Research Site
Atlanta
Georgia
Recruiting
Research Site
Baltimore
Maryland
Not Yet Recruiting
Research Site
Houston
Texas
Not Yet Recruiting
Research Site
Fairfax
Virginia
Recruiting
Research Site
Heidelberg
Australia
Not Yet Recruiting
Research Site
Nedlands
Australia
Not Yet Recruiting
Research Site
Woodville
Australia
Not Yet Recruiting
Research Site
Toronto
Ontario
Not Yet Recruiting
Research Site
Changsha
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Deyang
China
Recruiting
Research Site
Dongguan
China
Recruiting
Research Site
Fuzhou
China
Withdrawn
Research Site
Guangzhou
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Hangzhou
China
Recruiting
Research Site
Hefei
China
Recruiting
Research Site
Linyi
China
Recruiting
Research Site
Mianyang
China
Recruiting
Research Site
Nanchang
China
Recruiting
Research Site
Nanchang
China
Recruiting
Research Site
Shantou
China
Recruiting
Research Site
Shenyang
China
Recruiting
Research Site
Wuhan
China
Recruiting
Research Site
Zhengzhou
China
Recruiting
Research Site
Zhengzhou
China
Recruiting
Research Site
Zhuhai
China
Recruiting
Research Site
Avignon
France
Not Yet Recruiting
Research Site
Paris
France
Not Yet Recruiting
Research Site
Rennes
France
Not Yet Recruiting
Research Site
Saint-Herblain
France
Not Yet Recruiting
Research Site
Suresnes
France
Recruiting
Research Site
Aviano
Italy
Not Yet Recruiting
Research Site
Catania
Italy
Not Yet Recruiting
Research Site
Meldola
Italy
Not Yet Recruiting
Research Site
Milan
Italy
Not Yet Recruiting
Research Site
Milan
Italy
Not Yet Recruiting
Research Site
Orbassano
Italy
Not Yet Recruiting
+ 43 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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