A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
Part of paid clinical trials in Santa Monica, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT07098338
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rilvegostomig — DRUGRilvegostomig will be administered as IV infusion.
- Ramucirumab — DRUGRamucirumab will be administered as IV infusion.
- Dato-DXd — DRUGDato-DXd will be administered as IV infusion.
Study Details
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.
Key Dates
- Start date
- Aug 7, 2025
- Status verified
- May 2026
- Primary completion
- Apr 6, 2029
- Completion
- Apr 6, 2029
Study Design
- Enrollment
- 278 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: 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, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
- Experimental: 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, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
- Experimental: Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLCParticipants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Primary Outcome Measure
Number of participants with adverse events (AE) and serious adverse events (SAE) [ Time Frame: Through study completion, an average of 3 years ]
Central Contacts
- AstraZeneca Clinical Study Information Center1-877-240-9479
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Santa Monica | California | 90404 | - |
| Research Site | Santa Rosa | California | 95403 | - |
| Research Site | Atlanta | Georgia | 30318 | - |
| Research Site | Baltimore | Maryland | 21231 | - |
| Research Site | Houston | Texas | 77090 | - |
| Research Site | Fairfax | Virginia | 22031 | - |
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