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 — DRUG
    Rilvegostomig will be administered as IV infusion.
  • Ramucirumab — DRUG
    Ramucirumab will be administered as IV infusion.
  • Dato-DXd — DRUG
    Dato-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+ NSCLC
    Participants 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

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteSanta MonicaCalifornia90404-
Research SiteSanta RosaCalifornia95403-
Research SiteAtlantaGeorgia30318-
Research SiteBaltimoreMaryland21231-
Research SiteHoustonTexas77090-
Research SiteFairfaxVirginia22031-

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