Study of New Combinations for Non-Small Cell Lung Cancer

This study is testing new combinations of treatments for people with locally advanced or metastatic non-small cell lung cancer (NSCLC). Researchers want to see how safe these combinations are and if they help shrink tumors. The treatments being studied include Rilvegostomig, Ramucirumab, and Dato-DXd, given as IV infusions (into a vein). You might be able to join if you are at least 18 years old, have a good general health status (WHO/ECOG performance status of 0 or 1), and have at least one measurable tumor. The study will look at how many people experience side effects and how many see their tumors shrink. Your tumor tissue will also be analyzed for specific biomarkers like ALK, EGFR, and PD-L1.

Study design
This is a Phase II, multi-center, open-label study with 278 planned participants. It has several sub-studies, each testing different treatment combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and tumor response through study completion, which is an average of 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07098338

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~278 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:RilvegostomigRamucirumabDato-DXd

At a glance

Recruiting sites
58 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AE) and serious adverse events (SAE)
Measured over Through study completion, an average of 3 years
+1 more outcome measured
Non-Small Cell Lung Cancer
83 sites across 16 states
China19
Japan11
South Korea9
Taiwan9
Italy8
Spain6
France5
Thailand4
AstraZeneca Clinical Study Information Center
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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.
  • 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