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Clinical Trials in the USA / NCT07098338
Recruiting Phase 2

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

NCT07098338 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2025-08-07
Last updated
2026-07-01

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

RilvegostomigRamucirumabDato-DXd

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)

Trial sites (83)

FacilityCityRegionStatus
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.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT07098338 on ClinicalTrials.gov ↗ ← All trials in the USA