A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523599-21-00

Enrollment

Registered

2026-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

The safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC will be assessed.

Detailed description

PFS is defined as time from the date of treatment assignment/randomization or Cycle 1 Day 1 (as applicable, depending on the design of the relevant substudy) until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression)., ORR is defined as the proportion of participants who have a CR or PR, "XXX" per RECIST 1.1 for induction therapy or overall., Concentration of immunotherapy in serum., Presence of anti-drug antibodies (ADAs), positive or negative and titers

Interventions

DRUGPEMETREXED

DRUGCARBOPLATIN

DRUGRilvegostomig

DRUGPACLITAXEL

DRUGMYCOPHENOLATE MOFETIL

DRUGCISPLATIN

DRUGINFLIXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC will be assessed.	—

Secondary

Measure	Time frame
PFS is defined as time from the date of treatment assignment/randomization or Cycle 1 Day 1 (as applicable, depending on the design of the relevant substudy) until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression)., ORR is defined as the proportion of participants who have a CR or PR, "XXX" per RECIST 1.1 for induction therapy or overall., Concentration of immunotherapy in serum., Presence of anti-drug antibodies (ADAs), positive or negative and titers	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 1, 2026