A trial to learn how safe newer immunotherapy drugs are and how well they work with or without other anti-cancer drugs in adults with advanced, unresectable non-small cell lung cancer

Trial details

Who runs it

AstraZeneca AB

Trial code

EU 2025-523599-21-00

Record updated

2026. augusztus 13.

Original description

To assess the safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLCRead full original descriptionShow less

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)

To assess the safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC

Inclusion: Histologically or cytologically documented squamous or non-squamous NSCLC; Unresectable stage III NSCLC eligible for concurrent chemoradiation. (Stage should be determined based on IASLC v9.0 Staging Guidelines; resectability should be determined by a multidisciplinary evaluation.); Documented absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) rearrangements; No known ROS1 or RET rearrangements detected as per local standard practice; Eligible for definitive, platinum-based cCRT to a total radiation dose of 60 Gy in 30 fractions using photons; ECOG performance status of 0 or 1; and 10. Known tumor PD-L1 "XXX" expression using documented local results with confirmed availablity of tumor tissue sample to confirm PD-L1 expression results; At least one lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (preferred) or MRI, and is suitable for accurate repeated measurements; Adequate organ and bone marrow function.

Exclusion: History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years prior to treatment assigment and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease; Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment; Any prior or current systemic or radiation therapy received for NSCLC, or prior radiation therapy for any malignancy that included any lung tissue in the prior radiation fields; Prior exposure to an anti-PD-1, anti-PD-L1, or anti-TIGIT therapy, or any other anticancer therapy targeting immune regulatory receptors or mechanisms; Malignant pleural or pericardial effusion. Effusions must be assessed via thoracentesis or pericardiocentesis; History of idiopathic pulmonary fibrosis, ILD, non-infectious/radiation ILD/pneumonitis that required steroids or any active signs of these conditions that cannot be ruled out by imaging at screening. Additional exclusions include organizing pneumonia or drug-induced pneumonitis/ILD; History of organ transplant or allogeneic stem cell transplant; Presence of small cell and/or neuroendocrine histology components; sarcomatoid variant; and/or other rare subtypes; Tumor invasion of the great vessels (aorta, superior/inferior vena cava, and/or intrapericardial vessels).

EU CTIS 2025-523599-21-00