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Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen

AUSTRAL Trial: An Open-Label, Multicenter, Phase II Study Of Radiotherapy Followed By Durvalumab (MEDI4736) And Ceralasertib (AZD6738) In Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen

NCT06680050•Mario Negri Institute for Pharmacological Research

View on ClinicalTrials.gov

Summary

Aim of this phase 2 study is to explore the safety and efficacy of thoracic re-irradiation +/- SBRT to oligometastases (\<3) followed after an interval of 2 weeks by durvalumab and ceralasertib for patients with thoracic relapses +/- oligometastases after PACIFIC or PACIFIC-like (concurrent or sequential chemo-radiotherapy followed by maintenance durvalumab) regimens.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed, written and dated informed consent and any locally required authorization
•2. Male or female aged 18 years or older
•3. ECOG Performance Status of 0-2
•4. Life expectancy ≥ 6 months at the start of treatment
•5. Body weight \>30kg
•6. Maintenance treatment with durvalumab for a minimum of 3 months
•7. Histologically or cytologically documented locally advanced NSCLC at relapse
•8. Measurable disease as defined by RECIST v1.1
•9. Documented tumor cell PD-L1 status at first diagnosis and/or at relapse
•10. Thoracic progression as defined by PACIFIC protocol, with or without a maximum of 3 metastatic lesions amenable to local radiotherapy (at discretion of treating center)
+6 more criteria

Exclusion Criteria

•1. Patients who discontinued durvalumab due to local or systemic progression during the maintenance phase \< 12 months after the end of CRT
•2. Patients who experienced, during the maintenance phase with durvalumab after CRT, grade 3 or more documented immune-related toxicity (with the exception of fully recovered endocrine toxicities) or grade 3 or more radiation-induced pneumonitis.
•3. Any unresolved toxicity NCI CTCAE from previous anticancer therapy not completely resolved or not resolved to baseline prior to screening for this study with the exception of alopecia, vitiligo, and the laboratory values defined below
•1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
•2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
•3. Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
•4. Any toxicity that led to permanent discontinuation of prior immunotherapy
•5. Patients with more than 3 distant metastases (non-oligometastatic disease)
•6. Patients with metastatic disease progression not amenable for radical radiotherapy such as malignant ascites, pleural or pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, metastasis invading the GI tract, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques.
•7. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
+16 more criteria

Locations (9)

ASST degli Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

IRCCS Ospedale Policlinico San Martino, Genova

Genova, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda ospedaliera di Padova

Padua, Italy

Azienda Ospedaliero - Universitaria di Parma

Parma, Italy

University Hospital of Geneva

Geneva, Switzerland

University Hospital Zurich

Zurich, Switzerland

Key Dates

Start Date

August 7, 2025

Primary Completion Date

June 1, 2028

Completion Date

January 1, 2029

Last Updated

December 18, 2025

Enrollment

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer NSCLC

Interventions

Durvalumab (MEDI4736)

DRUG

Ceralasertib

DRUG

radiotherapy

RADIATION

Contacts

Irene De Simone, Project manager

CONTACT

+39 02 39014661 irene.desimone@marionegri.it