RecruitingPhase 2NCT06680050

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


Sponsor

Mario Negri Institute for Pharmacological Research

Enrollment

21 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a DNA-damage repair blocking drug (ceralasertib) to a standard immunotherapy drug (durvalumab) plus targeted radiation improves outcomes for people with locally advanced lung cancer who relapsed after completing the standard PACIFIC treatment regimen. **You may be eligible if...** - You are 18 or older with locally advanced non-small cell lung cancer (NSCLC) that came back after the PACIFIC treatment (durvalumab maintenance) - You have been on durvalumab maintenance for at least 3 months - The cancer has progressed in your chest, with or without up to 3 other tumor spots that can be targeted with radiation - You are well enough to receive treatment (ECOG performance status 0–2) - Your relapse occurred more than 12 months after completing the first course of chest radiation **You may NOT be eligible if...** - Your cancer has spread widely beyond 3 other sites - You are not well enough to tolerate treatment - You weigh less than 30 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab (MEDI4736)

Durvalumab will be administered via IV infusion at a dose of 1500 mg on day 8 Q4W until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

DRUGCeralasertib

Ceralasertib dose will be administered orally, 240mg BID, approximately 12 ± 2 hours apart, days 1 to 7 q28 (Q4W), up to progression or unacceptable toxicity.

RADIATIONradiotherapy

Loco-regional recurrences of the primary tumor and regional lymph node metastases will be treated with a total dose of 36 to 50 Gy in daily fractions with a dose of 2 to 3 Gy per fraction. Two weeks from the last dose of radiotherapy, a systemic treatment with durvalumab and ceralasertib will be started.


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

Padova, Italy

Azienda Ospedaliero - Universitaria di Parma

Parma, Italy

University Hospital of Geneva

Geneva, Switzerland

University Hospital Zurich

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06680050