Phase II Study of Radiotherapy Followed by Durvalumab (MEDI4736) and Ceralasertib (AZD6738) in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen (AUSTRAL)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2028

Conditions
Non Small Cell Lung Cancer NSCLC
Interventions
DRUG

Durvalumab (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.

DRUG

Ceralasertib

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.

RADIATION

radiotherapy

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.

Trial Locations (9)

Unknown

ASST degli Spedali Civili di Brescia, Brescia

Azienda Ospedaliero Universitaria Careggi, Florence

IRCCS Ospedale Policlinico San Martino, Genova, Genova

ASST Grande Ospedale Metropolitano Niguarda, Milan

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

Azienda ospedaliera di Padova, Padua

Azienda Ospedaliero - Universitaria di Parma, Parma

University Hospital of Geneva, Geneva

University Hospital Zurich, Zurich

All Listed Sponsors
lead

Mario Negri Institute for Pharmacological Research

OTHER