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

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT06680050
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non Small Cell Lung Cancer NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab (MEDI4736) — DRUG
    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.
  • Ceralasertib — DRUG
    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.
  • radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Aug 7, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy followed by Durvalumab+Ceralasertib

Primary Outcome Measure

Safety and tolerability, in terms of number of grade 3 or higher adverse events judged as at least possibly related to study treatment regimen [ Time Frame: within 6 months from the start of study treatment ]

Central Contacts