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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research

About this trial

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 criteria

Qualifiers

Provision of signed, written and dated informed consent and any locally required authorization

Male or female aged 18 years or older

ECOG Performance Status of 0-2

Life expectancy ≥ 6 months at the start of treatment

Disqualifiers

Patients who discontinued durvalumab due to local or systemic progression during the maintenance phase < 12 months after the end of CRT

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.

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

Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

Trial design

Treatments tested in this trial

  • Durvalumab (MEDI4736)
  • Ceralasertib
  • radiotherapy

Treatment groups

21 Participants
are divided into 1 treatment group