Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital

About this trial

Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.

Eligibility criteria

Qualifiers

Age ≥18 years at time of study entry

Histologically documented diagnosis of unresectable stage III NSCLC;

Fully-informed written consent obtained from patients;

Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1;

Disqualifiers

Previous chemo-, immuno- or radiotherapy for NSCLC

Major surgical procedure last 28 days

History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV

Uncontrolled intercurrent illness

Trial design

Treatments tested in this trial

  • standar thoracic RT dose
  • decreased thoracic RT dose

Treatment groups

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators