Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT04351256
Phase
PHASE2
Status
Completed

Conditions

  • NSCLC, Stage III

Eligibility Criteria

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

Interventions

  • Durvalumab Injection [Imfinzi] — DRUG
    Durvalumab fixed dose of 1,500 mg
  • Thoracic Radiotherapy (TRT) conventionally — RADIATION
    Conventionally fractionated TRT consisting of 30 x 2 Gy (60 Gy) within 6 weeks
  • Thoracic Radiotherapy (TRT) hypofractionated — RADIATION
    Hypofractionated TRT consisting of 20 x 2,75 Gy (55 Gy) within 4 weeks

Study Details

This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).

Key Dates

Start date
May 20, 2020
Status verified
Mar 2026
Primary completion
Jan 21, 2026
Completion
Jan 21, 2026

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (HYPO group)
    * Durvalumab at a fixed dose of 1,500 mg as an IV infusion over 1 hour, on day 1, to be repeated every 4 weeks (Q4W) for a maximum of 12 cycles * Thoracic radiation therapy (TRT): hypofractionated thoracic radiotherapy consisting of 20 x 2,75 Gy (55 Gy) within 4 weeks (+9 days)
  • Active Comparator: Arm B (CON group)
    * Durvalumab at a fixed dose of 1,500 mg as an IV infusion over 1 hour, on day 1, to be repeated every 4 weeks (Q4W) for a maximum of 12 cycles * Thoracic radiation therapy (TRT): conventional fractions of 30 x 2 Gy (60 Gy) within 6 weeks (+9 days)

Primary Outcome Measure

Toxicity (pneumonitis) [ Time Frame: up to 35 months ]

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