Neoadjuvant Immunotherapy With Durvalumab (MEDI4736) in Non-Surgical Early Stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Followed by Radical Radiotherapy or Chemoradiotherapy

Sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Study ID
NCT05267392
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Patients will receive 1500 mg of durvalumab (MEDI4736) via IV infusion
  • standard of care RT/RCT — OTHER
    standard of care RT/RCT

Study Details

This study proposes to evaluate the safety and efficacy of an anti-PD-L1 (durvalumab) agent as neoadjuvant therapy in patients diagnosed with localized NSCLC who are planned to undergo radical RT or CRT. The hypothesis to be tested for the primary objective is that the treatment of durvalumab followed by RT/CRT will be safe and well tolerated in subjects with NSCLC.

Key Dates

Start date
Feb 16, 2021
Status verified
Dec 2021
Primary completion
Jul 31, 2023
Completion
Jan 31, 2024

Study Design

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

Arms

  • Experimental: Durvalumab
    All subjects enrolled in the study will receive open-label neoadjuvant durvalumab 1500 mg followed by standard of care RT/RCT

Primary Outcome Measure

Incidence of Dose-Limiting Toxicity (DLT) [ Time Frame: Through study development up to 5 - 6 weeks after the last session of RT/CRT for each enrolled patient ]

Central Contacts

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