NCT04441138

Chemoradiation Followed by Durvalumab in Poor Risk and/or Elderly Patients With Stage III NSCLC

Phase II Trial of Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Elderly (age 70 years or older) or \>18 years old AND poor risk (ECOG 2) newly diagnosed stage IIIA-C (AJCC 8th edition) inoperable non-small cell lung cancer (NSCLC) patients are eligible to participate in this phase II open label study of concurrent, split course chemoradiation followed by Durvalumab (MEDI4736).

Detailed description

The rationale for the study is to identify another cohort of stage III NSCLC for whom adjuvant Durvalumab can be safely given, expanding its utilization and benefits. With a unique, extremely well-tolerated 4-phase split course CRT regimen preceding the administration of Durvalumab, we expect to be able to offer adjuvant Durvalumab to a significant proportion of patients on study. Patients who have completed four cycles of chemoradiation (Radiation is 60 Gy in 30 fractions administered over 12 weeks with 1-1.5 week breaks between cycles; Chemotherapy is once every 3 weeks for up to 4 cycles) will go on to receive durvalumab (MEDI4736) monotherapy as 1500mg durvalumab (MEDI4736) via IV infusion Q4W for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48 until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Primary objectives are: 1. To determine the percentage of poor risk and/or elderly unresectable stage III NSCLC patients who complete split course chemoradiation 2. To determine the safety and tolerability of durvalumab (MEDI4736) after completion of chemoradiation in this group of patients. Secondary Objectives are: 1. To determine the 1-year overall survival rate 2. To determine the 1-year progression-free survival rate 3. To determine the 1-year loco-regional progression-free survival rate 4. To determine rate of grade 3 and 4 toxicities with this regimen in the selected patient population

Conditions

• Stage III Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease

Timeline

• Start date: 2021-02-25
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2020-06-22
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study