A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC

Sponsor
Shandong Cancer Hospital and Institute
Study ID
NCT04982549
Phase
PHASE2
Status
Unknown

Conditions

  • Unresectable Stage III NSCLC

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab (intravenous infusion)
  • Carboplatin/ Paclitaxel — DRUG
    Carboplatin /Paclitaxel, as per standard of care
  • Pemetrexed/ Cisplatin — DRUG
    Pemetrexed / Cisplatin, as per standard of care
  • Pemetrexed/ Carboplatin — DRUG
    Pemetrexed / Carboplatin , as per standard of care
  • Radiation — RADIATION
    5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Study Details

This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Key Dates

Start date
Jan 21, 2021
Status verified
Aug 2021
Primary completion
Dec 1, 2022
Completion
Mar 1, 2023

Study Design

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

Arms

  • Experimental: Durvalumab + platinum-based chemotherapy and radiation
    All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.

Primary Outcome Measure

Grade ≥3 immune-mediated Adverse event [ Time Frame: From the date of first dose until disease progression,assessed up to 4 years ]

Central Contacts