Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

Sponsor
AstraZeneca
Study ID
NCT03519971
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous infusion)
  • Placebo — OTHER
    Placebo IV (intravenous infusion)
  • Cisplatin/ Etoposide — DRUG
    Cisplatin/ Etoposide, as per standard of care
  • 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 Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care \[SoC\] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Key Dates

Start date
Mar 29, 2018
Status verified
Oct 2025
Primary completion
Sep 7, 2023
Completion
Dec 1, 2025

Study Design

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

Arms

  • Experimental: Arm 1: Durvalumab + platinum-based chemotherapy and radiation
    Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. 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.
  • Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy and radiation
    Placebo in concurrence with platinum-based chemo-radiation therapy. 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 placebo as consolidation treatment.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

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