Study of AZD2811 + Durvalumab in ES-SCLC

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
AstraZeneca
Study ID
NCT04745689
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Small-Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    IV infusions through induction phase. IV infusions through maintenance phase until PD or other discontinuation criteria.
  • AZD2811 — DRUG
    IV infusions through maintenance phase until PD or other discontinuation criteria.
  • Carboplatin — DRUG
    IV infusions through induction phase if chosen by Investigator.
  • Cisplatin — DRUG
    IV infusions through induction phase if chosen by Investigator.
  • Etoposide — DRUG
    IV infusions through induction phase.

Study Details

A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.

Key Dates

Start date
Feb 23, 2021
Status verified
Apr 2026
Primary completion
Jun 18, 2022
Completion
Dec 1, 2026

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AZD2811 + Durvalumab
    Induction: Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin \& Etoposide) Maintenance: AZD2811 + Durvalumab

Primary Outcome Measure

Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy] [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteGrand RapidsMichigan49503-

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