Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer

Sponsor
AstraZeneca
Study ID
NCT04774380
Phase
PHASE3
Status
Completed

Conditions

  • Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Participants will receive durvalumab via IV infusion on Day 1 of each cycle.
  • Cisplatin — DRUG
    Participants will receive cisplatin via IV administration on Day 1 of each cycle.
  • Carboplatin — DRUG
    Participants will receive carboplatin via IV administration Day 1 of each cycle.
  • Etoposide — DRUG
    Participants will receive etoposide via IV administration on days 1 to 3 of each cycle.

Study Details

Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.

Key Dates

Start date
Nov 11, 2021
Status verified
May 2025
Primary completion
Jun 12, 2023
Completion
Jan 2, 2025

Study Design

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

Arms

  • Experimental: Durvalumab - (cisplatin or carboplatin) - Etoposide
    Participants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met.

Primary Outcome Measure

Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs) [ Time Frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years. ]

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