CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 166 enrolled
Drug / intervention
Durvalumab plus chemotherapydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04449861
NCT04449861Phase 3Completed
CompareCT.gov

An Open Label, Multicenter Study of First-Line Durvalumab Plus Platinum-Based Chemotherapy in Chinese Patients With Extensive Stage Small-Cell Lung Cancer (Oriental)

AstraZeneca·interventional·Posted Jun 29, 2020·Updated Nov 27, 2024

In Brief

A Phase 3 clinical trial evaluating Durvalumab plus chemotherapy for Small Cell Lung Carcinoma Extensive Disease. Completed, enrolled 166 participants across 30 sites.

Detailed Summary

This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Carcinoma Extensive Disease
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 29, 2020
Enrollment StartDec 7, 2020
Primary CompletionMar 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago

Interventions

Durvalumab plus chemotherapydrug

Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Carboplatin 4-6 cycles every 3 weeks Drug: Cisplatin 4-6 cycles every 3 weeks Drug: Etoposide 4-6 cycles every 3 weeks