MedTrace Logo

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

NCT03800134 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2025-06-11

No results posted yet for this study

Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Conditions

Interventions

DRUG

Durvalumab

1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

OTHER

Placebo

Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

DRUG

Carboplatin

Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles

DRUG

Cisplatin

75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles

DRUG

Pemetrexed

500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

DRUG

Paclitaxel

200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

DRUG

Gemcitabine

1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.

PROCEDURE

Surgery

Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Sponsors & Collaborators

Principal Investigators

  • John Heymach, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2022-11-10
Completion
2028-09-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Costa Rica
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800134 on ClinicalTrials.gov