A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02125461 |
Recruitment Status :
Completed
First Posted : April 29, 2014
Results First Posted : January 30, 2019
Last Update Posted : October 10, 2023
|
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Non-Small Cell Lung Cancer |
Interventions |
Drug: MEDI4736 Other: PLACEBO |
Enrollment | 713 |
Participant Flow
Recruitment Details | Patients were randomized between 09 May 2014 and 22 Apr 2016 in 235 study centers across 26 countries. Data cut-off (DCO) date for analysis of progression-free survival (PFS) and PFS rates at 12 and 18 months: 13 Feb 2017; DCO date for analysis of overall survival (OS) and all other secondary outcome measures: 22 Mar 2018; DCO date for completion of long-term survival: 11 Jan 2021. |
Pre-assignment Details | Eligible patients with locally advanced, unresectable Stage III non-small cell lung cancer were randomized in a 2:1 ratio to receive either durvalumab (MEDI4736) 10 milligrams (mg) / kilogram (kg) every 2 weeks (Q2W) or placebo. |
Arm/Group Title | Durvalumab (MEDI4736) | Placebo |
---|---|---|
Arm/Group Description | Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months. | Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. |
Period Title: Overall Study | ||
Started [1] | 476 | 237 |
Full Analysis Set (FAS) | 476 | 237 |
Received Treatment | 473 | 236 |
Safety Analysis Set | 475 | 234 |
Completed 12 Months of Treatment | 232 | 82 |
Completed [2] | 178 | 68 |
Not Completed | 298 | 169 |
Reason Not Completed | ||
Withdrawal by Subject | 30 | 16 |
Lost to Follow-up | 8 | 3 |
Death | 260 | 149 |
Missing Termination Reason | 0 | 1 |
[1]
Randomized
[2]
Ongoing study at final DCO (study complete)
|
Baseline Characteristics
Arm/Group Title | Durvalumab (MEDI4736) | Placebo | Total | |
---|---|---|---|---|
Arm/Group Description | Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months. | Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. | Total of all reporting groups | |
Overall Number of Baseline Participants | 476 | 237 | 713 | |
Baseline Analysis Population Description |
Baseline analysis was based on the FAS consisting of all randomized patients.
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 476 participants | 237 participants | 713 participants | |
63.0 (8.66) | 62.6 (9.64) | 62.9 (8.99) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 476 participants | 237 participants | 713 participants | |
Female |
142 29.8%
|
71 30.0%
|
213 29.9%
|
|
Male |
334 70.2%
|
166 70.0%
|
500 70.1%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 476 participants | 237 participants | 713 participants |
White |
337 70.8%
|
157 66.2%
|
494 69.3%
|
|
Black or African American |
12 2.5%
|
2 0.8%
|
14 2.0%
|
|
Asian |
120 25.2%
|
72 30.4%
|
192 26.9%
|
|
Native Hawaiian or Pacific Islander |
1 0.2%
|
1 0.4%
|
2 0.3%
|
|
American Indian or Alaska Native |
4 0.8%
|
5 2.1%
|
9 1.3%
|
|
Other |
1 0.2%
|
0 0.0%
|
1 0.1%
|
|
Missing |
1 0.2%
|
0 0.0%
|
1 0.1%
|
|
Smoking History
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 476 participants | 237 participants | 713 participants | |
Non-smoker |
43 9.0%
|
21 8.9%
|
64 9.0%
|
|
Ex-smoker |
354 74.4%
|
178 75.1%
|
532 74.6%
|
|
Current smoker |
79 16.6%
|
38 16.0%
|
117 16.4%
|
Outcome Measures
Adverse Events
Limitations and Caveats
Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.
More Information
Results Point of Contact
Name/Title: | Global Clinical Lead |
Organization: | AstraZeneca |
Phone: | 1-877-240-9479 |
EMail: | information.center@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02125461 |
Other Study ID Numbers: |
D4191C00001 2014-000336-42 ( EudraCT Number ) |
First Submitted: | April 25, 2014 |
First Posted: | April 29, 2014 |
Results First Submitted: | February 13, 2018 |
Results First Posted: | January 30, 2019 |
Last Update Posted: | October 10, 2023 |