History of Changes for Study: NCT02125461

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC)

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Study Record Versions

Version	Submitted Date	Changes
1	April 25, 2014	None (earliest Version on record)
2	May 20, 2014	Recruitment Status, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Oversight
3	June 4, 2014	Study Status and References
4	August 19, 2014	Contacts/Locations, Study Status and Study Design
5	September 15, 2014	Contacts/Locations and Study Status
6	November 19, 2014	Contacts/Locations and Study Status
7	December 19, 2014	Contacts/Locations and Study Status
8	January 28, 2015	Contacts/Locations, Study Status and Arms and Interventions
9	March 25, 2015	Study Status
10	May 29, 2015	Contacts/Locations, Study Status and Outcome Measures
11	June 29, 2015	Contacts/Locations and Study Status
12	July 27, 2015	Contacts/Locations and Study Status
13	July 28, 2015	Study Status
14	August 18, 2015	Study Status and Contacts/Locations
15	September 11, 2015	Contacts/Locations and Study Status
16	October 20, 2015	Contacts/Locations, Study Status and Eligibility
17	November 16, 2015	Contacts/Locations and Study Status
18	December 15, 2015	Contacts/Locations and Study Status
19	January 11, 2016	Contacts/Locations and Study Status
20	February 11, 2016	Contacts/Locations and Study Status
21	April 7, 2016	Recruitment Status, Contacts/Locations, Study Status and Outcome Measures
22	July 1, 2016	Contacts/Locations and Study Status
23	September 1, 2016	Study Status and Contacts/Locations
24	November 25, 2016	Study Status and Contacts/Locations
25	February 24, 2017	Study Status and Study Design
26	May 1, 2017	Study Status, Contacts/Locations, Oversight and Study Design
27	May 11, 2017	Study Status and Study Design
28	June 22, 2017	Contacts/Locations, Study Status and Study Design
29	January 12, 2018	Contacts/Locations, Study Status
	Results Submission Events
February 13, 2018 April 6, 2018 June 5, 2018 August 28, 2018 November 9, 2018 January 3, 2019		Returned after QC review: March 12, 2018 Returned after QC review: May 10, 2018 Returned after QC review: July 13, 2018 Returned after QC review: September 27, 2018 Returned after QC review: December 4, 2018 (Canceled on January 28, 2019)
30	January 28, 2019	Contacts/Locations, Outcome Measures, Study Status, Document Section, Results and References
31	March 20, 2019	Outcome Measures, Adverse Events, Participant Flow, Document Section, Baseline Characteristics, Study Status, More Information and Contacts/Locations
32	June 21, 2019	Contacts/Locations and Study Status
33	September 16, 2019	Study Status and Contacts/Locations
34	December 17, 2019	Contacts/Locations and Study Status
35	March 18, 2020	Contacts/Locations and Study Status
36	September 3, 2020	Study Status, IPDSharing and Contacts/Locations
37	May 11, 2021	Contacts/Locations and Study Status
38	September 6, 2021	Contacts/Locations and Study Status
39	November 3, 2021	Adverse Events, Participant Flow, Outcome Measures, Document Section, More Information, References, Study Status and Contacts/Locations
40	January 17, 2022	Study Status
41	April 12, 2022	Study Status
42	August 16, 2022	Contacts/Locations and Study Status
43	November 9, 2022	Study Status
44	January 4, 2023	Study Status
45	April 5, 2023	Study Status
46	June 28, 2023	Study Status and Study Identification
47	September 21, 2023	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	D4191C00001
Brief Title:	A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC)
Official Title:	A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
Secondary IDs:

Study Status


Record Verification:	April 2014
Overall Status:	Not yet recruiting
Study Start:	May 2014
Primary Completion:	May 2017 [Anticipated]
Study Completion:	July 2019 [Anticipated]

First Submitted:	April 25, 2014
First Submitted that Met QC Criteria:	April 25, 2014
First Posted:	April 29, 2014 [Estimate]

Last Update Submitted that Met QC Criteria:	April 25, 2014
Last Update Posted:	April 29, 2014 [Estimate]

Sponsor/Collaborators


Sponsor:	AstraZeneca
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description


Brief Summary:	A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
Detailed Description:	A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

Conditions


Conditions:	Non-Small Cell Lung Cancer
Keywords:	Locally advanced Unresectable Non-Small Cell Lung Cancer MEDI4736 PD-L1 Stage III Non-Small Cell Lung Cancer Chemoradiation Immune-mediated cancer therapy

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	880 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: MEDI4736 MEDI4736 (intravenous infusion)	Drug: MEDI4736 MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Placebo Comparator: PLACEBO Placebo (matching placebo for intravenous infusion)	PLACEBO PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier

Outcome Measures


Primary Outcome Measures:
1.	Overall Survival (OS) [ Time Frame: Estimated to be from baseline up to 5 years ] Overall Survival is defined as the time from the date of randomization until death due to any cause.
2.	Progression Free Survival (PFS) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be from baseline up to 5 years ] Progression-Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
Secondary Outcome Measures:
1.	Overall Survival at 24 months (OS24) [ Time Frame: Estimated to be from baseline up to 5 years ] OS24 is defined as the number (%) of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months.
2.	Duration of Response (DoR) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] DoR is defined as the time from date for first documented response of Complete Response (CR) or Partial Response (PR) until the first documented response of progression per RECIST 1.1 or death in the absence of progression.
3.	Objective Response Rate (ORR) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] ORR is defined as the number (%) of patients with at least one visit response of Complete Response (CR) or partial response (PR) per RECIST 1.1.
4.	Proportion of patients alive and progression free at 12 months from (APF12) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] APF12 is defined as the number (%) of patietns who are alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of progression free survival at 12 months.
5.	Proportion of patients alive and progression free at 18 months from(APF18) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] APF18 is defined as the number (%) of patients who are alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of progression free survival at 18 months.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Age at least 18 years. Documented evidence of NSCLC (locally advanced, unresectable, Stage III) Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. World Health Organisation (WHO) Performance Status of 0 to 1. Esitmated life expectancy of more than 12 weeks. Exclusion Criteria: Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. Active or prior autoimmune disease or history of immunodeficiency. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).

Contacts/Locations


Central Contact Person:	AstraZeneca Clinical Study Information Telephone: 800-236-9933 Email: ClinicalTrialTransparency@astrazeneca.com
Study Officials:	Giovanni Melillo, MD Study Director AstraZeneca
Locations:

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: