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Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Placebo
Cisplatin/ Etoposide
Carboplatin/ Paclitaxel
Pemetrexed/ Cisplatin
Pemetrexed/ Carboplatin
Radiation
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Locally Advanced, Unresectable NSCLC, Carcinoma, NSCLC

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Principal inclusion criteria :

  • Subjects with histologically- or cytologically-documented NSCLC
  • Locally advanced, unresectable (Stage III) NSCLC
  • World Health Organisation (WHO) performance status 0-1
  • At least one measurable lesion, not previously irradiated
  • Must have a life expectancy of at least 12 weeks at randomization

Principal exclusion criteria :

  • Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
  • Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.
  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness
  • History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
  • Mixed small cell and NSCLC histology
  • Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling
  • Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
  • Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving β‰₯20 Gy in total (V20) of more than 35% of lung volume.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: Durvalumab + platinum-based chemotherapy and radiation

Arm 2: Placebo + platinum-based chemotherapy and radiation

Arm Description

Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.

Placebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Overall Survival (OS)
Objective Response Rate (ORR)
Overall Survival at 24 months
Rate of complete response
Duration of response (DoR)
Disease Control Rate (DCR)
Time from randomization to second progression PFS2
Time to death or distant metastasis (TTDM)
Presence of ADA for durvalumab in combination with CRT
To assess symptoms and health-related QoL in patients treated with durvalumab + SoC CRT compared with placebo + SoC CRT using EORTC QLQ-C30 v3
To assess symptoms and health-related QoL in patients treated with durvalumab + SoC CRT compared with placebo + SoC CRT using QLQ-LC13
To assess the PK of durvalumab in blood (peak trough concentration) when in combination with CRT

Full Information

First Posted
March 23, 2018
Last Updated
September 18, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03519971
Brief Title
Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer
Official Title
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently With Platinum-based Chemoradiation Therapy in Patients With Locally Advanced, Unresectable NSCLC (Stage III) (PACIFIC2)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
September 7, 2023 (Actual)
Study Completion Date
September 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Locally Advanced, Unresectable NSCLC, Carcinoma, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Durvalumab + platinum-based chemotherapy and radiation
Arm Type
Experimental
Arm Description
Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
Arm Title
Arm 2: Placebo + platinum-based chemotherapy and radiation
Arm Type
Placebo Comparator
Arm Description
Placebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab IV (intravenous infusion)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo IV (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Cisplatin/ Etoposide
Intervention Description
Cisplatin/ Etoposide, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Carboplatin/ Paclitaxel
Intervention Description
Carboplatin /Paclitaxel, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/ Cisplatin
Intervention Description
Pemetrexed / Cisplatin, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/ Carboplatin
Intervention Description
Pemetrexed / Carboplatin , as per standard of care
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
5 fractions/ week for ~6 weeks (Β±3 days) (Total 60 Gy)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
From date of randomization until the date of objective disease progression or death, assessed up to 4 years.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
From the date of randomization until death due to any cause, assessed up to 4 years.
Title
Objective Response Rate (ORR)
Time Frame
From the date of Randomisaton until the date of objective disease progression or death, assessed up to 4 years
Title
Overall Survival at 24 months
Time Frame
From the date of randomization until 24 months
Title
Rate of complete response
Time Frame
From the date of Randomisaton until the date of objective disease progression or death, assessed up to 4 years
Title
Duration of response (DoR)
Time Frame
From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 4 years.
Title
Disease Control Rate (DCR)
Time Frame
From the date of randomization until 24 weeks.
Title
Time from randomization to second progression PFS2
Time Frame
From the date of randomization to the earliest progression event subsequent to that used for the PFS endpoint or death, up to 4 years
Title
Time to death or distant metastasis (TTDM)
Time Frame
From the date of randomization to until the first date of distant metastasis or death in the absence of distant metastasis, assessed up to 4 years
Title
Presence of ADA for durvalumab in combination with CRT
Time Frame
From the date of randomization until 6 months after date of last IP dose.
Title
To assess symptoms and health-related QoL in patients treated with durvalumab + SoC CRT compared with placebo + SoC CRT using EORTC QLQ-C30 v3
Time Frame
From the date of randomisation until PFS2.
Title
To assess symptoms and health-related QoL in patients treated with durvalumab + SoC CRT compared with placebo + SoC CRT using QLQ-LC13
Time Frame
From the date of randomisation until PFS2.
Title
To assess the PK of durvalumab in blood (peak trough concentration) when in combination with CRT
Time Frame
From the date of randomization until 3 months after date of last IP dose.
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
From the date of randomization until disease progression, assessed up to 4 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Principal inclusion criteria : Subjects with histologically- or cytologically-documented NSCLC Locally advanced, unresectable (Stage III) NSCLC World Health Organisation (WHO) performance status 0-1 At least one measurable lesion, not previously irradiated Must have a life expectancy of at least 12 weeks at randomization Principal exclusion criteria : Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs. Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines. History of allogeneic organ transplantation Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus Mixed small cell and NSCLC histology Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving β‰₯20 Gy in total (V20) of more than 35% of lung volume.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bradley, MD
Organizational Affiliation
AstraZeneca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Research Site
City
FlorianΓ³polis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60336-045
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
RibeirΓ£o Preto
ZIP/Postal Code
14021-636
Country
Brazil
Facility Name
Research Site
City
RibeirΓ£o Preto
ZIP/Postal Code
14048900
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Research Site
City
SΓ£o JosΓ© do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
703 00
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Research Site
City
GyΕ‘r
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
TΓΆrΓΆkbΓ‘lint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560068
Country
India
Facility Name
Research Site
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Karamsad
ZIP/Postal Code
388325
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400053
Country
India
Facility Name
Research Site
City
Nasik
ZIP/Postal Code
422005
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110063
Country
India
Facility Name
Research Site
City
Vadodara
ZIP/Postal Code
390007
Country
India
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Research Site
City
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Gyeongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
0 3100
Country
Mexico
Facility Name
Research Site
City
MΓ©rida
ZIP/Postal Code
97134
Country
Mexico
Facility Name
Research Site
City
MΓ©xico
ZIP/Postal Code
04700
Country
Mexico
Facility Name
Research Site
City
Orizaba
ZIP/Postal Code
94300
Country
Mexico
Facility Name
Research Site
City
La Libertad
ZIP/Postal Code
13013
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 41
Country
Peru
Facility Name
Research Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Research Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Research Site
City
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Research Site
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1015
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Taguig City
ZIP/Postal Code
1634
Country
Philippines
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Research Site
City
ElblΔ…g
ZIP/Postal Code
02-300
Country
Poland
Facility Name
Research Site
City
GdaΕ„sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115533
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Research Site
City
Rostov-on-Don
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Mueang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Research Site
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34030
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh city
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

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