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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02453282




Registration number
NCT02453282
Ethics application status
Date submitted
20/05/2015
Date registered
25/05/2015
Date last updated
2/06/2020

Titles & IDs
Public title
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).
Scientific title
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)
Secondary ID [1] 0 0
D419AC00001
Universal Trial Number (UTN)
Trial acronym
MYSTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Carcinoma NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MEDI4736 (Durvalumab)
Other interventions - MEDI4736 (Durvalumab)+Tremelimumab
Treatment: Drugs - Paclitaxel + Carboplatin
Treatment: Drugs - Gemcitabine + Cisplatin
Treatment: Drugs - Gemcitabine + Carboplatin
Treatment: Drugs - Pemetrexed + Cisplatin
Treatment: Drugs - Pemetrexed + Carboplatin
Other interventions - Tremelimumab

Experimental: Monotherapy - PD-L1 monoclonal Antibody monotherapy.

Experimental: Combination Therapy - PD-L1+Tremelimumab combination therapy

Active Comparator: Standard of Care - Standard of Care chemotherapy treatment


Other interventions: MEDI4736 (Durvalumab)


Other interventions: MEDI4736 (Durvalumab)+Tremelimumab


Treatment: Drugs: Paclitaxel + Carboplatin
Chemotherapy Agents

Treatment: Drugs: Gemcitabine + Cisplatin
Chemotherapy Agents

Treatment: Drugs: Gemcitabine + Carboplatin
Chemotherapy Agents

Treatment: Drugs: Pemetrexed + Cisplatin
Chemotherapy Agents

Treatment: Drugs: Pemetrexed + Carboplatin
Chemotherapy Agents

Other interventions: Tremelimumab


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy - The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Timepoint [1] 0 0
From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Primary outcome [2] 0 0
Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy - The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Timepoint [2] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [1] 0 0
OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy - The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Timepoint [1] 0 0
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [2] 0 0
OS; PD-L1 (TC >=1%) Analysis Set Population - The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Timepoint [2] 0 0
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [3] 0 0
OS; FAS Population - The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Timepoint [3] 0 0
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [4] 0 0
PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy - The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Timepoint [4] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [5] 0 0
PFS; PD-L1 (TC >=1%) Analysis Set Population - The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Timepoint [5] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [6] 0 0
PFS; FAS Population - The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Timepoint [6] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [7] 0 0
Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population - The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Timepoint [7] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [8] 0 0
ORR; PD-L1 (TC >=1%) Analysis Set Population - The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Timepoint [8] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [9] 0 0
ORR; FAS Population - The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Timepoint [9] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [10] 0 0
Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population - The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Timepoint [10] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [11] 0 0
DoR; PD-L1 (TC >=1%) Analysis Set Population - The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Timepoint [11] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [12] 0 0
DoR; FAS Population - The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Timepoint [12] 0 0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Secondary outcome [13] 0 0
Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population - The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Timepoint [13] 0 0
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Secondary outcome [14] 0 0
Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population - The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Timepoint [14] 0 0
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Secondary outcome [15] 0 0
Percentage of Participants APF12; FAS Population - The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Timepoint [15] 0 0
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Secondary outcome [16] 0 0
Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population - The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Timepoint [16] 0 0
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Secondary outcome [17] 0 0
PFS2; PD-L1 (TC >=1%) Analysis Set Population - The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Timepoint [17] 0 0
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Secondary outcome [18] 0 0
PFS2; FAS Population - The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Timepoint [18] 0 0
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Secondary outcome [19] 0 0
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months - Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items with higher scores representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change is defined as an absolute change in the score from baseline of >=10.
Timepoint [19] 0 0
At baseline then every 4 weeks for the first 8 weeks relative to the date of randomization, then every 8 weeks until second progression/death, whichever comes first. Assessed up to 12 months.
Secondary outcome [20] 0 0
Serum Concentrations of Durvalumab - Blood samples were collected to determine the serum concentration of durvalumab.
Timepoint [20] 0 0
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.
Secondary outcome [21] 0 0
Serum Concentrations of Tremelimumab - Blood samples were collected to determine the serum concentration of tremelimumab.
Timepoint [21] 0 0
Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.
Secondary outcome [22] 0 0
Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab - Blood samples were collected to determine the Cmax_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Timepoint [22] 0 0
Within 1 hour after end of infusion on infusion day at Week 12.
Secondary outcome [23] 0 0
Cmax_ss of Tremelimumab - Blood samples were collected to determine the Cmax_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Timepoint [23] 0 0
Within 1 hour after end of infusion on infusion day at Week 12.
Secondary outcome [24] 0 0
Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab - Blood samples were collected to determine the Ctrough_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Timepoint [24] 0 0
Pre-dose at Week 12.
Secondary outcome [25] 0 0
Ctrough_ss of Tremelimumab - Blood samples were collected to determine the Ctrough_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Timepoint [25] 0 0
Pre-dose at Week 12.
Secondary outcome [26] 0 0
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab - Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against durvalumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Timepoint [26] 0 0
At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.
Secondary outcome [27] 0 0
Number of Participants With ADA Response to Tremelimumab - Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against tremelimumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Timepoint [27] 0 0
At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

Eligibility
Key inclusion criteria
For inclusion in the study, patients should fulfill the following criteria:

- Aged at least 18 years

- Documented evidence of Stage IV NSCLC

- No sensitizing EGFR mutation or ALK rearrangement

- No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

- World Health Organization (WHO) Performance Status of 0 or 1
Minimum age
18 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are
fulfilled:

1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable
(not requiring steroids)

3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other
anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
(PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
excluding therapeutic anticancer vaccines

4. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn's disease]

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Gosford
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Port Macquarie
Recruitment hospital [6] 0 0
Research Site - Southport
Recruitment hospital [7] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels
Country [20] 0 0
Belgium
State/province [20] 0 0
Charleroi
Country [21] 0 0
Belgium
State/province [21] 0 0
Duffel
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Belgium
State/province [23] 0 0
Liège
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Saskatchewan
Country [26] 0 0
France
State/province [26] 0 0
Bordeaux Cedex
Country [27] 0 0
France
State/province [27] 0 0
Brest Cedex
Country [28] 0 0
France
State/province [28] 0 0
Creteil
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
State/province [30] 0 0
Lyon Cedex 08
Country [31] 0 0
France
State/province [31] 0 0
Marseille cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Aachen
Country [33] 0 0
Germany
State/province [33] 0 0
Bad Berka
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Freiburg
Country [36] 0 0
Germany
State/province [36] 0 0
Gauting
Country [37] 0 0
Germany
State/province [37] 0 0
Hamburg
Country [38] 0 0
Germany
State/province [38] 0 0
Heidelberg
Country [39] 0 0
Germany
State/province [39] 0 0
Hemer
Country [40] 0 0
Germany
State/province [40] 0 0
Homburg/Saar
Country [41] 0 0
Germany
State/province [41] 0 0
Immenhausen
Country [42] 0 0
Germany
State/province [42] 0 0
Lubeck
Country [43] 0 0
Germany
State/province [43] 0 0
Löwenstein
Country [44] 0 0
Germany
State/province [44] 0 0
Mainz
Country [45] 0 0
Germany
State/province [45] 0 0
Münster
Country [46] 0 0
Germany
State/province [46] 0 0
Oldenburg
Country [47] 0 0
Germany
State/province [47] 0 0
Ulm
Country [48] 0 0
Germany
State/province [48] 0 0
Velbert
Country [49] 0 0
Germany
State/province [49] 0 0
Würzburg
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Deszk
Country [52] 0 0
Hungary
State/province [52] 0 0
Edelény
Country [53] 0 0
Hungary
State/province [53] 0 0
Kaposvár
Country [54] 0 0
Hungary
State/province [54] 0 0
Kecskemét
Country [55] 0 0
Hungary
State/province [55] 0 0
Miskolc
Country [56] 0 0
Hungary
State/province [56] 0 0
Nyíregyháza
Country [57] 0 0
Hungary
State/province [57] 0 0
Pécs
Country [58] 0 0
Hungary
State/province [58] 0 0
Székesfehérvár
Country [59] 0 0
Italy
State/province [59] 0 0
Genova
Country [60] 0 0
Italy
State/province [60] 0 0
Meldola
Country [61] 0 0
Italy
State/province [61] 0 0
Milano
Country [62] 0 0
Italy
State/province [62] 0 0
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Japan
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Japan
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Hirosaki-shi
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Japan
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Iizuka-shi
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Japan
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Iwakuni-shi
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Japan
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Vietnam
State/province [141] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the
efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal
growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced
or metastatic NSCLC
Trial website
https://clinicaltrials.gov/show/NCT02453282
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart McIntosh, MD
Address 0 0
AstraZeneca, Alderley Park, Cheshire, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications