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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02576574

Registration number

NCT02576574

Ethics application status

Date submitted

13/10/2015

Date registered

15/10/2015

Date last updated

25/03/2025

Titles & IDs

Public title

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Scientific title

A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

Secondary ID [1]

2015-001537-24

Secondary ID [2]

EMR 100070-005

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

First Line Non-Small Cell Lung Cancer

Condition category

Condition code

Cancer

Lung - Non small cell

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Avelumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Avelumab Weekly

Experimental: Avelumab Biweekly -

Experimental: Avelumab Weekly -

Active comparator: Chemotherapy -

Treatment: Drugs: Avelumab
Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.

Treatment: Drugs: Pemetrexed
Participants received Pemetrexed 500 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Paclitaxel
Participants received Paclitaxel 200 mg/m\^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Gemcitabine
Participants received Gemcitabine 1250 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Gemcitabine
Participants received Gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.

Treatment: Drugs: Carboplatin
Participants received Carboplatin area under concentration curve (AUC) 5 mg/mL\*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.

Treatment: Drugs: Cisplatin
Participants received Cisplatin 75 mg/m\^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Carboplatin
Carboplatin AUC 6 mg/mL\*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.

Treatment: Drugs: Avelumab Weekly
Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

Assessment method [1]

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Timepoint [1]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Primary outcome [2]

Assessment method [2]

Timepoint [2]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Primary outcome [3]

Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

Assessment method [3]

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Timepoint [3]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Primary outcome [4]

Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

Assessment method [4]

Timepoint [4]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [1]

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

Assessment method [1]

Timepoint [1]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [2]

Assessment method [2]

Timepoint [2]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [3]

Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

Assessment method [3]

Timepoint [3]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [4]

Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

Assessment method [4]

Timepoint [4]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [5]

Overall Survival (OS) in Full Analysis Set (FAS)

Assessment method [5]

Timepoint [5]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [6]

Overall Survival (OS) in Modified Full Analysis Set (mFAS)

Assessment method [6]

Timepoint [6]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [7]

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set

Assessment method [7]

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Timepoint [7]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [8]

Assessment method [8]

Timepoint [8]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [9]

Assessment method [9]

Timepoint [9]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [10]

Assessment method [10]

Timepoint [10]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [11]

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

Assessment method [11]

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Timepoint [11]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [12]

Assessment method [12]

Timepoint [12]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [13]

Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment

Assessment method [13]

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Timepoint [13]

Baseline, End of treatment (up to Week 283.9)

Secondary outcome [14]

Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

Assessment method [14]

Timepoint [14]

Baseline, End of treatment (Week 283.9)

Secondary outcome [15]

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set

Assessment method [15]

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Timepoint [15]

Baseline, End of treatment (up to Week 283.9)

Secondary outcome [16]

Assessment method [16]

Timepoint [16]

Baseline, End of treatment (Week 283.9)

Secondary outcome [17]

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set

Assessment method [17]

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

Timepoint [17]

Baseline, End of treatment (up to Week 283.9)

Secondary outcome [18]

Assessment method [18]

Timepoint [18]

Baseline, End of treatment (up to Week 283.9)

Secondary outcome [19]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)

Assessment method [19]

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAEs were those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period TEAEs included both serious TEAEs and non-serious TEAEs. Any AE that was suspicious to be a potential Immune-related adverse event (irAE) including infusion related reactions were considered AESIs. Number of participants with TEAEs and AESIs were reported.

Timepoint [19]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [20]

Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Assessment method [20]

Number of participants with shifts from Baseline values (Grade 0/1/2/3) to abnormal post-baseline values (shift to \>= Grade 4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in laboratory parameter (anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased and Hyperglycemia) were reported.

Timepoint [20]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [21]

Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase

Assessment method [21]

The number of participants with changes from baseline in increased Body Temperature (degree Celsius \[°C\]) were reported by using criteria: Baseline temperature (temp.) less than (\<) 37°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, greater than or equal to (\>=)3°C and missing; Baseline temp. 37 - \<38°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 38 - \<39°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 39-\<40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. \>=40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. missing, on treatment change missing.

Timepoint [21]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [22]

Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease

Assessment method [22]

The number of participants with maximal on-treatment changes from baseline in Increase (Ic.)/Decrease (Dc.) in maximal weight were reported by using criteria: Ic./Dc. From baseline, on treatment (TR) change \<10 percentage (%), \>=10% and missing.

Timepoint [22]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [23]

Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease

Assessment method [23]

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) heart rate (HR) (beats per minute \[bpm\]) were reported by using criteria: Ic./Dc. BS HR \<100/\>=100 bpm, on treatment change =\<20 bpm, \>20 - =\<40 bpm, \>40 bpm and missing; Ic./Dc. BS HR missing, on treatment change missing.

Timepoint [23]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [24]

Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease

Assessment method [24]

The number of participants with maximal on-treatment changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) (millimeter of mercury \[mmHg\]) were reported by using criteria: Ic./Dc. BS SBP \<140 mmHg and \>=140 mmHg, on maximal treatment (TR) change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS SBP missing, on maximal treatment (TR) change missing; Ic./Dc. BS DBP \<90 mmHg and \>= 90 mmHg, on maximal TR change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS DBP missing on maximal TR change missing.

Timepoint [24]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [25]

Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease

Assessment method [25]

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR \<20 breaths per minute (breaths/min), on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing. Ic./Dc. BS RR missing, on TR change missing. Ic./Dc. BS RR \>=20 breaths/min, on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing.

Timepoint [25]

Time from date of randomization up to data cutoff (assessed up to 71.5 months)

Secondary outcome [26]

Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters

Assessment method [26]

ECG parameters included heart rate, PR interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). PCSA criteria for abnormal value of ECG parameters: any heart rate \<= 50 bpm and decrease from baseline \>=20 bpm , any hear rate \>= 120 bpm and increase from baseline \>= 20 bpm; PR interval: \>= 220 milliseconds (ms) and increase from baseline \>= 20 ms; QRS interval \>= 120 ms; QTcF \> 450 ms, \> 480 ms, \> 500 ms, QTcF increase from baseline \> 30 ms and QTcF increase from baseline \> 60 ms; QTcB \> 450 ms, \> 480 ms, \> 500 ms, QTcB increase from baseline \> 30 ms and QTcB increase from baseline \> 60 ms.

Timepoint [26]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [27]

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score

Assessment method [27]

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value (that is \[i.e.\] highest score).

Timepoint [27]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary outcome [28]

Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab

Assessment method [28]

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Timepoint [28]

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Eligibility

Key inclusion criteria

* Male or female subjects aged greater than or equal to (>=) 18 years
* With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
* At least 1 measurable tumor lesion
* With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
* With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
* Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
* Other protocol defined criteria could apply

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
* Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
* Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v 4.03.
* Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
* Other protocol defined criteria could apply

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

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

29/10/2015

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

29/01/2024

Sample size

Target

Accrual to date

Final

1214

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC,WA

Recruitment hospital [1]

Albury Wodonga Regional Cancer Centre - Albury

Recruitment hospital [2]

Coffs Harbour Health Campus - Coffs Harbour

Recruitment hospital [3]

St George Private Hospital - Kogarah

Recruitment hospital [4]

Lismore Base Hospital - Lismore

Recruitment hospital [5]

Orange Health Service - Orange

Recruitment hospital [6]

Royal North Shore Hospital - St Leonards

Recruitment hospital [7]

Calvary Mater Newcastle - Waratah

Recruitment hospital [8]

Gallipoli Medical Research Foundation Ltd - Greenslopes

Recruitment hospital [9]

Gold Coast University Hospital - Southport

Recruitment hospital [10]

The Queen Elizabeth Hospital - Woodville South

Recruitment hospital [11]

Ballarat Base Hospital - Ballarat

Recruitment hospital [12]

Bendigo Hospital - Bendigo

Recruitment hospital [13]

South West Healthcare - Warrnambool

Recruitment hospital [14]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

2640 - Albury

Recruitment postcode(s) [2]

2450 - Coffs Harbour

Recruitment postcode(s) [3]

2217 - Kogarah

Recruitment postcode(s) [4]

2480 - Lismore

Recruitment postcode(s) [5]

2800 - Orange

Recruitment postcode(s) [6]

2065 - St Leonards

Recruitment postcode(s) [7]

2298 - Waratah

Recruitment postcode(s) [8]

4120 - Greenslopes

Recruitment postcode(s) [9]

4215 - Southport

Recruitment postcode(s) [10]

5011 - Woodville South

Recruitment postcode(s) [11]

3350 - Ballarat

Recruitment postcode(s) [12]

3550 - Bendigo

Recruitment postcode(s) [13]

3280 - Warrnambool

Recruitment postcode(s) [14]

6150 - Murdoch

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

Arizona

Country [3]

United States of America

State/province [3]

California

Country [4]

United States of America

State/province [4]

Florida

Country [5]

United States of America

State/province [5]

Georgia

Country [6]

United States of America

State/province [6]

Louisiana

Country [7]

United States of America

State/province [7]

Michigan

Country [8]

United States of America

State/province [8]

Montana

Country [9]

United States of America

State/province [9]

Nevada

Country [10]

United States of America

State/province [10]

New Mexico

Country [11]

United States of America

State/province [11]

North Carolina

Country [12]

United States of America

State/province [12]

Oklahoma

Country [13]

United States of America

State/province [13]

Oregon

Country [14]

United States of America

State/province [14]

Pennsylvania

Country [15]

United States of America

State/province [15]

Tennessee

Country [16]

United States of America

State/province [16]

Texas

Country [17]

United States of America

State/province [17]

Vermont

Country [18]

United States of America

State/province [18]

Washington

Country [19]

United States of America

State/province [19]

Wyoming

Country [20]

Belgium

State/province [20]

Antwerpen

Country [21]

Belgium

State/province [21]

Brasschaat

Country [22]

Belgium

State/province [22]

Mons

Country [23]

Brazil

State/province [23]

Bahia

Country [24]

Brazil

State/province [24]

Ceará

Country [25]

Brazil

State/province [25]

Goiás

Country [26]

Brazil

State/province [26]

Paraná

Country [27]

Brazil

State/province [27]

Rio Grande Do Sul

Country [28]

Brazil

State/province [28]

Santa Catarina

Country [29]

Brazil

State/province [29]

Sao Paulo

Country [30]

Brazil

State/province [30]

Rio de Janeiro

Country [31]

Bulgaria

State/province [31]

Ruse

Country [32]

Bulgaria

State/province [32]

Sofia

Country [33]

Canada

State/province [33]

New Brunswick

Country [34]

Canada

State/province [34]

Ontario

Country [35]

Chile

State/province [35]

Santiago

Country [36]

Chile

State/province [36]

Viña del Mar

Country [37]

China

State/province [37]

Beijing

Country [38]

China

State/province [38]

Guangdong

Country [39]

China

State/province [39]

Heilongjiang

Country [40]

China

State/province [40]

Liaoning

Country [41]

China

State/province [41]

Shandong

Country [42]

Colombia

State/province [42]

Bogotá

Country [43]

Colombia

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Herning

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France

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France

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Sarthe

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Deszk

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Györ

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Tel Aviv

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Italy

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Pisa

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Tokyo-To

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Chungcheongbuk-do

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Gangwon-do

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Korea, Republic of

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Gyeonggi-do

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Korea, Republic of

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Daegu

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Incheon

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Beirut

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Saida

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Kaunas

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Groningen

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Netherlands

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Hoorn

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Tilburg

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Auckland

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Dunedin

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Hamilton

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New Zealand

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Palmerston North

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Tauranga

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Wellington

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Otwock

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Porto

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Portugal

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Santa Maria da Feira

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Portugal

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Baia Mare

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Brasov

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Bucuresti

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Cluj Napoca

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Cluj-Napoca

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Comuna Floresti

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Constanta

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Gornji Matejevac

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Serbia

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Kragujevac

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Serbia

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Bardejov

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Málaga

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Sevilla

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Spain

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Turkey

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Turkey

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Turkey

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Turkey

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Izmir

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Turkey

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Malatya

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Turkey

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Mersin

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Turkey

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Sakarya

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Turkey

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Tekirdag

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Ukraine

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Chernivtsi

Country [216]

Ukraine

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Dnipro

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Ukraine

State/province [217]

Ivano-Frankivsk

Country [218]

Ukraine

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Kharkiv

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Ukraine

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Kherson

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Ukraine

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Kropyvnytskyi

Country [221]

Ukraine

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Kryvyi Rih, Dnipropetrovsk Region

Country [222]

Ukraine

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Kyiv

Country [223]

Ukraine

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Lutsk

Country [224]

Ukraine

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Lviv

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Ukraine

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Odesa

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Ukraine

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Sumy

Country [227]

Ukraine

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Uzhgorod

Country [228]

Ukraine

State/province [228]

Vinnytsia

Country [229]

United Kingdom

State/province [229]

Essex

Country [230]

United Kingdom

State/province [230]

Gloucestershire

Country [231]

United Kingdom

State/province [231]

Greater London

Country [232]

United Kingdom

State/province [232]

Hertfordshire

Country [233]

United Kingdom

State/province [233]

Merseyside

Country [234]

United Kingdom

State/province [234]

Staffordshire

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

EMD Serono Research & Development Institute, Inc.

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Merck KGaA, Darmstadt, Germany

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Trial website

https://clinicaltrials.gov/study/NCT02576574

Trial related presentations / publications

Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Ozguroglu M, Dols MC, Sullivan R, Kowalski DM, Andric Z, Lee DH, Sezer A, Hu P, Wang X, von Heydebreck A, Jacob N, Mehr KT, Park K. Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. J Thorac Oncol. 2024 Feb;19(2):297-313. doi: 10.1016/j.jtho.2023.09.1445. Epub 2023 Sep 24.

Public notes

Contacts

Principal investigator

Name

Medical Responsible

Address

EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol
Statistical analysis plan

Results publications and other study-related documents

Type	Citations or Other Details
Journal	Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Oz... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT02576574

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02576574