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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03739710




Registration number
NCT03739710
Ethics application status
Date submitted
9/11/2018
Date registered
9/11/2018
Date last updated
7/02/2019

Titles & IDs
Public title
Phase II Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC)
Scientific title
A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
Secondary ID [1] 0 0
205801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 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
Treatment: Drugs - Docetaxel
Treatment: Drugs - GSK3359609 (ICOS Agonist)

Experimental: Subjects receiving GSK3359609 (ICOS Agonist) + Docetaxel - Subjects will receive the combination once every 3 weeks as an IV infusion. Subjects receiving docetaxel will be premedicated according to approved product label or standard practice.

Active Comparator: Subjects receiving Docetaxel - Subjects will receive docetaxel once in every 3 weeks as an intravenous infusion.


Treatment: Drugs: Docetaxel
Docetaxel will be administered as an intravenous (IV) infusion at a dose of 75 milligram per meter squared (mg/m^2) once every three weeks.

Treatment: Drugs: GSK3359609 (ICOS Agonist)
GSK3359609 will be administered as an IV infusion at a dose of 80 mg once every 3 weeks.

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

Outcomes
Primary outcome [1] 0 0
Time of overall survival - Overall survival time of subjects from randomization to death will be evaluated.
Timepoint [1] 0 0
Up to 106 Weeks
Secondary outcome [1] 0 0
Survival rate at 12 months - Milestone survival rate of participants treated with experimental regimens versus SoC therapy.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Survival rate at 18 months - Milestone survival rate of participants treated with experimental regimens versus SoC therapy.
Timepoint [2] 0 0
Up to 18 months
Secondary outcome [3] 0 0
Number of participants with Complete response (CR) - Number of participants with CR as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Number of participants with Partial response (PR) - Number of participants with PR as per RECIST version 1.1 criteria.
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Number of participants with Stable disease (SD) - Number of participants with SD as per RECIST version 1.1 criteria.
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Number of participants with Progressive disease (PD) - Number of participants with PD as per RECIST version 1.1 criteria.
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Progression-free survival (PFS) - PFS is defined as time from the date of randomization to the date of disease progression or death whichever occurs earlier.
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Overall response rate (ORR) - ORR is defined as the percentage of participants with a confirmed CR or PR at any time per RECIST version 1.1 criteria.
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Duration of response (DOR) - DOR is defined as the first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria.
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Number of participants with iCR - Number of participants with iCR per modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria.
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Number of participants with iPR - Number of participants with iPR per iRECIST criteria.
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Number of participants with unconfirmed progressive disease (iUPD) - Number of participants with iUPD per iRECIST criteria.
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Number of participants with confirmed progressive disease (iCPD) - Number of participants with iCPD per iRECIST criteria.
Timepoint [13] 0 0
Up to 4 years
Secondary outcome [14] 0 0
Number of participants with iSD - Number of participants with iSD per iRECIST criteria.
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
Progression-free survival (iPFS) - PFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria.
Timepoint [15] 0 0
Up to 4 years
Secondary outcome [16] 0 0
Overall response rate (iORR) - ORR is defined as the percentage of participants with a confirmed CR or PR at any time per iRECIST criteria.
Timepoint [16] 0 0
Up to 4 years
Secondary outcome [17] 0 0
Duration of response (iDOR) - iDOR is defined as the first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.
Timepoint [17] 0 0
Up to 4 years
Secondary outcome [18] 0 0
Number of participants with adverse events (AE) - An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Timepoint [18] 0 0
Up to 2 years
Secondary outcome [19] 0 0
Number of participants with Adverse events of special interest (AESI) - Number of participants with AESI will be recorded for safety assessment. AESI are defined as events of potential immunologic etiology, including Immune-Related Adverse Events (irAEs).
Timepoint [19] 0 0
Up to 2 years
Secondary outcome [20] 0 0
Number of participants with Serious adverse events (SAE) - A SAE is defined as any untoward occurrence that will lead to death or is life-threatening, or requires hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or any congenital anomaly/birth defect.
Timepoint [20] 0 0
Up to 2 years
Secondary outcome [21] 0 0
Number of participants with AEs or SAEs leading to dose modification - Participants who underwent dose modification due to AEs or SAEs will be recorded.
Timepoint [21] 0 0
Up to 2 years
Secondary outcome [22] 0 0
Number of participants with AEs or SAEs leading to dose delays - Participants will have dose delays due to AEs or SAEs will be recorded.
Timepoint [22] 0 0
Up to 2 years
Secondary outcome [23] 0 0
Number of participants with AEs or SAEs leading to withdrawals - Participants who withdrew from the study due to AEs or SAEs will be recorded.
Timepoint [23] 0 0
Up to 2 years
Secondary outcome [24] 0 0
Change from Baseline in temperature - Temperature will be measured after 5 minutes of rest.
Timepoint [24] 0 0
Baseline and up to 106 Weeks
Secondary outcome [25] 0 0
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) - Blood pressure both systolic and diastolic will be measured after 5 minutes of rest.
Timepoint [25] 0 0
Baseline and up to 106 Weeks
Secondary outcome [26] 0 0
Change from Baseline in pulse rate - Pulse rate will be measured after 5 minutes of rest.
Timepoint [26] 0 0
Baseline and up to 106 Weeks
Secondary outcome [27] 0 0
Change from Baseline in respiratory rate - Respiratory rate will be measured after 5 minutes of rest.
Timepoint [27] 0 0
Baseline and up to 106 Weeks
Secondary outcome [28] 0 0
Change from Baseline in oxygen saturation - Oxygen saturation will be measured after 5 minutes of rest.
Timepoint [28] 0 0
Baseline and up to 106 Weeks
Secondary outcome [29] 0 0
Change from Baseline of hematology parameters: eosinophils, lymphocytes, monocytes, basophils, neutrophils, platelet and leukocytes - Change from Baseline for parameters such as eosinophils, lymphocytes, monocytes, basophils, neutrophils, platelet and leukocytes will be evaluated.
Timepoint [29] 0 0
Baseline and up to 106 Weeks
Secondary outcome [30] 0 0
Change from Baseline of hematology parameters: hematocrit - Change from Baseline for parameter such as hematocrit will be evaluated.
Timepoint [30] 0 0
Baseline and up to 106 Weeks
Secondary outcome [31] 0 0
Change from Baseline of hematology parameter: hemoglobin - Change from Baseline for parameter such as hemoglobin will be evaluated.
Timepoint [31] 0 0
Baseline and up to 106 Weeks
Secondary outcome [32] 0 0
Change from Baseline of hematology parameter: mean corpuscular hemoglobin - Change from Baseline for parameter such as mean corpuscular hemoglobin will be evaluated.
Timepoint [32] 0 0
Baseline and up to 106 Weeks
Secondary outcome [33] 0 0
Change from Baseline of hematology parameter: mean corpuscular volume - Change from Baseline for parameter such as mean corpuscular volume will be evaluated.
Timepoint [33] 0 0
Baseline and up to 106 Weeks
Secondary outcome [34] 0 0
Change from Baseline in hematology parameter: Red blood cell (RBC) count - Change from Baseline for parameter such as RBC count will be evaluated.
Timepoint [34] 0 0
Baseline and up to 106 Weeks
Secondary outcome [35] 0 0
Change from Baseline of Clinical chemistry parameters: glucose, sodium, Blood Urea Nitrogen (BUN), calcium, and potassium - Change from Baseline for parameters such as glucose, sodium, BUN, calcium, and potassium will be evaluated.
Timepoint [35] 0 0
Baseline and up to 106 Weeks
Secondary outcome [36] 0 0
Change from Baseline of Clinical chemistry parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) - Change from Baseline for parameters such as alkaline phosphatase, ALT, and AST will be evaluated.
Timepoint [36] 0 0
Baseline and up to 106 Weeks
Secondary outcome [37] 0 0
Change from Baseline of Clinical chemistry parameters: Direct bilirubin, Bilirubin, Creatinine. - Change from Baseline for parameters such as direct bilirubin, bilirubin, and creatinine will be evaluated.
Timepoint [37] 0 0
Baseline and up to 106 Weeks
Secondary outcome [38] 0 0
Change from Baseline of Clinical chemistry parameters: lactate dehydrogenase (LDH) - Change from Baseline for parameter such as LDH will be evaluated.
Timepoint [38] 0 0
Baseline and up to 106 Weeks
Secondary outcome [39] 0 0
Change from Baseline of Clinical chemistry parameters: Total protein and albumin - Change from Baseline for parameters such as total protein and albumin will be evaluated.
Timepoint [39] 0 0
Baseline and up to 106 Weeks
Secondary outcome [40] 0 0
Change from Baseline in urinalysis parameters: ketones - Change from Baseline for parameter such as ketones will be evaluated.
Timepoint [40] 0 0
Baseline and up to 106 Weeks
Secondary outcome [41] 0 0
Change from Baseline in Urinalysis parameter: Specific gravity - Change from Baseline for parameter such as specific gravity will be evaluated.
Timepoint [41] 0 0
Baseline and up to 106 Weeks
Secondary outcome [42] 0 0
Change from Baseline in Urinalysis parameter: pH - Change from Baseline for parameter such as pH will be evaluated.
Timepoint [42] 0 0
Baseline and up to 106 Weeks
Secondary outcome [43] 0 0
Change from Baseline in Urinalysis parameter: glucose - Change from Baseline for parameter such as glucose will be evaluated.
Timepoint [43] 0 0
Baseline and up to 106 Weeks
Secondary outcome [44] 0 0
Change from Baseline in Urinalysis parameter: protein - Change from Baseline for parameter such as protein will be evaluated.
Timepoint [44] 0 0
Baseline and up to 106 Weeks
Secondary outcome [45] 0 0
Change from Baseline in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score - Performance status will be assessed using the ECOG scale, with Grades ranging from 0 to 5.
Timepoint [45] 0 0
Baseline and up to 106 Weeks
Secondary outcome [46] 0 0
Serum levels of antidrug-antibodies (ADA) to GSK3359609 ICOS agonist. - Serum samples will be collected and tested for the presence of antibodies that bind to GSK3359609 (ICOS agonist).
Timepoint [46] 0 0
Predose on Weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61, 73, 85 and 97
Secondary outcome [47] 0 0
Maximum observed concentration (Cmax) for GSK3359609 (ICOS agonist) - Blood samples will be collected at indicated time points to calculate Cmax for GSK3359609 (ICOS agonist).
Timepoint [47] 0 0
Predose on Weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61, 73, 85 and 97; end of infusion (within 5 minutes) and 4 hours post end of infusion on Week 1; end of infusion (within 5 minutes) at Weeks 13 and 25.
Secondary outcome [48] 0 0
Cmax for SoC (docetaxel) - Blood samples will be collected at indicated time points to calculate Cmax for Soc (docetaxel).
Timepoint [48] 0 0
Predose on Day 1; end of SoC infusions (within 5 minutes) at Weeks 1, 4, 7, 10, 13, 16, 19 and 22; Between 2 and 5 hours after SoC infusion at Weeks 1, 4, 7, 10, 13, 16, 19 and 22
Secondary outcome [49] 0 0
Minimum observed concentration (Cmin) for GSK3359609 (ICOS agonist) - Blood samples will be collected at indicated time points to calculate Cmin for GSK3359609 (ICOS agonist).
Timepoint [49] 0 0
Predose on Weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61, 73, 85 and 97; end of infusion (within 5 minutes) and 4 hours post end of infusion on Week 1; end of infusion (within 5 minutes) at Weeks 13 and 25.
Secondary outcome [50] 0 0
Cmin for SoC (docetaxel) - Blood samples will be collected at indicated time points to calculate Cmin for Soc (docetaxel).
Timepoint [50] 0 0
Predose on Day 1; end of SoC infusions (within 5 minutes) at Weeks 1, 4, 7, 10, 13, 16, 19 and 22; Between 2 and 5 hours after SoC infusion at Weeks 1, 4, 7, 10, 13, 16, 19 and 22

Eligibility
Key inclusion criteria
- Subjects capable of giving signed informed consent/assent.

- Male or female, aged 18 years or older at the time consent is obtained.

- Subjects with histologically or cytologically confirmed diagnosis of NSCLC (squamous
or non-squamous) and: a. Documented disease progression (for example, based on
radiographic imaging) during or after a maximum of 2 lines of systemic treatment for
locally/regionally advanced recurrent, Stage IIIb/Stage IV or metastatic disease: i. A
maximum of 1 line of platinum-containing chemotherapy regimen in the metastatic
setting, and ii. A maximum of 1 line of PD(L)1 monoclonal antibody (mAb) containing
regimen. b. Participants with known BRAF molecular alterations must have had disease
progression after receiving the locally available SoC treatment for the molecular
alteration. Participants with this alteration could have received up to 3 lines of
systemic anticancer therapy.

- Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.

- ECOG PS score of 0 or 1.

- A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time
of study entry is mandatory. Although a fresh tumor tissue sample obtained during
screening is preferred, archival tumor specimen is acceptable.

- Adequate organ function.

- A male subject must agree to use a highly effective contraception during the treatment
period and for at least 120 days after the last dose of study treatment and refrain
from donating sperm during this period.

- A female subject is eligible to participate if she is not pregnant, not breastfeeding,
and at least 1 of the following conditions apply: a) Not a woman of childbearing
potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during
the treatment period and for at least 120 days after the last dose of study treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who received prior treatment with the following therapies (calculation is
based on date of last therapy to date of first dose of study treatment): a. Docetaxel
at any time. b. Any of the investigational agents being tested in the current study,
including experimental ICOS agonist. c. Systemic approved or investigational
anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter.
At least 14 days must have elapsed between the last dose of prior anticancer agent and
the first dose of study drug is administered. d. Prior radiation therapy: permissible
if at least one non-irradiated measurable lesion is available for assessment per
RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective
progression is documented. A wash out of at least 2 weeks before start of study drug
for radiation of any intended use is required.

- Received >=3 prior lines of therapy for NSCLC, including subjects with BRAF molecular
alternations.

- Invasive malignancy or history of invasive malignancy other than disease under study
within the last 2 years.

- Central nervous system (CNS) metastases, with the following exception: Subjects with
asymptomatic CNS metastases who are clinically stable and have no requirement for
steroids for at least 14 days prior to first dose of study treatment.

- Major surgery <= 28 days of first dose of study treatment.

- Autoimmune disease (current or history) or syndrome that required systemic treatment
within the past 2 years. Replacement therapies which include physiological doses of
corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency)
are not considered systemic treatments.

- Receiving systemic steroids (>=10 milligram [mg] oral prednisone or equivalent) or
other immunosuppressive agents within 7 days prior to first dose of study treatment.

- Prior allogeneic/autologous bone marrow or solid organ transplantation.

- Receipt of any live vaccine within 30 days prior to first dose of study treatment.

- Toxicity from previous anticancer treatment that includes: a. >= Grade 3 toxicity
considered related to prior immunotherapy and that led to treatment discontinuation.
b. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except
alopecia, hearing loss, endocrinopathy managed with replacement therapy, and
peripheral neuropathy which must be <= Grade 2).

- History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for
past-pneumonitis exclusion only if steroids were required for treatment), interstitial
lung disease, or organizing pneumonia.

- Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural
or pericardial effusions.

- Recent history (within the past 6 months) of gastrointestinal obstruction that
required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal
abscess.

- History or evidence of cardiac abnormalities within the 6 months prior to enrollment.

- Current unstable liver or biliary disease per investigator assessment defined by the
presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or
gastric varices, persistent jaundice, or cirrhosis.

- Active infection requiring systemic therapy.

- Subjects with known human immunodeficiency virus infection, or positive test for
hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C
active infection.

- Subjects with history of severe hypersensitivity to monoclonal antibodies or
hypersensitivity to ingredients used in the formulation of docetaxel.

- Subjects requiring ongoing therapy with a medication that is a strong inhibitor or
inducer of the cytochrome 3A4 (CYP3A4) enzymes.

- Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric
disorder, or other condition that could interfere with participant's safety, obtaining
informed consent, or compliance to the study procedures in the opinion of the
investigator.

- Pregnant or lactating female subjects.

- Subject is currently participating in or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks prior to
the first dose of study treatment.

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 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Gosford
Recruitment hospital [3] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [4] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [5] 0 0
GSK Investigational Site - Ballarat
Recruitment hospital [6] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [7] 0 0
GSK Investigational Site - Frankston
Recruitment hospital [8] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [9] 0 0
GSK Investigational Site - Shepparton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3630 - Shepparton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
District of Columbia
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
Illinois
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
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
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Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
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Tennessee
Country [18] 0 0
United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
Country [21] 0 0
United States of America
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Washington
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United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
New Brunswick
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Denmark
State/province [27] 0 0
Hillerød
Country [28] 0 0
Denmark
State/province [28] 0 0
Købenavn Ø
Country [29] 0 0
Denmark
State/province [29] 0 0
Næstved
Country [30] 0 0
France
State/province [30] 0 0
Bordeaux Cedex
Country [31] 0 0
France
State/province [31] 0 0
Bron cedex
Country [32] 0 0
France
State/province [32] 0 0
Caen Cedex 9
Country [33] 0 0
France
State/province [33] 0 0
Grenoble cedex 9
Country [34] 0 0
France
State/province [34] 0 0
Lille
Country [35] 0 0
France
State/province [35] 0 0
Nantes cedex 1
Country [36] 0 0
France
State/province [36] 0 0
Paris Cedex 05
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
Villejuif Cedex
Country [39] 0 0
Germany
State/province [39] 0 0
Baden-Wuerttemberg
Country [40] 0 0
Germany
State/province [40] 0 0
Bayern
Country [41] 0 0
Germany
State/province [41] 0 0
Hessen
Country [42] 0 0
Germany
State/province [42] 0 0
Sachsen-Anhalt
Country [43] 0 0
Germany
State/province [43] 0 0
Sachsen
Country [44] 0 0
Germany
State/province [44] 0 0
Schleswig-Holstein
Country [45] 0 0
Germany
State/province [45] 0 0
Berlin
Country [46] 0 0
Italy
State/province [46] 0 0
Campania
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Italy
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Emilia-Romagna
Country [48] 0 0
Italy
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Lazio
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Italy
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Lombardia
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Italy
State/province [50] 0 0
Piemonte
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Italy
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Toscana
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Cheongju-si, Chungcheongbuk-do
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Korea, Republic of
State/province [53] 0 0
Gyeonggi-do
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seongnam
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Korea, Republic of
State/province [55] 0 0
Seoul
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Netherlands
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Amsterdam
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Netherlands
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Maastricht
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Netherlands
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Rotterdam
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Poland
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Biala Podlaska
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Konin
Country [63] 0 0
Poland
State/province [63] 0 0
Otwock
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Poland
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Poznan
Country [65] 0 0
Poland
State/province [65] 0 0
Warszawa
Country [66] 0 0
Poland
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Zakopane
Country [67] 0 0
Romania
State/province [67] 0 0
Bucharest
Country [68] 0 0
Romania
State/province [68] 0 0
Bucuresti
Country [69] 0 0
Romania
State/province [69] 0 0
Cluj Napoca
Country [70] 0 0
Romania
State/province [70] 0 0
Cluj-Napoca
Country [71] 0 0
Romania
State/province [71] 0 0
Craiova
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Romania
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Floresti
Country [73] 0 0
Romania
State/province [73] 0 0
Otopeni
Country [74] 0 0
Romania
State/province [74] 0 0
Timisoara
Country [75] 0 0
Russian Federation
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Chelyabinsk
Country [76] 0 0
Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Badajoz
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Spain
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Barcelona
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Spain
State/province [80] 0 0
Madrid
Country [81] 0 0
Spain
State/province [81] 0 0
Málaga
Country [82] 0 0
Spain
State/province [82] 0 0
Santander
Country [83] 0 0
Spain
State/province [83] 0 0
Sevilla
Country [84] 0 0
Sweden
State/province [84] 0 0
Lund
Country [85] 0 0
Sweden
State/province [85] 0 0
Solna

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the clinical activity of novel immune-oncology agents (in combination
or as single agents) to standard of care in participants with relapsed/refractory advanced
NSCLC. The study will initially evaluate two treatment regimens/arms. Additional
regimens/arms may be added via future protocol amendment(s). Participants will be stratified
by histology (squamous vs. non-squamous) and line of anti-programmed cell death ligand 1
(PD[L]1) therapy (first vs. second line). Initially, the study will evaluate the GSK3359609
inducible T-cell co-stimulator (ICOS) agonist in combination with SoC docetaxel compared to
docetaxel alone (sub-study 1). SoC arm will be the common comparison arm across all
sub-studies. At study start, subjects will be randomized to the study at a ratio of 1:2 to
Arm 1 (docetaxel) and Arm 2 (ICOS agonist + docetaxel). The study will consist of three
periods: Screening, Treatment, and Follow-Up. There will be approximately 105 participants
enrolled in the study initially. Treatment will continue for approximately 2 years and
participants will be followed for survival during the follow-up period.
Trial website
https://clinicaltrials.gov/show/NCT03739710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03739710