Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1
Study Details
Study Description
Brief Summary
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Docetaxel
|
Drug: Docetaxel
Docetaxel was administered as IV infusion.
|
| Experimental: Feladilimab plus Docetaxel
|
Drug: Docetaxel
Docetaxel was administered as IV infusion.
Drug: Feladilimab
Feladilimab was administered as IV infusion.
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Up to 2 years]
Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method.
Secondary Outcome Measures
- Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months [Month 12 and 18]
Overall survival was defined as the time between date of randomization and death due to any cause. Kaplan-Meier estimates of the percentage of participants who died at each time point was calculated. Confidence Intervals estimated using the Brookmeyer Crowley method.
- Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable [Up to 2 years]
CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
- Kaplan-Meier Estimates of Progression-Free Survival (PFS) [Up to 2 years]
PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method.
- Objective Response Rate [Up to 2 years]
ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
- Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response [Up to 2 years]
DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method.
- Disease Control Rate (DCR) [Up to 2 years]
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
- Number of Participants With iRECIST Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), Stable Disease (iSD) or Not Evaluable [Up to 2 years]
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
- Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS) [Up to 2 years]
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method.
- iRECIST Objective Response Rate (iORR) [Up to 2 years]
iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
- Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response [Up to 2 years]
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method.
- Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals [Up to 2 years]
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology.
- Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline [Up to 2 years]
Blood samples were collected for assessment of the clinical chemistry parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with clinical chemistry results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented.
- Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline [Up to 2 years]
Blood samples were collected for assessment of the hematology parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with Hematology results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented.
- Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline [Up to 2 years]
Blood Pressure was measured after 5 minutes of rest and was taken in the same position throughout the study. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE. Number of participants with vital signs results by maximum grade increase (Increase to Grade 2 or Increase to Grade 3) are presented.
- Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline [Up to 2 years]
Body temperature was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <=35 Degrees Celsius, Change to Normal or No Change and Increase to >=38 Degrees Celsius.
- Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline [Up to 2 years]
Pulse Rate was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <50 beats per minute, Change to Normal or No Change and Increase to >120 beats per minute.
- Minimum Observed Concentration (CmIn) of Feladilimab [Week 1]
Blood samples were collected for assessment of the pharmacokinetic parameters.
- Maximum Observed Concentration (Cmax) of Feladilimab [Week 1, Week 13 and Week 25]
Blood samples were collected for assessment of the pharmacokinetic parameters.
- Maximum Observed Concentration (Cmax) of Docetaxel [Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22]
Blood samples were collected for assessment of the pharmacokinetic parameters.
- Number of Participants With Positive Anti-drug Antibodies (ADA) Against Docetaxel [Up to 2 years]
- Number of Participants With Positive ADA Against Feladilimab [Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants capable of giving signed informed consent/assent.
-
Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
-
Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
-
Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen.
-
Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
-
Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
-
Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (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 as defined in the protocol.
-
A male participant 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 participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP) or ii) 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.
- Life expectancy of at least 12 weeks.
Exclusion Criteria:
- Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
-
Docetaxel at any time.
-
Any of the investigational agents being tested in the current study.
-
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.
-
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 greater than (>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
-
Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except
-
Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
-
Curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma.
-
Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
-
Major surgery less than or equal to (<=) 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 milligrams [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:
-
Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation.
-
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 which include
-
Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block.
-
Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.
-
Symptomatic pericarditis.
-
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 <=7 days prior to first dose of study treatment.
-
Participants with known human immunodeficiency virus infection.
-
Participants with history of severe hypersensitivity to mAb or hypersensitivity to any of the study treatment(s) or their excipients.
-
Participants requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P 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 participants.
-
Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
-
Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
-
Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
-
Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
-
Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Saint Louis | Missouri | United States | 63110-1093 |
| 2 | GSK Investigational Site | Nashville | Tennessee | United States | 37203 |
| 3 | GSK Investigational Site | Dallas | Texas | United States | 75230 |
| 4 | GSK Investigational Site | Toronto | Ontario | Canada | M5G 2M9 |
| 5 | GSK Investigational Site | Bordeaux Cedex | France | 33076 | |
| 6 | GSK Investigational Site | Caen Cedex 9 | France | 14033 | |
| 7 | GSK Investigational Site | Nantes cedex 1 | France | 44093 | |
| 8 | GSK Investigational Site | Paris Cedex 05 | France | 75248 | |
| 9 | GSK Investigational Site | Paris | France | 75018 | |
| 10 | GSK Investigational Site | Villejuif Cedex | France | 94805 | |
| 11 | GSK Investigational Site | Gauting | Bayern | Germany | |
| 12 | GSK Investigational Site | Immenhausen | Hessen | Germany | 34376 |
| 13 | GSK Investigational Site | Leipzig | Sachsen | Germany | |
| 14 | GSK Investigational Site | Grosshansdorf | Schleswig-Holstein | Germany | 22927 |
| 15 | GSK Investigational Site | Berlin | Germany | 14165 | |
| 16 | GSK Investigational Site | Meldola (FC) | Emilia-Romagna | Italy | 47014 |
| 17 | GSK Investigational Site | Ravenna | Emilia-Romagna | Italy | 48121 |
| 18 | GSK Investigational Site | Milano | Lombardia | Italy | 20133 |
| 19 | GSK Investigational Site | Orbassano (TO) | Piemonte | Italy | 10043 |
| 20 | GSK Investigational Site | Cheongju-si | Korea, Republic of | 28644 | |
| 21 | GSK Investigational Site | Gyeonggi-do | Korea, Republic of | 10408 | |
| 22 | GSK Investigational Site | Seongnam | Korea, Republic of | 13620 | |
| 23 | GSK Investigational Site | Seoul | Korea, Republic of | 05505 | |
| 24 | GSK Investigational Site | Maastricht | Netherlands | 6229 HX | |
| 25 | GSK Investigational Site | Lodz | Poland | 93-513 | |
| 26 | GSK Investigational Site | Poznan | Poland | 60-569 | |
| 27 | GSK Investigational Site | Warszawa | Poland | 02-781 | |
| 28 | GSK Investigational Site | Bucharest | Romania | 020142 | |
| 29 | GSK Investigational Site | Craiova | Romania | 200347 | |
| 30 | GSK Investigational Site | Floresti | Romania | 407280 | |
| 31 | GSK Investigational Site | Otopeni | Romania | 075100 | |
| 32 | GSK Investigational Site | Timisoara | Romania | 300166 | |
| 33 | GSK Investigational Site | Chelyabinsk | Russian Federation | 454048 | |
| 34 | GSK Investigational Site | Saint-Petersburg | Russian Federation | 194291 | |
| 35 | GSK Investigational Site | Saint-Petersburg | Russian Federation | 197183 | |
| 36 | GSK Investigational Site | Barcelona | Spain | 08035 | |
| 37 | GSK Investigational Site | Barcelona | Spain | 08036 | |
| 38 | GSK Investigational Site | Madrid | Spain | 28027 | |
| 39 | GSK Investigational Site | Madrid | Spain | 28033 | |
| 40 | GSK Investigational Site | Madrid | Spain | ||
| 41 | GSK Investigational Site | Santander | Spain | 39008 | |
| 42 | GSK Investigational Site | Sevilla | Spain | 41009 | |
| 43 | GSK Investigational Site | Uppsala | Sweden | SE- 75 185 |
Sponsors and Collaborators
- GlaxoSmithKline
- iTeos Belgium SA
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
None provided.- 205801-001
- 2018-001316-29
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). | Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Period Title: Overall Study | ||
| STARTED | 35 | 70 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 35 | 70 |
Baseline Characteristics
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | Total |
|---|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). | Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. | Total of all reporting groups |
| Overall Participants | 35 | 70 | 105 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.6
(10.48)
|
64.4
(9.11)
|
63.8
(9.57)
|
| Age, Customized (Count of Participants) | |||
| 18-64 |
22
62.9%
|
31
44.3%
|
53
50.5%
|
| 65-74 |
7
20%
|
28
40%
|
35
33.3%
|
| 75-84 |
5
14.3%
|
11
15.7%
|
16
15.2%
|
| >=85 |
1
2.9%
|
0
0%
|
1
1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
22.9%
|
17
24.3%
|
25
23.8%
|
| Male |
27
77.1%
|
53
75.7%
|
80
76.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
2
2.9%
|
2
1.9%
|
| Not Hispanic or Latino |
35
100%
|
67
95.7%
|
102
97.1%
|
| Unknown or Not Reported |
0
0%
|
1
1.4%
|
1
1%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
3
8.6%
|
0
0%
|
3
2.9%
|
| South Korea |
4
11.4%
|
5
7.1%
|
9
8.6%
|
| Netherlands |
0
0%
|
3
4.3%
|
3
2.9%
|
| Sweden |
0
0%
|
2
2.9%
|
2
1.9%
|
| Romania |
2
5.7%
|
9
12.9%
|
11
10.5%
|
| United States |
5
14.3%
|
7
10%
|
12
11.4%
|
| Poland |
1
2.9%
|
3
4.3%
|
4
3.8%
|
| Italy |
4
11.4%
|
7
10%
|
11
10.5%
|
| France |
6
17.1%
|
9
12.9%
|
15
14.3%
|
| Germany |
3
8.6%
|
7
10%
|
10
9.5%
|
| Spain |
4
11.4%
|
13
18.6%
|
17
16.2%
|
| Russia |
3
8.6%
|
5
7.1%
|
8
7.6%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent To Treat population (ITT) included all participants who were randomized to treatment regardless of whether the participants actually received study treatment. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| Median (95% Confidence Interval) [Months] |
8.2
|
7.8
|
| Title | Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months |
|---|---|
| Description | Overall survival was defined as the time between date of randomization and death due to any cause. Kaplan-Meier estimates of the percentage of participants who died at each time point was calculated. Confidence Intervals estimated using the Brookmeyer Crowley method. |
| Time Frame | Month 12 and 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-To-Treat Population. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| Month 12 |
44
125.7%
|
28
40%
|
| Month 18 |
28
80%
|
18
25.7%
|
| Title | Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable |
|---|---|
| Description | CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-To-Treat Population. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| Complete Response |
0
0%
|
0
0%
|
| Partial Response |
4
11.4%
|
13
18.6%
|
| Stable Disease |
10
28.6%
|
22
31.4%
|
| Progressive Disease |
14
40%
|
23
32.9%
|
| Not Evaluable |
7
20%
|
12
17.1%
|
| Title | Kaplan-Meier Estimates of Progression-Free Survival (PFS) |
|---|---|
| Description | PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat Population. Only those participants with data available at specified data points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). | Participants with NSLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion once Q3W. |
| Measure Participants | 29 | 62 |
| Median (95% Confidence Interval) [Months] |
3.3
|
3.4
|
| Title | Objective Response Rate |
|---|---|
| Description | ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-To-Treat Population |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| Number (95% Confidence Interval) [Percentage of Participants] |
11
31.4%
|
19
27.1%
|
| Title | Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response |
|---|---|
| Description | DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent To Treat Population. Only participants who achieved Objective Response were evaluated. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 4 | 13 |
| Median (95% Confidence Interval) [Months] |
4.8
|
4.3
|
| Title | Disease Control Rate (DCR) |
|---|---|
| Description | DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| Number (95% Confidence Interval) [Percentage of Participants] |
40
114.3%
|
50
71.4%
|
| Title | Number of Participants With iRECIST Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), Stable Disease (iSD) or Not Evaluable |
|---|---|
| Description | Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-To-Treat Population. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| iCR |
0
0%
|
0
0%
|
| iPR |
4
11.4%
|
13
18.6%
|
| iUPD |
11
31.4%
|
15
21.4%
|
| iCPD |
3
8.6%
|
8
11.4%
|
| iSD |
10
28.6%
|
22
31.4%
|
| Not Evaluable |
7
20%
|
12
17.1%
|
| Title | Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS) |
|---|---|
| Description | iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat population. Only those participants with data available at specified data points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 29 | 62 |
| Median (95% Confidence Interval) [Months] |
3.3
|
3.4
|
| Title | iRECIST Objective Response Rate (iORR) |
|---|---|
| Description | iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat population. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 35 | 70 |
| Number (95% Confidence Interval) [Percentage of Participants] |
11
31.4%
|
19
27.1%
|
| Title | Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response |
|---|---|
| Description | iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-To-Treat Population. Only the participants with Objective Response were evaluated. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 4 | 13 |
| Median (95% Confidence Interval) [Months] |
4.8
|
4.3
|
| Title | Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals |
|---|---|
| Description | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all the randomized participants who received at least one dose of Standard of Care (SoC), or experimental regimen based on actual treatment received. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 34 | 70 |
| AEs |
34
97.1%
|
70
100%
|
| AESI |
1
2.9%
|
4
5.7%
|
| SAEs |
16
45.7%
|
34
48.6%
|
| AEs leading to permanent discontinuation of study treatment |
12
34.3%
|
16
22.9%
|
| AEs leading to dose reduction |
7
20%
|
13
18.6%
|
| AEs leading to dose interruption/delay |
11
31.4%
|
24
34.3%
|
| Title | Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline |
|---|---|
| Description | Blood samples were collected for assessment of the clinical chemistry parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with clinical chemistry results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at specified data points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 34 | 63 |
| Blood bilirubin increased |
0
0%
|
1
1.4%
|
| Hypercalcemia |
0
0%
|
2
2.9%
|
| Creatinine increased |
0
0%
|
1
1.4%
|
| Title | Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline |
|---|---|
| Description | Blood samples were collected for assessment of the hematology parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with Hematology results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at specified data points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 34 | 64 |
| Anemia |
2
5.7%
|
5
7.1%
|
| Leukocytosis |
0
0%
|
1
1.4%
|
| White blood cell decreased |
5
14.3%
|
11
15.7%
|
| Lymphocyte count decreased |
4
11.4%
|
12
17.1%
|
| Neutrophil count decreased |
4
11.4%
|
13
18.6%
|
| Platelet count decreased |
0
0%
|
3
4.3%
|
| Title | Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline |
|---|---|
| Description | Blood Pressure was measured after 5 minutes of rest and was taken in the same position throughout the study. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE. Number of participants with vital signs results by maximum grade increase (Increase to Grade 2 or Increase to Grade 3) are presented. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at specified time points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion once Q3W. |
| Measure Participants | 34 | 63 |
| Diastolic Blood Pressure |
12
34.3%
|
26
37.1%
|
| Systolic Blood Pressure |
16
45.7%
|
28
40%
|
| Title | Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline |
|---|---|
| Description | Body temperature was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <=35 Degrees Celsius, Change to Normal or No Change and Increase to >=38 Degrees Celsius. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at specified data points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 34 | 63 |
| Decrease to <=35 Degrees Celsius |
0
0%
|
6
8.6%
|
| Change to Normal or No Change |
33
94.3%
|
52
74.3%
|
| Increase to >=38 Degrees Celsius |
1
2.9%
|
5
7.1%
|
| Title | Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline |
|---|---|
| Description | Pulse Rate was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <50 beats per minute, Change to Normal or No Change and Increase to >120 beats per minute. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at specified data points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSLC were administered with Docetaxel 75 milligram per metersquare (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks(Q3W). | Participants with NSLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion once Q3W. |
| Measure Participants | 34 | 63 |
| Decrease to <50 beats per minute |
0
0%
|
0
0%
|
| Change to Normal or No Change |
32
91.4%
|
55
78.6%
|
| Increase to >120 beats per minute |
2
5.7%
|
8
11.4%
|
| Title | Minimum Observed Concentration (CmIn) of Feladilimab |
|---|---|
| Description | Blood samples were collected for assessment of the pharmacokinetic parameters. |
| Time Frame | Week 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) population will consist of all participants from the ITT Population from whom a blood sample was obtained and analyzed for PK concentration. |
| Arm/Group Title | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|
| Arm/Group Description | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 67 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram per millimeter (ng/mL)] |
6104.6
(91.3)
|
| Title | Maximum Observed Concentration (Cmax) of Feladilimab |
|---|---|
| Description | Blood samples were collected for assessment of the pharmacokinetic parameters. |
| Time Frame | Week 1, Week 13 and Week 25 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. |
| Arm/Group Title | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|
| Arm/Group Description | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 67 |
| Week 1 |
24923.7
(26.7)
|
| Week 13 |
28715.9
(45.4)
|
| Week 25 |
32688.4
(27.4)
|
| Title | Maximum Observed Concentration (Cmax) of Docetaxel |
|---|---|
| Description | Blood samples were collected for assessment of the pharmacokinetic parameters. |
| Time Frame | Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 30 | 55 |
| Week 1 |
1500.9
(133.5)
|
1429.9
(138.7)
|
| Week 4 |
1587.1
(128.6)
|
1399.7
(99.3)
|
| Week 7 |
846.8
(166.4)
|
1036.9
(171.2)
|
| Week 10 |
1262.9
(155.4)
|
1248.4
(118.3)
|
| Week 13 |
1354.2
(212.1)
|
1363.4
(137.8)
|
| Week 16 |
1095.3
(114.3)
|
1381.9
(114.0)
|
| Week 19 |
759.0
(74.0)
|
1765.7
(95.1)
|
| Week 22 |
535.5
(10.9)
|
2430.7
(73.3)
|
| Title | Number of Participants With Positive Anti-drug Antibodies (ADA) Against Docetaxel |
|---|---|
| Description | |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected. |
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|---|
| Arm/Group Description | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion Q3W. | Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| Measure Participants | 0 | 0 |
| Title | Number of Participants With Positive ADA Against Feladilimab |
|---|---|
| Description | |
| Time Frame | Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population. Only those participants with data available at specified time points have been analyzed. |
| Arm/Group Title | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
|---|---|
| Arm/Group Description | Participants with NSCLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion once Q3W. |
| Measure Participants | 69 |
| Week 1 |
1
2.9%
|
| Week 4 |
8
22.9%
|
| Week 7 |
4
11.4%
|
| Week 10 |
2
5.7%
|
| Week 13 |
2
5.7%
|
| Week 16 |
1
2.9%
|
| Week 19 |
2
5.7%
|
| Week 22 |
0
0%
|
| Week 25 |
0
0%
|
| Week 37 |
0
0%
|
| Week 49 |
0
0%
|
| Week 61 |
0
0%
|
| Week 73 |
0
0%
|
Adverse Events
| Time Frame | All cause mortality, non-SAEs and SAEs were collected up to 2 years. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all randomized participants who received at least one dose of SoC or experimental regimen based on actual treatment received. | |||
| Arm/Group Title | Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | ||
| Arm/Group Description | Participants with NSLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). | Participants with NSLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. | ||
All Cause Mortality |
||||
| Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/34 (73.5%) | 62/70 (88.6%) | ||
Serious Adverse Events |
||||
| Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/34 (47.1%) | 34/70 (48.6%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 3/34 (8.8%) | 3 | 4/70 (5.7%) | 4 |
| Anaemia | 1/34 (2.9%) | 1 | 2/70 (2.9%) | 2 |
| Neutropenia | 0/34 (0%) | 0 | 2/70 (2.9%) | 2 |
| Leukopenia | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Pancytopenia | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Cardiac disorders | ||||
| Acute coronary syndrome | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Cardiac arrest | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Cardiac failure | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Cardiopulmonary failure | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Right ventricular failure | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/34 (0%) | 0 | 2/70 (2.9%) | 2 |
| Stomatitis | 0/34 (0%) | 0 | 2/70 (2.9%) | 2 |
| Gastric ulcer perforation | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Pancreatitis acute | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| General disorders | ||||
| Asthenia | 0/34 (0%) | 0 | 2/70 (2.9%) | 2 |
| Chest pain | 0/34 (0%) | 0 | 1/70 (1.4%) | 3 |
| Fatigue | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Oedema peripheral | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Pain | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Performance status decreased | 0/34 (0%) | 0 | 1/70 (1.4%) | 2 |
| Sudden death | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Infections and infestations | ||||
| Pneumonia | 6/34 (17.6%) | 7 | 7/70 (10%) | 7 |
| COVID-19 | 0/34 (0%) | 0 | 2/70 (2.9%) | 2 |
| Bronchitis | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Diarrhoea infectious | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Lung abscess | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Pneumocystis jirovecii pneumonia | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Pneumonia mycoplasmal | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Pyelonephritis | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Upper respiratory tract infection | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Spinal compression fracture | 1/34 (2.9%) | 1 | 1/70 (1.4%) | 1 |
| Femur fracture | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Road traffic accident | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Investigations | ||||
| Troponin increased | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Bone pain | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebrovascular accident | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Seizure | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Renal failure | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Reproductive system and breast disorders | ||||
| Pelvic pain | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumonitis | 1/34 (2.9%) | 1 | 2/70 (2.9%) | 2 |
| Pulmonary embolism | 0/34 (0%) | 0 | 3/70 (4.3%) | 3 |
| Chronic obstructive pulmonary disease | 1/34 (2.9%) | 1 | 1/70 (1.4%) | 1 |
| Haemoptysis | 0/34 (0%) | 0 | 2/70 (2.9%) | 2 |
| Acute respiratory distress Syndrome | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Acute respiratory failure | 1/34 (2.9%) | 1 | 0/70 (0%) | 0 |
| Dyspnoea | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
| Respiratory failure | 0/34 (0%) | 0 | 1/70 (1.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Docetaxel 75 mg/m^2 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/34 (91.2%) | 66/70 (94.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 7/34 (20.6%) | 9 | 24/70 (34.3%) | 31 |
| Neutropenia | 1/34 (2.9%) | 1 | 12/70 (17.1%) | 16 |
| Eye disorders | ||||
| Lacrimation increased | 2/34 (5.9%) | 2 | 4/70 (5.7%) | 4 |
| Gastrointestinal disorders | ||||
| Nausea | 6/34 (17.6%) | 9 | 26/70 (37.1%) | 45 |
| Diarrhoea | 8/34 (23.5%) | 12 | 16/70 (22.9%) | 20 |
| Constipation | 2/34 (5.9%) | 2 | 13/70 (18.6%) | 16 |
| Stomatitis | 3/34 (8.8%) | 3 | 5/70 (7.1%) | 7 |
| Vomiting | 3/34 (8.8%) | 3 | 5/70 (7.1%) | 6 |
| Abdominal pain upper | 2/34 (5.9%) | 2 | 4/70 (5.7%) | 4 |
| General disorders | ||||
| Asthenia | 10/34 (29.4%) | 11 | 22/70 (31.4%) | 27 |
| Fatigue | 5/34 (14.7%) | 5 | 17/70 (24.3%) | 22 |
| Pyrexia | 6/34 (17.6%) | 8 | 12/70 (17.1%) | 14 |
| Chest pain | 2/34 (5.9%) | 2 | 7/70 (10%) | 7 |
| Mucosal inflammation | 3/34 (8.8%) | 5 | 4/70 (5.7%) | 5 |
| Oedema peripheral | 1/34 (2.9%) | 1 | 5/70 (7.1%) | 5 |
| Pain | 1/34 (2.9%) | 2 | 4/70 (5.7%) | 4 |
| Infections and infestations | ||||
| Respiratory tract infection | 1/34 (2.9%) | 1 | 5/70 (7.1%) | 5 |
| Oral candidiasis | 3/34 (8.8%) | 3 | 2/70 (2.9%) | 2 |
| Urinary tract infection | 1/34 (2.9%) | 1 | 4/70 (5.7%) | 4 |
| Investigations | ||||
| Weight decreased | 3/34 (8.8%) | 3 | 6/70 (8.6%) | 6 |
| Blood alkaline phosphatase increased | 2/34 (5.9%) | 2 | 5/70 (7.1%) | 5 |
| Neutrophil count decreased | 2/34 (5.9%) | 2 | 5/70 (7.1%) | 9 |
| Alanine aminotransferase increased | 3/34 (8.8%) | 3 | 3/70 (4.3%) | 5 |
| Blood creatinine increased | 1/34 (2.9%) | 1 | 5/70 (7.1%) | 7 |
| Blood lactate dehydrogenase increased | 1/34 (2.9%) | 1 | 4/70 (5.7%) | 5 |
| Aspartate aminotransferase increased | 2/34 (5.9%) | 2 | 2/70 (2.9%) | 2 |
| White blood cell count decreased | 0/34 (0%) | 0 | 4/70 (5.7%) | 10 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 4/34 (11.8%) | 4 | 19/70 (27.1%) | 20 |
| Hyperglycaemia | 0/34 (0%) | 0 | 5/70 (7.1%) | 5 |
| Dehydration | 2/34 (5.9%) | 2 | 2/70 (2.9%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 3/34 (8.8%) | 3 | 10/70 (14.3%) | 13 |
| Arthralgia | 3/34 (8.8%) | 5 | 7/70 (10%) | 7 |
| Back pain | 5/34 (14.7%) | 5 | 2/70 (2.9%) | 2 |
| Muscle spasms | 0/34 (0%) | 0 | 4/70 (5.7%) | 4 |
| Nervous system disorders | ||||
| Paraesthesia | 3/34 (8.8%) | 3 | 9/70 (12.9%) | 11 |
| Neuropathy peripheral | 3/34 (8.8%) | 4 | 5/70 (7.1%) | 5 |
| Dizziness | 2/34 (5.9%) | 2 | 4/70 (5.7%) | 4 |
| Headache | 2/34 (5.9%) | 2 | 4/70 (5.7%) | 4 |
| Psychiatric disorders | ||||
| Insomnia | 2/34 (5.9%) | 2 | 4/70 (5.7%) | 4 |
| Renal and urinary disorders | ||||
| Dysuria | 3/34 (8.8%) | 3 | 0/70 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 4/34 (11.8%) | 5 | 23/70 (32.9%) | 25 |
| Cough | 4/34 (11.8%) | 4 | 14/70 (20%) | 14 |
| Dyspnoea exertional | 2/34 (5.9%) | 2 | 2/70 (2.9%) | 2 |
| Haemoptysis | 0/34 (0%) | 0 | 4/70 (5.7%) | 5 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 7/34 (20.6%) | 7 | 20/70 (28.6%) | 20 |
| Nail disorder | 2/34 (5.9%) | 2 | 5/70 (7.1%) | 5 |
| Pruritus | 0/34 (0%) | 0 | 7/70 (10%) | 7 |
| Rash | 3/34 (8.8%) | 3 | 4/70 (5.7%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| GSKClinicalSupportHD@gsk.com |
- 205801-001
- 2018-001316-29