Trial Outcomes & Findings for Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1 (NCT NCT05553808)

Last Updated: 2023-01-19

Results Overview

Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2023-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel 75 mg/m^2 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).	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Overall Study STARTED	35	70
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	35	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel 75 mg/m^2 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).	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Overall Study Death	25	62
Overall Study Site Closed	6	6
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel 75 mg/m^2 n=35 Participants 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).	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.	Total n=105 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 10.48 • n=5 Participants	64.4 years STANDARD_DEVIATION 9.11 • n=7 Participants	63.8 years STANDARD_DEVIATION 9.57 • n=5 Participants
Age, Customized 18-64	22 Participants n=5 Participants	31 Participants n=7 Participants	53 Participants n=5 Participants
Age, Customized 65-74	7 Participants n=5 Participants	28 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized 75-84	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized >=85	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	53 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	67 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment South Korea	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Romania	2 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Poland	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment France	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Germany	3 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Spain	4 participants n=5 Participants	13 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Russia	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Intent To Treat population (ITT) included all participants who were randomized to treatment regardless of whether the participants actually received study treatment.

Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Overall Survival	8.2 Months Interval 4.5 to 16.1	7.8 Months Interval 4.7 to 10.8

SECONDARY outcome

Timeframe: Month 12 and 18

Population: Intent-To-Treat Population.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months Month 12	44 Percentage of Participants Interval 27.0 to 60.0	28 Percentage of Participants Interval 18.0 to 39.0
Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months Month 18	28 Percentage of Participants Interval 14.0 to 44.0	18 Percentage of Participants Interval 10.0 to 28.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-To-Treat Population.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable Complete Response	0 Participants	0 Participants
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable Partial Response	4 Participants	13 Participants
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable Stable Disease	10 Participants	22 Participants
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable Progressive Disease	14 Participants	23 Participants
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable Not Evaluable	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent to Treat Population. Only those participants with data available at specified data points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=29 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=62 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Kaplan-Meier Estimates of Progression-Free Survival (PFS)	3.3 Months Interval 1.6 to 4.2	3.4 Months Interval 2.6 to 4.3

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-To-Treat Population

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Objective Response Rate	11 Percentage of Participants Interval 3.2 to 26.7	19 Percentage of Participants Interval 10.3 to 29.7

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent To Treat Population. Only participants who achieved Objective Response were evaluated.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=4 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=13 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response	4.8 Months Interval 2.8 to Upper limit was not calculated due to insufficient number of participants with events.	4.3 Months Interval 2.4 to 8.7

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-to-Treat Population.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Disease Control Rate (DCR)	40 Percentage of Participants Interval 23.9 to 57.9	50 Percentage of Participants Interval 37.8 to 62.2

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-To-Treat Population.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
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 iCR	0 Participants	0 Participants
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 iPR	4 Participants	13 Participants
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 iUPD	11 Participants	15 Participants
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 iCPD	3 Participants	8 Participants
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 iSD	10 Participants	22 Participants
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 Not Evaluable	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-to-Treat population. Only those participants with data available at specified data points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=29 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=62 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS)	3.3 Months Interval 1.6 to 4.2	3.4 Months Interval 2.6 to 4.3

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-to-Treat population.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=35 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
iRECIST Objective Response Rate (iORR)	11 Percentage of Participants Interval 3.2 to 26.7	19 Percentage of Participants Interval 10.3 to 29.7

SECONDARY outcome

Timeframe: Up to 2 years

Population: Intent-To-Treat Population. Only the participants with Objective Response were evaluated.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=4 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=13 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response	4.8 Months Interval 2.8 to Upper limit was not calculated due to insufficient number of participants with events.	4.3 Months Interval 2.4 to 8.7

SECONDARY outcome

Timeframe: Up to 2 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=34 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=70 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals AEs	34 Participants	70 Participants
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals AESI	1 Participants	4 Participants
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals SAEs	16 Participants	34 Participants
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals AEs leading to permanent discontinuation of study treatment	12 Participants	16 Participants
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals AEs leading to dose reduction	7 Participants	13 Participants
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals AEs leading to dose interruption/delay	11 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety Population. Only those participants with data available at specified data points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=34 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=63 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline Blood bilirubin increased	0 Participants	1 Participants
Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline Hypercalcemia	0 Participants	2 Participants
Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline Creatinine increased	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety Population. Only those participants with data available at specified data points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=34 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=64 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline Anemia	2 Participants	5 Participants
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline Leukocytosis	0 Participants	1 Participants
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline White blood cell decreased	5 Participants	11 Participants
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline Lymphocyte count decreased	4 Participants	12 Participants
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline Neutrophil count decreased	4 Participants	13 Participants
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline Platelet count decreased	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety Population. Only those participants with data available at specified time points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=34 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=63 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline Diastolic Blood Pressure	12 Participants	26 Participants
Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline Systolic Blood Pressure	16 Participants	28 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety Population. Only those participants with data available at specified data points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=34 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=63 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline Decrease to <=35 Degrees Celsius	0 Participants	6 Participants
Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline Change to Normal or No Change	33 Participants	52 Participants
Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline Increase to >=38 Degrees Celsius	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety Population. Only those participants with data available at specified data points have been analyzed.

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.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=34 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=63 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline Decrease to <50 beats per minute	0 Participants	0 Participants
Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline Change to Normal or No Change	32 Participants	55 Participants
Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline Increase to >120 beats per minute	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 1

Population: Pharmacokinetic (PK) population will consist of all participants from the ITT Population from whom a blood sample was obtained and analyzed for PK concentration.

Blood samples were collected for assessment of the pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=67 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Minimum Observed Concentration (CmIn) of Feladilimab	6104.6 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 91.3	—

SECONDARY outcome

Timeframe: Week 1, Week 13 and Week 25

Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for assessment of the pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=67 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Maximum Observed Concentration (Cmax) of Feladilimab Week 1	24923.7 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 26.7	—
Maximum Observed Concentration (Cmax) of Feladilimab Week 13	28715.9 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 45.4	—
Maximum Observed Concentration (Cmax) of Feladilimab Week 25	32688.4 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 27.4	—

SECONDARY outcome

Timeframe: Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for assessment of the pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=30 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 n=55 Participants Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Maximum Observed Concentration (Cmax) of Docetaxel Week 1	1500.9 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 133.5	1429.9 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 138.7
Maximum Observed Concentration (Cmax) of Docetaxel Week 4	1587.1 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 128.6	1399.7 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 99.3
Maximum Observed Concentration (Cmax) of Docetaxel Week 7	846.8 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 166.4	1036.9 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 171.2
Maximum Observed Concentration (Cmax) of Docetaxel Week 10	1262.9 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 155.4	1248.4 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 118.3
Maximum Observed Concentration (Cmax) of Docetaxel Week 13	1354.2 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 212.1	1363.4 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 137.8
Maximum Observed Concentration (Cmax) of Docetaxel Week 16	1095.3 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 114.3	1381.9 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 114.0
Maximum Observed Concentration (Cmax) of Docetaxel Week 19	759.0 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 74.0	1765.7 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 95.1
Maximum Observed Concentration (Cmax) of Docetaxel Week 22	535.5 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 10.9	2430.7 nanogram per millimeter (ng/mL) Geometric Coefficient of Variation 73.3

SECONDARY outcome

Timeframe: Up to 2 years

Population: Data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Outcome measures

Outcome measures
Measure	Docetaxel 75 mg/m^2 n=69 Participants Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m\^2) monotherapy as intravenous (IV) infusion Q3W.	Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 Participants with NSCLC were administered with feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m\^2 IV infusion Q3W.
Number of Participants With Positive ADA Against Feladilimab Week 1	1 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 4	8 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 7	4 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 10	2 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 13	2 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 16	1 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 19	2 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 22	0 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 25	0 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 37	0 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 49	0 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 61	0 Participants	—
Number of Participants With Positive ADA Against Feladilimab Week 73	0 Participants	—

Adverse Events

Docetaxel 75 mg/m^2

Serious events: 16 serious events

Other events: 31 other events

Deaths: 25 deaths

Feladilimab 80 mg Plus Docetaxel 75 mg/m^2

Serious events: 34 serious events

Other events: 66 other events

Deaths: 62 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER