NCT05553808 is a Phase 2 clinical trial of Docetaxel in Neoplasms, sponsored by GlaxoSmithKline.

Who is sponsoring NCT05553808?

NCT05553808 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT05553808?

Interventions in NCT05553808: Docetaxel, Feladilimab.

Is NCT05553808 still recruiting?

NCT05553808 is currently completed. Last updated 19 January 2023.

Are results published for NCT05553808?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-19 · How we verify

NCT05553808

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 19 January 2023

What this trial tests

Phase 2 trial testing Docetaxel in Neoplasms in 105 participants. Completed in 23 September 2021.

Timeline

24 January 2019

Primary endpoint
23 September 2021

23 September 2021

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	24 January 2019
Primary completion	23 September 2021
Estimated completion	23 September 2021
Sites	43 locations across France, Italy, Netherlands, Russia, Sweden, Germany, Poland, South Korea

Drugs / interventions tested

Docetaxel (Docetaxel) — full drug profile →
Feladilimab — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival Primary · Up to 2 years

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

Group	Value	95% CI
Docetaxel 75 mg/m^2	8.2	4.5 – 16.1
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	7.8	4.7 – 10.8

Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months Secondary · 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.

Month 12

Group	Value	95% CI
Docetaxel 75 mg/m^2	44	27 – 60
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	28	18 – 39

Month 18

Group	Value	95% CI
Docetaxel 75 mg/m^2	28	14 – 44
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	18	10 – 28

Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable Secondary · 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 Di

Complete Response

Group	Value	95% CI
Docetaxel 75 mg/m^2	0
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	0

Partial Response

Group	Value	95% CI
Docetaxel 75 mg/m^2	4
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	13

Stable Disease

Group	Value	95% CI
Docetaxel 75 mg/m^2	10
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	22

Progressive Disease

Group	Value	95% CI
Docetaxel 75 mg/m^2	14
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	23

Not Evaluable

Group	Value	95% CI
Docetaxel 75 mg/m^2	7
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	12

Kaplan-Meier Estimates of Progression-Free Survival (PFS) Secondary · 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.

Group	Value	95% CI
Docetaxel 75 mg/m^2	3.3	1.6 – 4.2
Feladilimab 80 mg Plus Docetaxel 75 mg/m2	3.4	2.6 – 4.3

Objective Response Rate Secondary · 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.

Group	Value	95% CI
Docetaxel 75 mg/m^2	11	3.2 – 26.7
Feladilimab 80 mg Plus Docetaxel 75 mg/m2	19	10.3 – 29.7

Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response Secondary · 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.

Group	Value	95% CI
Docetaxel 75 mg/m^2	4.8	2.8 – NA
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	4.3	2.4 – 8.7

Disease Control Rate (DCR) Secondary · 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 incr

Group	Value	95% CI
Docetaxel 75 mg/m^2	40	23.9 – 57.9
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	50	37.8 – 62.2

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 Secondary · 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

iCR

Group	Value	95% CI
Docetaxel 75 mg/m^2	0
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	0

iPR

Group	Value	95% CI
Docetaxel 75 mg/m^2	4
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	13

iUPD

Group	Value	95% CI
Docetaxel 75 mg/m^2	11
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	15

iCPD

Group	Value	95% CI
Docetaxel 75 mg/m^2	3
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	8

iSD

Group	Value	95% CI
Docetaxel 75 mg/m^2	10
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	22

Not Evaluable

Group	Value	95% CI
Docetaxel 75 mg/m^2	7
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	12

Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS) Secondary · 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 met

Group	Value	95% CI
Docetaxel 75 mg/m^2	3.3	1.6 – 4.2
Feladilimab 80 mg Plus Docetaxel 75 mg/m2	3.4	2.6 – 4.3

iRECIST Objective Response Rate (iORR) Secondary · 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.

Group	Value	95% CI
Docetaxel 75 mg/m^2	11	3.2 – 26.7
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	19	10.3 – 29.7

Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response Secondary · 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.

Group	Value	95% CI
Docetaxel 75 mg/m^2	4.8	2.8 – NA
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	4.3	2.4 – 8.7

Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals Secondary · 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

AEs

Group	Value	95% CI
Docetaxel 75 mg/m^2	34
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	70

AESI

Group	Value	95% CI
Docetaxel 75 mg/m^2	1
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	4

SAEs

Group	Value	95% CI
Docetaxel 75 mg/m^2	16
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	34

AEs leading to permanent discontinuation of study treatment

Group	Value	95% CI
Docetaxel 75 mg/m^2	12
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	16

AEs leading to dose reduction

Group	Value	95% CI
Docetaxel 75 mg/m^2	7
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	13

AEs leading to dose interruption/delay

Group	Value	95% CI
Docetaxel 75 mg/m^2	11
Feladilimab 80 mg Plus Docetaxel 75 mg/m^2	24

Adverse events — posted to ClinicalTrials.gov

Time frame: All cause mortality, non-SAEs and SAEs were collected up to 2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Docetaxel 75 mg/m^2

Serious: 16/34 (47%)

Deaths: 25/34

Feladilimab 80 mg Plus Docetaxel 75 mg/m^2

Serious: 34/70 (49%)

Deaths: 62/70

Serious adverse events (49 terms)

Reaction	System	Docetaxel 75 mg/m^2	Feladilimab 80 mg Plus Doc…
Pneumonia	Infections and infestations	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
COVID-19	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—
Asthenia	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Bronchitis	Infections and infestations	—	—
Diarrhoea infectious	Infections and infestations	—	—
Lung abscess	Infections and infestations	—	—
Pneumocystis jirovecii pneumonia	Infections and infestations	—	—
Pneumonia mycoplasmal	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Acute respiratory distress Syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (48 terms — click to expand)

Reaction	System	Docetaxel 75 mg/m^2	Feladilimab 80 mg Plus Doc…
Nausea	Gastrointestinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Asthenia	General disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Fatigue	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Paraesthesia	Nervous system disorders	—	—
Chest pain	General disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Weight decreased	Investigations	—	—
Oedema peripheral	General disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Blood creatinine increased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Neuropathy peripheral	Nervous system disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Mucosal inflammation	General disorders	—	—
Pain	General disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Blood lactate dehydrogenase increased	Investigations	—	—
White blood cell count decreased	Investigations	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Pneumonia, Febrile neutropenia, Pulmonary embolism, COVID-19, Anaemia, Neutropenia, Pneumonitis, Haemoptysis.

Data from ClinicalTrials.gov NCT05553808 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Integration of immunogenic cell death in the treatment landscape of non-small cell lung cancer: harnessing the power of the immune system.
Liu Z, Xu X, Wang M, Zhang J, et al · · 2026 · PMID 41851096 · DOI 10.1038/s41420-026-03012-2

Verify or expand the search:

Other trials of Docetaxel

Trials testing the same drug.

NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07361484 — Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy a · Phase 3 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07487896 — A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esopha · Phase 3 · not yet recruiting

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05553808 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 19 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05553808.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing