Trial Outcomes & Findings for Switch Maintenance Pembrolizumab in Patients With NSCLC After First Line Platinum Doublet Chemotherapy (NCT NCT02705820)

Last Updated: 2025-06-17

Results Overview

To investigate whether treatment with pembrolizumab improves 1 year irPFS, compared to historical controls (from the Pemetrexed and Erlotinib maintenance trials). Aim to show that this is at least 25% (compared to an expected 12% 1 year PFS based on the Pemetrexed and Erlotinib maintenance trials) using a one stage phase II Fleming's design.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

4 years

Results posted on

2025-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Study experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Overall Study STARTED	48
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Study experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Overall Study Death	2
Overall Study Disease Progression	34
Overall Study Clinical Deterioration	3

Baseline Characteristics

Switch Maintenance Pembrolizumab in Patients With NSCLC After First Line Platinum Doublet Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Age, Continuous	66 years n=5 Participants
Age, Customized <70 years	30 Participants n=5 Participants
Age, Customized ≥70 years	18 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	47 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Number of Participants	48 participant n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Immune Related Progression Free Survival (irPFS) at 1 Year	16 Participants

SECONDARY outcome

Timeframe: 7 years

Population: In order to be eligible for trial entry, patients must have a diagnosis of metastatic Non Small Cell Lung Cancer, and should not have progressed after first line palliative chemotherapy with a platinum doublet. They should have received no more than six (6) cycles of a platinum doublet chemotherapy, and should be able to receive treatment within three (3) to six (6) weeks from the last chemotherapy administration.

Response rates according to RECIST criteria Version 1.1 where Complete response(CR): Disappearance of all target lesions. Partial response(PR): At least a 30% decrease in the sum of diameters of all target lesions, (from baseline sum of diameters in the absence of CR). Progressive disease(PD): Any new lesion or at least a 20% increase in the sum of diameters of target lesions, (from the smallest sum of diameters at prior timepoints -including baseline). Stable disease(SD): Neither CR or a PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Response Rates Using RECIST Version 1.1 Complete Response	1 Participants
Response Rates Using RECIST Version 1.1 Partial Response	6 Participants
Response Rates Using RECIST Version 1.1 Non- Responders	41 Participants

SECONDARY outcome

Timeframe: 7 years

Response rates according to RECIST criteria. Time from randomization of the first patient until database cut-off date for the final analysis (Jul 2016 - May 2023; approximately 7 years).

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Response Rates With Immune Related Response Criteria (irRC) Complete Response	1 Participants
Response Rates With Immune Related Response Criteria (irRC) Partial Response	6 Participants
Response Rates With Immune Related Response Criteria (irRC) Non Responders	41 Participants

SECONDARY outcome

Timeframe: 7 years

PFS calculated using RECIST criteria. RECIST Criteria Version 1.1: Complete response(CR): Disappearance of all target lesions. Partial response(PR): At least a 30% decrease in the sum of diameters of all target lesions, (from baseline sum of diameters in the absence of CR). Progressive disease(PD): Any new lesion or at least a 20% increase in the sum of diameters of target lesions, (from the smallest sum of diameters at prior timepoints -including baseline). Stable disease(SD): Neither CR or a PR nor sufficient increase to qualify for PD. Immune related irPFS calculated using Immune related Response criteria where upon PD there a CT scan would be repeated in 4-6 weeks to exclude pseudoprogression..

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Radiological Progression Free Survival (PFS) Using RECIST Criteria Version 1.1	2.1 months Interval 0.0 to 4.2

SECONDARY outcome

Timeframe: 7 years

PFS calculated using RECIST criteria. Immune related irPFS calculated using Immune related Response criteria.

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Immune-related PFS Using irRC	6.3 months Interval 4.2 to 8.4

SECONDARY outcome

Timeframe: 7 years

Defined as time from the date of randomisation until death from any cause or time to the last follow up appointment (censored).

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Overall Survival	12.2 months Interval 7.8 to 16.6

SECONDARY outcome

Timeframe: 7 years

Assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period. Adverse events are collected from study treatment initiation to 30 days after treatment is ceased for any reason. Serious adverse events and events of clinical interest are collected within 90 days after last dose of trial treatment.

Outcome measures

Outcome measures
Measure	Single Arm Study n=48 Participants experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Experienced any adverse event (any grade)	48 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Experienced treatment related adverse event (any grade)	42 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Experienced treatment related adverse event of grade 3-5	11 Participants

Adverse Events

Single Arm Study

Serious events: 13 serious events

Other events: 48 other events

Deaths: 42 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Study n=48 participants at risk experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Cardiac disorders Hypotension	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Cardiac disorders Myocardial Infarction	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Cardiac disorders Pericardial Effusion	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Endocrine disorders Adrenal Insufficiency	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Endocrine disorders Hyperglycaemia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Constipation	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
General disorders Fever	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Infections and Infestations	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hypercalcemia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Left Hip Fracture	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Weakness of lower limb	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Nervous system disorders Brachial Plexopathy	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
General disorders Multi organ failure	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.

Other adverse events

Other adverse events
Measure	Single Arm Study n=48 participants at risk experimental treatment with maintenance pembrolizumab Pembrolizumab: Switch maintenance pembrolizumab treatment
Blood and lymphatic system disorders Platelet count decreased	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Blood and lymphatic system disorders Neutrophil count decreased	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Blood and lymphatic system disorders Anemia	18.8% 9/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Cardiac disorders Non-Cardiac chest Pain	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Cardiac disorders Hypertension	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Cardiac disorders Hypotension	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Cardiac disorders Pericardial effusion	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Endocrine disorders Adrenal insufficiency	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Endocrine disorders Hypothyroism	12.5% 6/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Endocrine disorders Hyperthyroism	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Vomiting	8.3% 4/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Gastroesophageal Reflux	8.3% 4/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Constipation	43.8% 21/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Colitis	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Diarrhea	10.4% 5/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Abdominal pain	8.3% 4/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Gastrointestinal disorders Nausea/dizziness	18.8% 9/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
General disorders Pain	25.0% 12/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
General disorders Malaise	54.2% 26/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Lung Infections	16.7% 8/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Bronchial Infection	12.5% 6/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Urinary Tract infection	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Otitis external	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Infection NOS	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Gum Infection	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Upper Respiratory Infection	8.3% 4/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Herpes Zoster	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Fungus Infection	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Infections and infestations Non -neutropenic infection	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hypocalcemia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hypercalcemia	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hypokalemia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hypomagnesemia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Dehydration	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Dysgeusia	8.3% 4/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Anorexia	52.1% 25/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Alanine Transaminase (ALT)	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hypoalbuminemia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Weight Loss	27.1% 13/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Metabolism and nutrition disorders Hyponatremia	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Arthralgia	56.2% 27/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Neuralgia	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 12/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Fracture	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Muscle weakness of lower limbs	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Peripheral sensor neuropathy	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Nervous system disorders Dysarthria	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Psychiatric disorders Confusion	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Psychiatric disorders Depression	10.4% 5/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Psychiatric disorders Anxiety	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Renal and urinary disorders Creatinine increase	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Renal and urinary disorders Cystitis Noninfectious	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Renal and urinary disorders Haematuria	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Renal and urinary disorders Urinary Frequency	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Renal and urinary disorders Urinary Retention	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Cough	45.8% 22/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Flu like Syndrome	4.2% 2/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Bronchial Stricture	8.3% 4/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Telangiectasias	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Pruritus	16.7% 8/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Dry Skin	35.4% 17/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Skin and Subcutaneous tissue disorders: other	6.2% 3/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Rash maculopapular	16.7% 8/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.
Vascular disorders Superficial Thrombophlebitis	2.1% 1/48 • Time from randomization of the first patient until database cut-off date for the OS analysis (Jul 2016 - May 2023; approximately 7 years). In the 'All-Cause Mortality' and the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, number of at risk patients includes all randomized patients, as all patients received at least one dose of trial treatment.

Additional Information

Dr. Harris Charalambous

Bank Of Cyprus Oncology Centre

Phone: +35722847300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place