Trial Outcomes & Findings for Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M (NCT NCT02841579)

Last Updated: 2025-01-28

Results Overview

Defined as the percentage of patients who achieved complete response \[CR\] and partial response \[PR\] to treatment in accordance to the revised RECIST guidelines (version 1.1) for target lesions: CR, disappearance of all target lesions; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Through study completion. From baseline up to approximately 28 months.

Results posted on

2025-01-28

Participant Flow

Fifty-one patients were screened of whom 22 patients with advanced NSCLC harbouring pre-treatment sensitising EGFR and Thr790Met mutations were enrolled and started to receive first-line osimertinib.

Participant milestones

Participant milestones
Measure	Osimertinib The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Study STARTED	22
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Osimertinib The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Study Death	1
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	9

Baseline Characteristics

Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=99 Participants
Age, Categorical >=65 years	13 Participants n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	21 Participants n=99 Participants
Race/Ethnicity, Customized Black	1 Participants n=99 Participants
Region of Enrollment Spain	22 Participants n=99 Participants
Smoking history Never	13 Participants n=99 Participants
Smoking history Former	9 Participants n=99 Participants
Tumor stage IIIB	2 Participants n=99 Participants
Tumor stage IV	20 Participants n=99 Participants
Central nervous system metastases Yes	3 Participants n=99 Participants
Central nervous system metastases No	19 Participants n=99 Participants
EGFR sensitizing mutation Ex19del	6 Participants n=99 Participants
EGFR sensitizing mutation Thr790Met	2 Participants n=99 Participants
EGFR sensitizing mutation Leu858Arg	8 Participants n=99 Participants
Tissue EGFR sensitizing mutation Gly719X	3 Participants n=99 Participants
Tissue EGFR sensitizing mutation Ex19del	10 Participants n=99 Participants
Tissue EGFR sensitizing mutation Thr790Met	22 Participants n=99 Participants
Tissue EGFR sensitizing mutation Leu858Arg	9 Participants n=99 Participants

PRIMARY outcome

Timeframe: Through study completion. From baseline up to approximately 28 months.

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Objective Response Rate (ORR)	77.3 percentage of patients Interval 54.6 to 89.3

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Time from the start of treatment to the time of death due to any cause.

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Survival (OS)	28.39 months Interval 25.62 to The median survival of 28.39 months was reached during the study; however, the upper limit of the confidence interval is not available due to an insufficient number of participants with events beyond the median value. Patients who had not experienced the event were censored at their last known follow-up date. This limitation arises because the calculation of the upper limit requires a sufficient number of events after the median, which was not the case in this study.

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Time from the first documented response to documented disease progression or death, in accordance with RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Duration of Response (DoR)	20.0 months Interval 11.2 to The upper limit of the confidence interval for the median Duration of Response (DoR) could not be determined due to an insufficient number of participants with events beyond the observed median.

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Percentage of patients with complete response, partial response or stable disease for a minimum of 24 weeks, assessed in accordance with the modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, during all study period from baseline up to 78 weeks from the time of the first administration dose

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Disease Control Rate	19 Participants

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Number of patients that presented tumor shrinkage

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Tumor Shrinkage	17 Participants

SECONDARY outcome

Timeframe: Baseline

Percentage of patients with a positive sensitizing EGFR mutation in plasma at baseline

Outcome measures

Outcome measures
Measure	Osimertinib n=21 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Plasma EGFR Mutation Status at Baseline	15 Participants

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Percentage of patients who develop anti-drug mutations in plasma

Outcome measures

Outcome measures
Measure	Osimertinib n=12 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Plasma Acquired Resistance to Osimertinib (AZD9291)	7 Participants

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Patient safety and adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) of the U.S. National Cancer Institute (NCI), version 4. Adverse event(s) are those which, according to the protocol or in the opinion of the investigator, can cause serious or permanent damage or which rule out further treatment with the study drug. Grade 3 means severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 means life-threatening consequences; urgent intervention indicated.

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Number of Participants With Grade 3 or 4 Adverse Events and SAEs	10 Participants

SECONDARY outcome

Timeframe: Through study completion. From baseline up to 41 months.

Defined as the period of time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1.

Outcome measures

Outcome measures
Measure	Osimertinib n=22 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Progression-free Survival	23.1 months Interval 14.1 to The median progression-free survival (PFS) was 23.1 months; however, the upper limit of the confidence interval is not available due to an insufficient number of participants who experienced disease progression or death beyond the median value. Patients who had not progressed or died at the time of analysis were censored at their last evaluable assessment.

SECONDARY outcome

Timeframe: Two weeks after the first study dose

Measured by percentage of patients with a positive sensitizing EGFR mutation in plasma two weeks after the first study dose

Outcome measures

Outcome measures
Measure	Osimertinib n=21 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Plasma EGFR Mutation Status at Two Weeks After the First Study Dose	5 Participants

SECONDARY outcome

Timeframe: At the time of disease progression confirmed radiologically or clinically, up to 78 weeks

Measured by percentage of patients with a positive sensitizing EGFR mutation in plasma at disease progression

Outcome measures

Outcome measures
Measure	Osimertinib n=12 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Overall Plasma EGFR Mutation Status at Disease Progression	8 Participants

SECONDARY outcome

Timeframe: At baseline

Measured by percentage of patients with EGFR Thr790Met mutation in plasma at baseline

Outcome measures

Outcome measures
Measure	Osimertinib n=21 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Plasma EGFR Thr790Met Mutation Status at Baseline	2 Participants

SECONDARY outcome

Timeframe: Two weeks after the first study dose

Measured by percentage of patients with EGFR Thr790Met mutation in plasma at two weeks after the first study dose

Outcome measures

Outcome measures
Measure	Osimertinib n=21 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Plasma EGFR Thr790Met Mutation Status at Two Weeks After the First Study Dose	2 Participants

SECONDARY outcome

Timeframe: At the time of disease progression confirmed radiologically or clinically, up to 78 weeks

Measured by percentage of patients with EGFR Thr790Met mutation in plasma at disease progression

Outcome measures

Outcome measures
Measure	Osimertinib n=12 Participants The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Plasma EGFR Thr790Met Mutation Status at Disease Progression	2 Participants

Adverse Events

Osimertinib

Serious events: 10 serious events

Other events: 22 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Osimertinib n=22 participants at risk The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory failure	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Cardiac disorders Atrioventricular block	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Elevated creatine phosphokinase levels in blood	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Bone pain	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Limb pain	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Disease worsening	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Femur fracture	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Hemoptysis	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Metabolism and nutrition disorders Hypercalcaemia	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Gastrointestinal hypomotility	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Paralytic ileus	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Pulmonary infection	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Cardiac disorders Heart failure	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Vascular disorders Peripheral ischemia	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Intestinal obstruction	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Psychiatric disorders Psychotic disorders	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Vomiting	4.5% 1/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).

Other adverse events

Other adverse events
Measure	Osimertinib n=22 participants at risk The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Osimertinib: The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
Gastrointestinal disorders Diarrhoea	77.3% 17/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Asthenia	45.5% 10/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnea	36.4% 8/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Constipation	31.8% 7/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Anorexia	31.8% 7/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Cough	27.3% 6/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	22.7% 5/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Skin and subcutaneous tissue disorders Rash	22.7% 5/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Respiratory tract infection	22.7% 5/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Alopecia	18.2% 4/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Skin and subcutaneous tissue disorders Dry mouth	18.2% 4/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Back pain	18.2% 4/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Abdominal pain	31.8% 7/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Immune system disorders Mucosa inflammation	18.2% 4/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Blood and lymphatic system disorders Anaemia	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Muscle spasm	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Upper respiratory tract infection	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Insomnia	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Dizziness	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Blood and lymphatic system disorders Neutropenia	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Skin and subcutaneous tissue disorders Dry skin	27.3% 6/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Skin and subcutaneous tissue disorders Itching	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Skin and subcutaneous tissue disorders Dry nose	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Skin and subcutaneous tissue disorders Ungual toxicity	13.6% 3/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Nervous system disorders Sensory disturbances	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Psychiatric disorders Anxiety	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Cold	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Nervous system disorders Headache	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Congested nose	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Exertional dyspnoea	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
General disorders Edema	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Vascular disorders Deep vein thrombosis	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory failure	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Gastroenteritis	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Metabolism and nutrition disorders Hyperglycemia	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Urinary tract infections	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Musculoskeletal and connective tissue disorders Myalgia	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Nasopharyngitis	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Nausea	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Blood and lymphatic system disorders Thrombocytopenia	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Infections and infestations Paronychia	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).
Gastrointestinal disorders Elevated transaminase levels	9.1% 2/22 • 42 months Regular investigator and local laboratory assessments were used to determine adverse events. Basic safety visits were performed on day 1 of each cycle every 2 cycles (every 6 weeks).

Additional Information

Dr. Rafael Rosell

Catalan Institute of Oncology, Institut d'Investigació en Ciències, de la Salut Germans Trias i Pujol

Phone: +34 935 543 050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place