Trial Outcomes & Findings for Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer (NCT NCT01350817)
NCT ID: NCT01350817
Last Updated: 2026-05-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
at 15 weeks
Results posted on
2026-05-15
Participant Flow
One hundred fifty six patients were recruited by 33 public hospitals centers between june 2011 and February 2013, of whom 151 were ran-domized.
3 patients did not meet inclusion criteria, 1 patient Refused to participate 1 patient
Participant milestones
| Measure |
Docetaxel
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
75
|
|
Overall Study
COMPLETED
|
74
|
73
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel
n=74 Participants
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 Participants
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 7.6 • n=11 Participants
|
59.1 years
STANDARD_DEVIATION 8.5 • n=9 Participants
|
59.4 years
STANDARD_DEVIATION 8 • n=20 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=11 Participants
|
14 Participants
n=9 Participants
|
32 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=11 Participants
|
59 Participants
n=9 Participants
|
115 Participants
n=20 Participants
|
|
Region of Enrollment
France
|
74 participants
n=11 Participants
|
73 participants
n=9 Participants
|
147 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: at 15 weeksOutcome measures
| Measure |
Docetaxel
n=74 Participants
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 Participants
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Progression Free Survival at 15 Weeks.
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Docetaxel
n=74 Participants
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 Participants
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Survival Rate at 12 Months
|
37.8 percentage of people
Interval 26.9 to 48.7
|
35.6 percentage of people
Interval 24.9 to 46.5
|
SECONDARY outcome
Timeframe: 12 moisOutcome measures
| Measure |
Docetaxel
n=74 Participants
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 Participants
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Overall Survival
|
8.3 months
Interval 4.5 to 11.1
|
6.5 months
Interval 4.43 to 10.1
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Docetaxel
n=74 Participants
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 Participants
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Progression-free Survival
|
2.5 months
Interval 1.6 to 2.8
|
2.2 months
Interval 1.5 to 2.7
|
Adverse Events
Docetaxel
Serious events: 66 serious events
Other events: 52 other events
Deaths: 6 deaths
Erlotinib
Serious events: 69 serious events
Other events: 71 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Docetaxel
n=74 participants at risk
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 participants at risk
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Infections and infestations
Device related infection
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Furuncle
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Lung abscess
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Axonal neuropathy
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Cerebellar syndrome
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Tremor
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Pericardial haemorrhage
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Pulmonary embolism
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Superior vena cava syndrome
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Haematemesis
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Surgical and medical procedures
Brain tumour operation
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Surgical and medical procedures
Medical device change
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/74 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
4.1%
3/73 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
2/74 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
6.8%
5/73 • Number of events 5 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/74 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Psychiatric disorders
Confusional state
|
2.7%
2/74 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
5/74 • Number of events 7 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
4.1%
3/73 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.7%
2/74 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
4.1%
3/74 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Anal fistula
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Asthenia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Chest pain
|
1.4%
1/74 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Death
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Disease progression
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Febrile bone marrow aplasia
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Febrile neutropenia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
General physical health deterioration
|
13.5%
10/74 • Number of events 10 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
13.7%
10/73 • Number of events 12 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Hyperthermia
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
4.1%
3/73 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Mucosal inflammation
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Pain
|
2.7%
2/74 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
0.00%
0/73 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders and administration site conditions
Pyrexia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
2.7%
2/73 • Number of events 2 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/74 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
Other adverse events
| Measure |
Docetaxel
n=74 participants at risk
Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.
|
Erlotinib
n=73 participants at risk
Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.1%
3/74 • Number of events 3 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
6.8%
5/73 • Number of events 5 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.7%
19/74 • Number of events 46 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
30.1%
22/73 • Number of events 34 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.1%
3/74 • Number of events 6 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
11.0%
8/73 • Number of events 11 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.4%
4/74 • Number of events 4 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
16.4%
12/73 • Number of events 12 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders
Fatigue
|
10.8%
8/74 • Number of events 8 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
15.1%
11/73 • Number of events 12 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.5%
10/74 • Number of events 11 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
11.0%
8/73 • Number of events 9 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders
Pain
|
5.4%
4/74 • Number of events 5 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
1.4%
1/73 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
|
General disorders
Anorexia
|
1.4%
1/74 • Number of events 1 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
5.5%
4/73 • Number of events 5 • Adverse Events were collected from enrollment until end of follow-up, up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place