Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) (FLEX)

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ClinicalTrials.gov Identifier: NCT00148798

Recruitment Status : Completed

First Posted : September 8, 2005

Results First Posted : October 4, 2011

Last Update Posted : June 25, 2014

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Sponsor:

Information provided by (Responsible Party):

Merck KGaA, Darmstadt, Germany

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Non Small Cell Lung Cancer (NSCLC)
Interventions	Drug: cetuximab + cisplatin + vinorelbine Drug: cisplatin + vinorelbine
Enrollment	1861

Participant Flow

Recruitment Details	First/last subject (informed consent): October 2004/January 2006. Clinical data cut-off: 18 July 2007. Last subject completed 16 May 2012. Subjects randomized at 155 centers; Asia/Australia: 21; Europe: 120; South America: 14.
Pre-assignment Details	Enrolled: 1,861 after consent to epidermal growth factor receptor (EGFR) assessment; 603 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 1,258 screened for eligibility after consent for study procedures; 143 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 1,125 subjects randomized.


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Period Title: Overall Study
Started	557 ^[1]	568 ^[2]
Completed	557	568
Not Completed	0	0
[1] Intent To Treat (ITT) Population [2] ITT Population

Baseline Characteristics

Arm/Group Title		Cetuximab Plus Chemotherapy	Chemotherapy Alone	Total
Arm/Group Description		cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...	Total of all reporting groups
Arm/Group Description		cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	Total of all reporting groups
Overall Number of Baseline Participants		557	568	1125
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	557 participants	568 participants	1125 participants
		59 (18 to 78)	60 (20 to 83)	59 (18 to 83)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	557 participants	568 participants	1125 participants
<18 years		0	0	0
Between 18 and 65 years		385	389	774
>=65 years		172	179	351
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	557 participants	568 participants	1125 participants
	Female	172 30.9%	163 28.7%	335 29.8%
	Male	385 69.1%	405 71.3%	790 70.2%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	557 participants	568 participants	1125 participants
Australia		20	23	43
Hong Kong		2	2	4
Singapore		5	5	10
Korea, Republic of		28	26	54
Taiwan		21	22	43
Austria		9	7	16
Belgium		3	10	13
Bulgaria		12	12	24
Czech Republic		12	17	29
France		25	25	50
Germany		91	88	179
Hungary		21	23	44
Ireland		3	4	7
Netherlands		10	10	20
Poland		59	50	109
Portugal		3	0	3
Russian Federation		23	16	39
Slovakia		8	12	20
Spain		16	13	29
Sweden		6	3	9
Switzerland		10	6	16
Turkey		1	2	3
United Kingdom		23	21	44
Ukraine		56	71	127
Chile		10	16	26
Italy		18	23	41
Argentina		5	2	7
Mexico		9	8	17
Brazil		48	51	99

Outcome Measures

1.Primary Outcome


Title	Overall Survival Time (OS)
Description	Time from randomization to death. Patients without event are censored ...
Description	Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time Frame	Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	557	568
Median (95% Confidence Interval) Unit of Measure: months
	11.3 (9.4 to 12.4)	10.1 (9.1 to 10.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cetuximab Plus Chemotherapy, Chemotherapy Alone
	Comments	Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0441
	Comments	[Not Specified]
	Method	Stratified Log Rank
	Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-free Survival Time
Description	Duration from randomization until radiological progression (based on m...
Description	Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time Frame	Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	557	568
Median (95% Confidence Interval) Unit of Measure: months
	4.8 (4.2 to 5.3)	4.8 (4.4 to 5.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cetuximab Plus Chemotherapy, Chemotherapy Alone
	Comments	To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3869
	Comments	[Not Specified]
	Method	Stratified Log Rank
	Comments	[Not Specified]

3.Secondary Outcome


Title	Best Overall Response Rate
Description	The best overall response rate is defined as the proportion of subject...
Description	The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Time Frame	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	557	568
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	36.4 (32.4 to 40.6)	29.2 (25.5 to 33.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cetuximab Plus Chemotherapy, Chemotherapy Alone
	Comments	The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0101
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

4.Secondary Outcome


Title	Disease Control Rate
Description	The disease control rate is defined as the proportion of subjects havi...
Description	The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
Time Frame	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	557	568
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	72.5 (68.6 to 76.2)	71.5 (67.6 to 75.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cetuximab Plus Chemotherapy, Chemotherapy Alone
	Comments	The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6801
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

5.Secondary Outcome


Title	Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Description	Mean global health status scores (EORTC QLQ-C30) against time for each...
Description	Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Time Frame	at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description

670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	348	322
Least Squares Mean (Standard Error) Unit of Measure: scores on a scale
At baseline	45.72 (2.164)	46.36 (2.138)
At cycle 3	48.33 (2.325)	51.55 (2.464)
At month 6	54.71 (2.729)	52.92 (2.787)

6.Secondary Outcome


Title	Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Description	Mean social functioning scores (EORTC QLQ-C30) against time for each t...
Description	Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
Time Frame	at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	348	322
Least Squares Mean (Standard Error) Unit of Measure: scores on a scale
At baseline	66.17 (2.836)	64.73 (2.825)
At cycle 3	58.05 (2.995)	67.13 (3.138)
At month 6	67.36 (3.449)	66.47 (3.515)

7.Secondary Outcome


Title	A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
Description	Population PK analysis was conducted using non-linear mixed effects mo...
Description	Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.
Time Frame	Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Cetuximab Concentration at End of Infusion Week 1	Cetuximab Concentration Before Infusion Week 7
Arm/Group Description:	[Not Specified]	[Not Specified]
Arm/Group Description:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	454	298
Mean (Standard Deviation) Unit of Measure: ug/mL
	223.1 (64.6)	51.5 (33.1)

8.Secondary Outcome


Title	Safety - Number of Patients Experiencing Any Adverse Event
Description	Please refer to Adverse Events section for further details
Description	Please refer to Adverse Events section for further details
Time Frame	time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Outcome Measure Data

Analysis Population Description

Safety Population


Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description:	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description:	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
Overall Number of Participants Analyzed	548	562
Measure Type: Number Unit of Measure: participants
	545	549

Adverse Events

Time Frame	Time from first dose up to 30 days after the last dose of study treatment.
Adverse Event Reporting Description	Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.

Arm/Group Title	Cetuximab Plus Chemotherapy	Chemotherapy Alone
Arm/Group Description	cetuximab given as an intravenous (...	cisplatin 80mg/m^2 i.v. infusion on...
Arm/Group Description	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
All-Cause Mortality
	Cetuximab Plus Chemotherapy	Chemotherapy Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Cetuximab Plus Chemotherapy	Chemotherapy Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	325/548 (59.31%)	244/562 (43.42%)
Blood and lymphatic system disorders
Anaemia ^† 1	11/548 (2.01%)	12/562 (2.14%)
Febrile bone marrow aplasia ^† 1	4/548 (0.73%)	0/562 (0.00%)
Febrile neutropenia ^† 1	96/548 (17.52%)	67/562 (11.92%)
Granulocytopenia ^† 1	2/548 (0.36%)	1/562 (0.18%)
Leukopenia ^† 1	15/548 (2.74%)	8/562 (1.42%)
Neutropenia ^† 1	47/548 (8.58%)	33/562 (5.87%)
Pancytopenia ^† 1	2/548 (0.36%)	0/562 (0.00%)
Cardiac disorders
Acute myocardial infarction ^† 1	4/548 (0.73%)	0/562 (0.00%)
Angina pectoris ^† 1	0/548 (0.00%)	1/562 (0.18%)
Arrhythmia supraventricular ^† 1	1/548 (0.18%)	0/562 (0.00%)
Atrial fibrillation ^† 1	0/548 (0.00%)	4/562 (0.71%)
Cardiac arrest ^† 1	0/548 (0.00%)	2/562 (0.36%)
Cardiac failure ^† 1	1/548 (0.18%)	2/562 (0.36%)
Cardiac failure acute ^† 1	2/548 (0.36%)	0/562 (0.00%)
Cardiac tamponade ^† 1	1/548 (0.18%)	0/562 (0.00%)
Cardio-respiratory arrest ^† 1	1/548 (0.18%)	0/562 (0.00%)
Cardiogenic shock ^† 1	1/548 (0.18%)	0/562 (0.00%)
Cardiopulmonary failure ^† 1	3/548 (0.55%)	3/562 (0.53%)
Left ventricular failure ^† 1	2/548 (0.36%)	0/562 (0.00%)
Microvascular angina ^† 1	1/548 (0.18%)	0/562 (0.00%)
Myocardial infarction ^† 1	2/548 (0.36%)	1/562 (0.18%)
Myocardial ischaemia ^† 1	1/548 (0.18%)	1/562 (0.18%)
Palpitations ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pericardial effusion ^† 1	2/548 (0.36%)	2/562 (0.36%)
Right ventricular failure ^† 1	0/548 (0.00%)	1/562 (0.18%)
Supraventricular tachycardia ^† 1	0/548 (0.00%)	2/562 (0.36%)
Tachycardia ^† 1	0/548 (0.00%)	1/562 (0.18%)
Tricuspid valve incompetence ^† 1	0/548 (0.00%)	1/562 (0.18%)
Ventricular fibrillation ^† 1	1/548 (0.18%)	1/562 (0.18%)
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula ^† 1	1/548 (0.18%)	0/562 (0.00%)
Ear and labyrinth disorders
Deafness ^† 1	0/548 (0.00%)	1/562 (0.18%)
Vertigo ^† 1	0/548 (0.00%)	1/562 (0.18%)
Eye disorders
Retinal detachment ^† 1	1/548 (0.18%)	1/562 (0.18%)
Gastrointestinal disorders
Abdominal distension ^† 1	1/548 (0.18%)	0/562 (0.00%)
Abdominal pain ^† 1	6/548 (1.09%)	8/562 (1.42%)
Abdominal pain upper ^† 1	2/548 (0.36%)	1/562 (0.18%)
Anal ulcer ^† 1	1/548 (0.18%)	0/562 (0.00%)
Colitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Constipation ^† 1	5/548 (0.91%)	6/562 (1.07%)
Diarrhoea ^† 1	8/548 (1.46%)	5/562 (0.89%)
Dyspepsia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Dysphagia ^† 1	2/548 (0.36%)	0/562 (0.00%)
Enteritis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Faecaloma ^† 1	0/548 (0.00%)	1/562 (0.18%)
Gastric ulcer ^† 1	1/548 (0.18%)	0/562 (0.00%)
Gastrointestinal haemorrhage ^† 1	0/548 (0.00%)	2/562 (0.36%)
Haematemesis ^† 1	2/548 (0.36%)	0/562 (0.00%)
Ileus paralytic ^† 1	1/548 (0.18%)	0/562 (0.00%)
Intestinal obstruction ^† 1	1/548 (0.18%)	0/562 (0.00%)
Intestinal perforation ^† 1	1/548 (0.18%)	0/562 (0.00%)
Melaena ^† 1	0/548 (0.00%)	1/562 (0.18%)
Nausea ^† 1	6/548 (1.09%)	5/562 (0.89%)
Odynophagia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Oesophagitis ^† 1	3/548 (0.55%)	1/562 (0.18%)
Vomiting ^† 1	16/548 (2.92%)	14/562 (2.49%)
General disorders
Asthenia ^† 1	4/548 (0.73%)	2/562 (0.36%)
Chest discomfort ^† 1	0/548 (0.00%)	2/562 (0.36%)
Chest pain ^† 1	7/548 (1.28%)	6/562 (1.07%)
Death ^† 1	2/548 (0.36%)	0/562 (0.00%)
Drug interaction ^† 1	1/548 (0.18%)	0/562 (0.00%)
Fatigue ^† 1	5/548 (0.91%)	2/562 (0.36%)
Gait disturbance ^† 1	0/548 (0.00%)	1/562 (0.18%)
General physical health deterioration ^† 1	22/548 (4.01%)	4/562 (0.71%)
Injection site reaction ^† 1	1/548 (0.18%)	0/562 (0.00%)
Malaise ^† 1	1/548 (0.18%)	1/562 (0.18%)
Mucosal inflammation ^† 1	2/548 (0.36%)	1/562 (0.18%)
Multi-organ failure ^† 1	0/548 (0.00%)	1/562 (0.18%)
Oedema ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pain ^† 1	1/548 (0.18%)	1/562 (0.18%)
Performance status decreased ^† 1	0/548 (0.00%)	1/562 (0.18%)
Pyrexia ^† 1	16/548 (2.92%)	6/562 (1.07%)
Sudden death ^† 1	2/548 (0.36%)	0/562 (0.00%)
Hepatobiliary disorders
Hepatic pain ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hyperbilirubinaemia ^† 1	2/548 (0.36%)	0/562 (0.00%)
Immune system disorders
Anaphylactic reaction ^† 1	3/548 (0.55%)	0/562 (0.00%)
Anaphylactic shock ^† 1	2/548 (0.36%)	0/562 (0.00%)
Drug hypersensitivity ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hypersensitivity ^† 1	5/548 (0.91%)	1/562 (0.18%)
Serum sickness ^† 1	1/548 (0.18%)	0/562 (0.00%)
Infections and infestations
Anal abscess ^† 1	0/548 (0.00%)	1/562 (0.18%)
Bacteraemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Bacterial sepsis ^† 1	0/548 (0.00%)	1/562 (0.18%)
Brain abscess ^† 1	1/548 (0.18%)	0/562 (0.00%)
Bronchitis ^† 1	2/548 (0.36%)	2/562 (0.36%)
Bronchitis bacterial ^† 1	1/548 (0.18%)	0/562 (0.00%)
Bronchopneumonia ^† 1	1/548 (0.18%)	1/562 (0.18%)
Catheter related infection ^† 1	3/548 (0.55%)	0/562 (0.00%)
Cellulitis ^† 1	4/548 (0.73%)	0/562 (0.00%)
Central line infection ^† 1	1/548 (0.18%)	1/562 (0.18%)
Clostridial infection ^† 1	0/548 (0.00%)	1/562 (0.18%)
Clostridium difficile colitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Dengue fever ^† 1	0/548 (0.00%)	1/562 (0.18%)
Diverticulitis ^† 1	0/548 (0.00%)	1/562 (0.18%)
Febrile infection ^† 1	2/548 (0.36%)	0/562 (0.00%)
Gangrene ^† 1	1/548 (0.18%)	0/562 (0.00%)
Gastroenteritis ^† 1	0/548 (0.00%)	1/562 (0.18%)
Infection ^† 1	3/548 (0.55%)	1/562 (0.18%)
Laryngitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Laryngotracheo bronchitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Lobar pneumonia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Lower respiratory tract infection ^† 1	4/548 (0.73%)	2/562 (0.36%)
Lung abscess ^† 1	1/548 (0.18%)	1/562 (0.18%)
Lung infection ^† 1	2/548 (0.36%)	1/562 (0.18%)
Nasopharyngitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Neutropenic infection ^† 1	9/548 (1.64%)	5/562 (0.89%)
Neutropenic sepsis ^† 1	9/548 (1.64%)	5/562 (0.89%)
Parotitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Peritonsillar abscess ^† 1	0/548 (0.00%)	1/562 (0.18%)
Pharyngitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pharyngotonsillitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pneumonia ^† 1	19/548 (3.47%)	13/562 (2.31%)
Pneumonia necrotising ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pneumonia streptococcal ^† 1	1/548 (0.18%)	0/562 (0.00%)
Postoperative wound infection ^† 1	0/548 (0.00%)	1/562 (0.18%)
Pulmonary tuberculosis ^† 1	1/548 (0.18%)	1/562 (0.18%)
Pyothorax ^† 1	1/548 (0.18%)	0/562 (0.00%)
Respiratory tract infection ^† 1	2/548 (0.36%)	2/562 (0.36%)
Sepsis ^† 1	9/548 (1.64%)	3/562 (0.53%)
Septic shock ^† 1	6/548 (1.09%)	0/562 (0.00%)
Staphylococcal infection ^† 1	1/548 (0.18%)	0/562 (0.00%)
Staphylococcal sepsis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Urinary tract infection ^† 1	1/548 (0.18%)	0/562 (0.00%)
Wound infection ^† 1	1/548 (0.18%)	0/562 (0.00%)
Injury, poisoning and procedural complications
Femoral neck fracture ^† 1	1/548 (0.18%)	0/562 (0.00%)
Femur fracture ^† 1	1/548 (0.18%)	0/562 (0.00%)
Lumbar vertebral fracture ^† 1	2/548 (0.36%)	0/562 (0.00%)
Overdose ^† 1	0/548 (0.00%)	1/562 (0.18%)
Investigations
Aspiration bronchial ^† 1	1/548 (0.18%)	0/562 (0.00%)
Blood creatinine increased ^† 1	5/548 (0.91%)	4/562 (0.71%)
Blood glucose abnormal ^† 1	0/548 (0.00%)	1/562 (0.18%)
Blood potassium decreased ^† 1	0/548 (0.00%)	1/562 (0.18%)
Blood urea increased ^† 1	1/548 (0.18%)	0/562 (0.00%)
C-reactive protein increased ^† 1	2/548 (0.36%)	0/562 (0.00%)
Karnofsky scale worsened ^† 1	1/548 (0.18%)	0/562 (0.00%)
Neutrophil count decreased ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pulmonary arterial pressure increased ^† 1	0/548 (0.00%)	1/562 (0.18%)
Weight decreased ^† 1	0/548 (0.00%)	1/562 (0.18%)
White blood cell count decreased ^† 1	2/548 (0.36%)	1/562 (0.18%)
Metabolism and nutrition disorders
Anorexia ^† 1	4/548 (0.73%)	2/562 (0.36%)
Dehydration ^† 1	12/548 (2.19%)	9/562 (1.60%)
Diabetes mellitus ^† 1	1/548 (0.18%)	0/562 (0.00%)
Fluid overload ^† 1	0/548 (0.00%)	1/562 (0.18%)
Hypercreatininaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hyperglycaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hyperkalaemia ^† 1	2/548 (0.36%)	0/562 (0.00%)
Hypocalcaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hypoglycaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hypokalaemia ^† 1	4/548 (0.73%)	0/562 (0.00%)
Hypomagnesaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hyponatraemia ^† 1	2/548 (0.36%)	1/562 (0.18%)
Metabolic acidosis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Back pain ^† 1	2/548 (0.36%)	0/562 (0.00%)
Bone pain ^† 1	0/548 (0.00%)	1/562 (0.18%)
Muscular weakness ^† 1	0/548 (0.00%)	2/562 (0.36%)
Musculoskeletal pain ^† 1	2/548 (0.36%)	1/562 (0.18%)
Neck pain ^† 1	1/548 (0.18%)	0/562 (0.00%)
Pathological fracture ^† 1	2/548 (0.36%)	0/562 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression ^† 1	1/548 (0.18%)	0/562 (0.00%)
Metastases to heart ^† 1	1/548 (0.18%)	0/562 (0.00%)
Metastases to meninges ^† 1	1/548 (0.18%)	0/562 (0.00%)
Neoplasm progression ^† 1	1/548 (0.18%)	0/562 (0.00%)
Testis cancer ^† 1	1/548 (0.18%)	0/562 (0.00%)
Tumour pain ^† 1	2/548 (0.36%)	0/562 (0.00%)
Nervous system disorders
Altered state of consciousness ^† 1	0/548 (0.00%)	1/562 (0.18%)
Cerebellar syndrome ^† 1	0/548 (0.00%)	1/562 (0.18%)
Cerebral artery embolism ^† 1	1/548 (0.18%)	0/562 (0.00%)
Cerebral haemorrhage ^† 1	0/548 (0.00%)	2/562 (0.36%)
Cerebral infarction ^† 1	0/548 (0.00%)	2/562 (0.36%)
Cerebral ischaemia ^† 1	3/548 (0.55%)	0/562 (0.00%)
Cerebrovascular accident ^† 1	2/548 (0.36%)	5/562 (0.89%)
Cognitive disorder ^† 1	1/548 (0.18%)	0/562 (0.00%)
Coma ^† 1	1/548 (0.18%)	0/562 (0.00%)
Convulsion ^† 1	3/548 (0.55%)	0/562 (0.00%)
Coordination abnormal ^† 1	1/548 (0.18%)	1/562 (0.18%)
Depressed level of consciousness ^† 1	0/548 (0.00%)	1/562 (0.18%)
Dizziness ^† 1	2/548 (0.36%)	0/562 (0.00%)
Dysarthria ^† 1	0/548 (0.00%)	1/562 (0.18%)
Embolic cerebral infarction ^† 1	0/548 (0.00%)	1/562 (0.18%)
Epilepsy ^† 1	0/548 (0.00%)	1/562 (0.18%)
Headache ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hemiparesis ^† 1	0/548 (0.00%)	1/562 (0.18%)
Hemiplegia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Horner's syndrome ^† 1	1/548 (0.18%)	0/562 (0.00%)
Monoparesis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Nervous system disorder ^† 1	0/548 (0.00%)	1/562 (0.18%)
Neuralgia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Paraparesis ^† 1	0/548 (0.00%)	2/562 (0.36%)
Paraplegia ^† 1	0/548 (0.00%)	1/562 (0.18%)
Somnolence ^† 1	1/548 (0.18%)	0/562 (0.00%)
Speech disorder ^† 1	2/548 (0.36%)	0/562 (0.00%)
Spinal cord compression ^† 1	1/548 (0.18%)	1/562 (0.18%)
Syncope ^† 1	1/548 (0.18%)	2/562 (0.36%)
Syncope vasovagal ^† 1	1/548 (0.18%)	1/562 (0.18%)
Transverse sinus thrombosis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Psychiatric disorders
Agitation ^† 1	0/548 (0.00%)	1/562 (0.18%)
Confusional state ^† 1	5/548 (0.91%)	4/562 (0.71%)
Depression ^† 1	0/548 (0.00%)	1/562 (0.18%)
Hallucination ^† 1	0/548 (0.00%)	1/562 (0.18%)
Mental disorder ^† 1	0/548 (0.00%)	1/562 (0.18%)
Renal and urinary disorders
Renal colic ^† 1	1/548 (0.18%)	0/562 (0.00%)
Renal failure ^† 1	6/548 (1.09%)	6/562 (1.07%)
Renal failure acute ^† 1	1/548 (0.18%)	1/562 (0.18%)
Renal impairment ^† 1	2/548 (0.36%)	0/562 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ^† 1	1/548 (0.18%)	0/562 (0.00%)
Acute respiratory distress syndrome ^† 1	1/548 (0.18%)	0/562 (0.00%)
Acute respiratory failure ^† 1	0/548 (0.00%)	1/562 (0.18%)
Apnoea ^† 1	2/548 (0.36%)	0/562 (0.00%)
Cough ^† 1	0/548 (0.00%)	1/562 (0.18%)
Dyspnoea ^† 1	18/548 (3.28%)	13/562 (2.31%)
Haemoptysis ^† 1	3/548 (0.55%)	6/562 (1.07%)
Hypoxia ^† 1	0/548 (0.00%)	2/562 (0.36%)
Lung infiltration ^† 1	1/548 (0.18%)	1/562 (0.18%)
Pleural effusion ^† 1	2/548 (0.36%)	4/562 (0.71%)
Pneumonitis ^† 1	1/548 (0.18%)	1/562 (0.18%)
Pneumothorax ^† 1	1/548 (0.18%)	3/562 (0.53%)
Pulmonary embolism ^† 1	20/548 (3.65%)	13/562 (2.31%)
Pulmonary haemorrhage ^† 1	1/548 (0.18%)	2/562 (0.36%)
Pulmonary oedema ^† 1	1/548 (0.18%)	2/562 (0.36%)
Respiratory distress ^† 1	1/548 (0.18%)	0/562 (0.00%)
Respiratory failure ^† 1	14/548 (2.55%)	9/562 (1.60%)
Respiratory tract haemorrhage ^† 1	0/548 (0.00%)	1/562 (0.18%)
Skin and subcutaneous tissue disorders
Erythema ^† 1	1/548 (0.18%)	0/562 (0.00%)
Rash ^† 1	4/548 (0.73%)	0/562 (0.00%)
Rash maculo-papular ^† 1	1/548 (0.18%)	0/562 (0.00%)
Vascular disorders
Arterial occlusive disease ^† 1	0/548 (0.00%)	2/562 (0.36%)
Arterial thrombosis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Axillary vein thrombosis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Deep vein thrombosis ^† 1	9/548 (1.64%)	3/562 (0.53%)
Embolism ^† 1	0/548 (0.00%)	1/562 (0.18%)
Haematoma ^† 1	1/548 (0.18%)	0/562 (0.00%)
Hypertension ^† 1	1/548 (0.18%)	1/562 (0.18%)
Hypertensive crisis ^† 1	1/548 (0.18%)	1/562 (0.18%)
Hypotension ^† 1	5/548 (0.91%)	0/562 (0.00%)
Iliac artery occlusion ^† 1	1/548 (0.18%)	0/562 (0.00%)
Jugular vein thrombosis ^† 1	0/548 (0.00%)	1/562 (0.18%)
Pelvic venous thrombosis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Peripheral ischaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
Phlebitis ^† 1	0/548 (0.00%)	2/562 (0.36%)
Shock ^† 1	1/548 (0.18%)	0/562 (0.00%)
Superior vena caval occlusion ^† 1	1/548 (0.18%)	2/562 (0.36%)
Thrombosis ^† 1	2/548 (0.36%)	2/562 (0.36%)
Varicose vein ^† 1	0/548 (0.00%)	1/562 (0.18%)
Vascular fragility ^† 1	0/548 (0.00%)	1/562 (0.18%)
Vasculitis ^† 1	1/548 (0.18%)	0/562 (0.00%)
Vena cava thrombosis ^† 1	0/548 (0.00%)	1/562 (0.18%)
Venous thrombosis ^† 1	1/548 (0.18%)	1/562 (0.18%)
Visceral arterial ischaemia ^† 1	1/548 (0.18%)	0/562 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (Unspecified)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cetuximab Plus Chemotherapy	Chemotherapy Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	532/548 (97.08%)	537/562 (95.55%)
Blood and lymphatic system disorders
Neutropenia ^† 1	302/548 (55.11%)	324/562 (57.65%)
Anaemia ^† 1	226/548 (41.24%)	264/562 (46.98%)
Leukopenia ^† 1	176/548 (32.12%)	155/562 (27.58%)
Febrile neutropenia ^† 1	36/548 (6.57%)	32/562 (5.69%)
Thrombocytopenia ^† 1	23/548 (4.20%)	30/562 (5.34%)
Ear and labyrinth disorders
Tinnitus ^† 1	49/548 (8.94%)	55/562 (9.79%)
Eye disorders
Conjunctivitis ^† 1	33/548 (6.02%)	6/562 (1.07%)
Gastrointestinal disorders
Nausea ^† 1	291/548 (53.10%)	303/562 (53.91%)
Vomiting ^† 1	214/548 (39.05%)	225/562 (40.04%)
Constipation ^† 1	204/548 (37.23%)	189/562 (33.63%)
Diarrhoea ^† 1	126/548 (22.99%)	103/562 (18.33%)
Stomatitis ^† 1	85/548 (15.51%)	27/562 (4.80%)
Abdominal pain ^† 1	72/548 (13.14%)	72/562 (12.81%)
Dyspepsia ^† 1	68/548 (12.41%)	55/562 (9.79%)
Abdominal pain upper ^† 1	45/548 (8.21%)	37/562 (6.58%)
Dysphagia ^† 1	31/548 (5.66%)	7/562 (1.25%)
General disorders
Fatigue ^† 1	202/548 (36.86%)	181/562 (32.21%)
Pyrexia ^† 1	112/548 (20.44%)	80/562 (14.23%)
Asthenia ^† 1	90/548 (16.42%)	96/562 (17.08%)
Chest pain ^† 1	70/548 (12.77%)	70/562 (12.46%)
Mucosal inflammation ^† 1	56/548 (10.22%)	23/562 (4.09%)
Chills ^† 1	35/548 (6.39%)	19/562 (3.38%)
Injection site reaction ^† 1	33/548 (6.02%)	29/562 (5.16%)
Oedema peripheral ^† 1	29/548 (5.29%)	39/562 (6.94%)
Infections and infestations
Paronychia ^† 1	46/548 (8.39%)	0/562 (0.00%)
Nasopharyngitis ^† 1	37/548 (6.75%)	16/562 (2.85%)
Investigations
Weight decreased ^† 1	75/548 (13.69%)	50/562 (8.90%)
Blood creatinine increased ^† 1	47/548 (8.58%)	49/562 (8.72%)
White blood cell count decreased ^† 1	36/548 (6.57%)	26/562 (4.63%)
Metabolism and nutrition disorders
Anorexia ^† 1	208/548 (37.96%)	202/562 (35.94%)
Hypokalaemia ^† 1	75/548 (13.69%)	49/562 (8.72%)
Hypomagnesaemia ^† 1	54/548 (9.85%)	27/562 (4.80%)
Hypocalcaemia ^† 1	31/548 (5.66%)	10/562 (1.78%)
Musculoskeletal and connective tissue disorders
Pain in extremity ^† 1	53/548 (9.67%)	32/562 (5.69%)
Back pain ^† 1	39/548 (7.12%)	44/562 (7.83%)
Myalgia ^† 1	39/548 (7.12%)	37/562 (6.58%)
Arthralgia ^† 1	30/548 (5.47%)	22/562 (3.91%)
Bone pain ^† 1	29/548 (5.29%)	28/562 (4.98%)
Nervous system disorders
Dizziness ^† 1	82/548 (14.96%)	57/562 (10.14%)
Headache ^† 1	79/548 (14.42%)	60/562 (10.68%)
Peripheral sensory neuropathy ^† 1	49/548 (8.94%)	46/562 (8.19%)
Paraesthesia ^† 1	40/548 (7.30%)	27/562 (4.80%)
Dysgeusia ^† 1	31/548 (5.66%)	33/562 (5.87%)
Psychiatric disorders
Insomnia ^† 1	58/548 (10.58%)	49/562 (8.72%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	101/548 (18.43%)	95/562 (16.90%)
Cough ^† 1	97/548 (17.70%)	80/562 (14.23%)
Haemoptysis ^† 1	45/548 (8.21%)	24/562 (4.27%)
Dysphonia ^† 1	33/548 (6.02%)	14/562 (2.49%)
Pharyngolaryngeal pain ^† 1	31/548 (5.66%)	20/562 (3.56%)
Epistaxis ^† 1	30/548 (5.47%)	15/562 (2.67%)
Skin and subcutaneous tissue disorders
Rash ^† 1	249/548 (45.44%)	17/562 (3.02%)
Alopecia ^† 1	107/548 (19.53%)	107/562 (19.04%)
Dry skin ^† 1	76/548 (13.87%)	9/562 (1.60%)
Dermatitis acneiform ^† 1	75/548 (13.69%)	1/562 (0.18%)
Pruritus ^† 1	64/548 (11.68%)	13/562 (2.31%)
Acne ^† 1	38/548 (6.93%)	2/562 (0.36%)
Skin fissures ^† 1	30/548 (5.47%)	0/562 (0.00%)
Vascular disorders
Phlebitis ^† 1	48/548 (8.76%)	44/562 (7.83%)
Hypertension ^† 1	40/548 (7.30%)	27/562 (4.80%)
Hypotension ^† 1	39/548 (7.12%)	23/562 (4.09%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (Unspecified)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Merck KGaA Communication Center
Organization:	Merck KGaA
Phone:	+49-6151-72-5200
EMail:	service@merckgroup.com

Publications of Results:

Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Eberhardt WE, de Marinis F, Heeger S, Goddemeier T, O'Byrne KJ, Gatzemeier U. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer. 2012 Aug;77(2):376-82. doi: 10.1016/j.lungcan.2012.03.010. Epub 2012 Apr 11.

Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. doi: 10.1016/S1470-2045(11)70318-7. Epub 2011 Nov 4.

O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795-805. doi: 10.1016/S1470-2045(11)70189-9. Epub 2011 Jul 22.

Gatzemeier U, von Pawel J, Vynnychenko I, Zatloukal P, de Marinis F, Eberhardt WE, Paz-Ares L, Schumacher KM, Goddemeier T, O'Byrne KJ, Pirker R. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol. 2011 Jan;12(1):30-7. doi: 10.1016/S1470-2045(10)70278-3. Epub 2010 Dec 17.

Layout table for additonal information

Responsible Party:	Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT00148798
Other Study ID Numbers:	EMR 62202-046
First Submitted:	September 7, 2005
First Posted:	September 8, 2005
Results First Submitted:	August 24, 2011
Results First Posted:	October 4, 2011
Last Update Posted:	June 25, 2014

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