Phase III Study (Tarceva®) vs Chemotherapy to Treat Advan... | NCT00446225

ID	Type	Description	Link
2006-003568-73	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib	Drug: Erlotinib
B	Active Comparator	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. - Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v. day 1. Repeat cycles every 3 weeks. - Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks. In the case of patients not eligible for treatment with cisplatin, cisplatin can be replaced by carboplatin. The schedules will be the following: Docetaxel 75 mg/m2 day 1 and carboplatin AUC = 6 day 1, every 21 days. Gemcitabine 1000 mg/m2 days 1 and 8 and carboplatin AUC = 5 day 1, every 21 days. Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.	Drug: Carboplatin Drug: Gemcitabin Drug: Docetaxel Drug: Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erlotinib	Drug	150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free-survival	The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)	From the date of randomization to the date of last follow up, assessed up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response	The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Informed consent
Histologically confirmed diagnosis of NSCLC, non epidermoid, stage IV or IIIB with pleural effusion, or N3 tumours not candidate for thoracic radiotherapy, harbouring deletions in the exon 19 or mutation in the exon 21 in the TK of the EGFR.
Either measurable or evaluable disease.
Age > 18 years.
ECOG performance status < 2.
Adequate bone marrow function
Adequate renal function
Adequate hepatic function
Patients must be accessible for treatment and follow-up.
Patients capable of following an adequate therapeutic compliance
Women of child bearing potential: negative pregnancy test.
Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.
Ability to swallow.
Patients with asymptomatic brain metastasis and stable with medical treatment will be eligible for the study. Patients having received radiotherapy for their brain metastasis prior to the systemic treatment for the NSCLC will be also eligible.
Absence of gastrointestinal tract problems

Exclusion criteria:

Pregnant or lactating women.
Women of child bearing potential having a positive pregnancy test in the basal visit or not accomplishing the test.
Patients of both genders sexually active (at a fertile age) not following contraceptive measures during the study.
Prior chemotherapy for metastatic disease. Both prior neoadjuvant and adjuvant chemotherapy allowed provided that completed â‰¥ 6 months before entering the study.
Prior treatment with EGFR targeted therapies.
Patients may have received radiotherapy, provided that the irradiated lesion is not the only evaluable lesion for response and completed before entering the study.
Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
Any significant ophthalmologic impairment of the eye surface. Use of contact lenses is not recommended.
Pre-existing motor or sensorial neurotoxicity grade > 2, according to the NCI-CTC criteria.
Evidence of spinal cord compression.
Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
Any other severe disease or clinical conditions, as, but not only:
- Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
- History of significant neurological or psychiatric disorders, including dementia and epileptic seizures.
- Uncontrolled active infection.
- Uncontrolled peptic ulcer.
- Unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
- AST and/or ALT > 1.5 x UNL associated to alkaline phosphatase > 2.5 x UNL.
- Any other underlying severe process affecting the ability to take part in the study.
Absolute contraindication for steroids.
Dementia or significant mental disorder interfering the understanding and giving the informed consent.
History of other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, radically treated prostatic carcinoma with good prognostic (Gleason = 6). History of other curatively treated malignancy and no evidence of disease within the past 5 years.

Name	Affiliation	Role
Rafael Rosell i Costa, MD	Spanish Lung Cancer Group	Study Chair
Luis Paz-Ares, MD	Spanish Lung Cancer Group	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire D'Angers		Angers			France
Hôpital Auguste Morvan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22285168	Result	Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.
26181014

Label	URL
Spanish Lung Cancer Group website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
BG001	B: Standard Chemotherapy Group	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00065(53 to 82) BG00165(46 to 82) BG00265(46 to 82)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00058 BG00168 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Italy

Title	Measurements
	BG00011 BG0018 BG002

Smoking status

Count of Participants

Participants

Title

Denominators

Categories

Never smoked

Title	Measurements
	BG00057 BG00163 BG002

ECOG Performance Status Scale

ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability

GRADES:

ECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead

Count of Participants

Participants

Title

Denominators

Categories

ECOG 0

Title	Measurements
	BG00027 BG001

Histological diagnosis

Count of Participants

Participants

Title

Denominators

Categories

Adenocarcinoma

Title	Measurements
	BG00082 BG00178 BG002

Clinical stage

Staging is a classification where cancer is located, if or where it has spread and whether it's affecting other parts of the body.

There are 5 stages for NSCLC:

Stage 0:tumor hasn't grown into nearby normal lung tissues Stage I:small tumor that hasn't spread to any lymph nodes Stage II: medium tumor that hasn't spread to the nearby lymph nodes or N1 Stage III: cancer spread to the lymph nodes but haven't spread to other distant parts of the body Stage IV:cancer has spread to more than 1 area in the other lung, the fluid surrounding the lung or the heart, or distant parts of the body

Count of Participants

Participants

Title

Denominators

Categories

Stage IIIA

Title	Measurements
	BG0001 BG001

Bone metastasis

Bone metastasis in lung cancer occurs when cancer cells spread from the lungs to the bones. This happens when cancer cells break away from the primary lung tumor, travel through the bloodstream or lymphatic system, and establish new tumors in bone tissue.

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00028 BG001

Brain metastasis

Brain metastasis in lung cancer occurs when cancer cells from the lungs spread to the brain. This is a common complication in advanced-stage lung cancer, particularly with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). It happens when cancer cells travel through the bloodstream or lymphatic system and invade brain tissue.

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0009 BG001

Type of EGFR mutation

EGFR (epidermal growth factor receptor) mutations in NSCLC types:

Exon19 Deletions: It leads to the activation of EGFR contributing to cancer cell growth.

Exon21 L858R Mutation: It involves a substitution of leucine for arginine and leads to receptor activation promoting tumor growth.

Exon20 Insertion Mutations: Insertion of small amino acid and are often resistant to EGFR inhibitors.

T790M Mutation: Associated with resistance to TKIs. Exon19-21 Complex Mutations: Across exon 19 & 21.

Testing for EGFR mutations is crucial for selecting the appropriate therapy in cancer treatment.

Count of Participants

Participants

Title

Denominators

Categories

Deletion of exon 19

Title	Measurements
	BG00057 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free-survival

The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)

Posted

Median

95% Confidence Interval

months

From the date of randomization to the date of last follow up, assessed up to 24 months

ID	Title	Description
OG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
OG001	B: Standard Chemotherapy Group	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Units	Counts
Participants	OG00086 OG00187

Title

Denominators

Categories

Title	Measurements
	OG0009.4(7.9 to 12.3) OG0015.2(4.4 to 5.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.0001		Hazard Ratio (HR)	0.42			2-Sided	95	0.27	0.64					Superiority

Secondary

Objective Response

The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0.

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.

Posted

Number

percentage of participants

From the date of randomization to the date of last follow up, assessed up to 24 months

ID	Title	Description
OG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
OG001	B: Standard Chemotherapy Group	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Secondary

Overall Survival

Overall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.

Posted

Median

95% Confidence Interval

months

From the date of randomization to the date of last follow up, assessed up to 24 months

ID	Title	Description
OG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
OG001	B: Standard Chemotherapy Group	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Secondary

Molecular Markers Related to EGFR and Study Pathology

The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.

Intention to treat. Serum sample taken at baseline

Posted

Count of Units

Sample of serum

At baseline

Sample of serum

ID	Title	Description
OG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
OG001	B: Standard Chemotherapy Group	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	A: Erlotinib Group	Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib	55	86	27	86	70	86
EG001	B: Standard Chemotherapy Group	4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.	54	87	25	87	65	87

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0013 events3 affected87 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0011 events1 affected87 at risk
Gastroenteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk
Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected87 at risk
Pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected87 at risk
Subcutaneous abscess	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected86 at risk EG0011 events1 affected87 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0011 events1 affected87 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0011 events1 affected87 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0012 events2 affected87 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected87 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0011 events1 affected87 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0012 events2 affected87 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk
Sigmoiditis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0014 events4 affected87 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0013 events3 affected87 at risk
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected87 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Chest pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Cerebrovascular accident	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0012 events2 affected87 at risk
Ischaemic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Polyneuropathy	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Cardiac tamponade	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0011 events1 affected87 at risk
Cardiac failure	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk
Pericarditis	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected87 at risk
Thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk
Hepatotoxicity	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected87 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected86 at risk EG0010 events0 affected87 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected87 at risk
Confusional state	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected87 at risk

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D009369	Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Term	Organ System	Assessment Type	Statistical Information
Fatigue	General disorders	Non-systematic Assessment	EG00048 events48 affected86 at risk EG00156 events56 affected87 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00066 events66 affected86 at risk EG0014 events4 affected87 at risk
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG00010 events10 affected86 at risk EG00140 events40 affected87 at risk
Alopecia	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00012 events12 affected86 at risk EG00115 events15 affected87 at risk
Aminotransferase rise	Blood and lymphatic system disorders	Non-systematic Assessment	EG0005 events5 affected86 at risk EG0015 events5 affected87 at risk
Neuropathy	Nervous system disorders	Non-systematic Assessment	EG0008 events8 affected86 at risk EG00112 events12 affected87 at risk

ID	Term
D000069347	Erlotinib Hydrochloride
D016190	Carboplatin
D000093542	Gemcitabine
D000077143	Docetaxel
D002945	Cisplatin