Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Brief Summary: The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.


Options:
A: Inclusion Criteria:

* KRAS-Wildtype status
* Histologically confirmed adenocarcinoma of the colon or rectum.
* Stage IV disease.
* ECOG 0-2.
* Patients considered suitable for application of chemotherapy.
* Age 18 - 75 years.
* In- or outpatient treatment.
* Estimated life expectancy \> 3 months.
* Measurable index lesion according to RECIST criteria. Evaluation of tumor manifestations ≤ 2 weeks prior to treatment start.
* Effective contraception.
* Adequate hematologic function: leukocytes \>= 3000/µl, neutrophils \>= 1500/µl, platelets \>= 100.000/µ, and hemoglobin \>= 9g/dl.
* Bilirubin \<= 1,5x upper limit of normal (ULN).
* ALAT and ASAT \<= 2,5x ULN, in case of liver metastases \<= 5x ULN.
* Serum creatinine \<= 1,5x ULN.
* No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1 week prior to treatment start. Operation sequels need to be completely healed. Major operations must not be expected at time of study begin, except for potential secondary resection of liver metastases. In case of secondary resection of liver metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.
* No relevant toxicities due to prior medical treatment at time of study entry.

Exclusion Criteria:

* KRAS-Mutation of the tumor
* Prior treatment directed against the epidermal growth factor receptor (EGFR).
* Prior treatment with bevacizumab.
* Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating back \> 6 months prior to study entry.
* Experimental medical treatment within 30 days prior to study entry.
* Known hypersensitivity reaction to any study medication.
* Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG).
* Known or suspected cerebral metastases.
* Clinically significant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia.
* Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.
* Symptomatic peritoneal carcinosis.
* Severe chronic wounds, ulcera or bone fracture.
* Uncontrolled hypertension.
* Severe proteinuria (nephrotic syndrome).
* Arterial thromboembolic events or hemorrhage within 6 months prior to study entry (except tumor bleeding surgically treated by tumor resection).
* Bleeding diatheses or coagulopathy.
* Full dose anticoagulation.
* Known DPD-deficiency (special screening not required).
* Known glucuronidation-deficiency (special screening not required).
* Medical history of other malignant disease within 5 years prior to study entry, except for basalioma, and in-situ cervical carcinoma if treated with curative intent.
* Known alcohol or drug abuse.
* Medical or psychiatric condition which contradicts participation of study.
* Limited legal capacity.
B: Inclusion Criteria:

* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Inoperable metastatic disease
* Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
* Presence of at least 1 bi-dimensionally measurable index lesion

Exclusion Criteria:

* Previous irinotecan-based chemotherapy
* Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
* Brain metastasis
C: Inclusion Criteria:

* Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
* Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)

Exclusion Criteria:

* Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
* Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
D: Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;
3. Together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases
4. With evidence of tumor EGFR expression and KRAS gene wild-type status;
5. With one measurable tumor.
6. Performance status (ECOG) 0\~1
7. A life expectancy of ≥ 3 months
8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
9. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
10. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
2. Known or suspected extrahepatic metastases.
3. Patients with known hypersensitivity reactions to any of the components of the study treatments.
4. Having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab)
5. Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
6. Acute or sub-acute intestinal occlusion
7. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
8. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
9. Known drug abuse/ alcohol abuse
10. Legal incapacity or limited legal capacity
11. Pre-existing peripheral neuropathy.

Answer: C