Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA
Brief Summary: The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.


Options:
A: Inclusion Criteria:

* More than 18 years of age
* Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
* At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
* ECOG PS 0-2
* At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
* Patients must have adequate hematologic, renal and liver function as defined by Hb \> 9g/dL, neutrophils \> 1000/mm3, platelets \> 50,000/mm3, creatinine \< 2mg/dL, and AST (SGOT) and/or ALT (SGPT) \< 5 x UNL (upper normal limit).
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
* Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

* Patients with tumor harboring EGFR mutation.
* Prior systemic therapy for NSCLC
* Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
* Symptomatic brain metastasis. Brain metastases stable \< 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
* Major surgery within 3 weeks prior to study enrollment.
* Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
* Severe medical illness or active infection that would impair the ability to receive gefitinib.
* Pregnancy or breast feeding.
B: Inclusion Criteria:

* Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
* Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
* Patients with documented 'acquired resistance' on first line gefitinib
* Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
* Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

* Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). Palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity).
* Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
* Any evidence of severe of uncontrolled systemic disease Treatment with an investigational drug within 4 weeks before randomization
C: Inclusion Criteria:

* Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
* Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
* WHO performance status (PS) 0-2
* Absolute Neutrophil Count (ANC) \>1.5 x 109/liter (L) and platelets \>100 x 109/L
* Life expectancy of at least 8 weeks

Exclusion Criteria:

* Prior ZD1839 therapy
* Prior docetaxel treatment for NSCLC
* Less than 14 days since completion of prior radiotherapy
* Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
* Evidence of clinically active Interstitial Lung Disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
* Patients with pre existing peripheral neuropathy \>= grade 2 (NCI CTC criteria)
D: 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.

Answer: B