Please select the eligibility criteria that correspond to the clinical trial below.
Title: Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)
Brief Summary: The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.


Options:
A: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV);
* No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment);
* ECOG performance status 2;
* Age: \> or = 18 and \< 70 years;
* Life expectancy at least 4 weeks;
* Normal bone marrow, hepatic and renal function defined as: neutrophils \> or = 2000/mm3, PLT \> or = 100,000/mm3, Hb \> or = 10.0 g/dl, Bilirubin \> or = 1.5 times the upper normal limit (UNL), AST and ALT \< or = 3 times the UNL (5 times in the presence of liver metastases), creatinine within normal limits;
* Signed informed consent.

Exclusion Criteria:

* Active systemic infections;
* Severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus);
* Inadequate hepatic or renal function;
* Radiation therapy ongoing or concluded within two weeks prior to enrollment;
* Symptomatic cerebral metastases;
* Previous chemotherapy for advanced disease;
* Any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures;
* Pregnant or nursing females;
* Any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
B: Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
* Stage IIIB/IV
* No prior chemotherapy
* Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
* Absence or irradiated and stable central nervous system metastatic disease
* Life expectancy of more than 3 months
* Age ≥ 70 years.
* Performance status (WHO) \< 3
* Patients "non-frail" according to comprehensive geriatric assessment
* Adequate bone marrow function (Absolute neutrophil count \> 1000/mm\^3, Platelet count \> 100000/mm\^3, Hemoglobin \> 9gr/mm\^3).
* Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl).
* Adequate cardiac function (LVEF \> 50%).
* Informed consent.

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
* No presence of a reliable care giver
* Other concurrent investigational agents.
C: Inclusion Criteria:

* Confirmed NSCLC
* Stage IV disease at the time of study entry
* Measurable disease at the time of study entry
* Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia)
* Adequate hematologic function, hepatic function, renal function and coagulation function
* If sexually active, must be post-menopausal, surgically sterile, or using effective contraception; and agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication
* Female participants of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

* Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
* Tumor wholly or partially contains small cell lung cancer
* Untreated central nervous system (CNS) metastases, eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to randomization
* Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years
* Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR)
* Receiving concurrent treatment with other anticancer therapy
* Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
* Has radiologically documented evidence of major blood vessel invasion or encasement by cancer
* Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions)
* Ongoing or active infection
* History of significant neurological or psychiatric disorders
* Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia
* Poorly-controlled hypertension
* Experienced any serious Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry
* Receiving chronic daily treatment with aspirin (\> 325 mg/day) or other known inhibitors of platelet function
* Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization
* Elective or a planned major surgery
* Pregnant or lactating
* Any other serious uncontrolled medical disorders or psychological conditions
* Allergy / history of hypersensitivity reaction to any of the treatment components
* History of drug abuse
D: Inclusion Criteria:

* Men and women ≥18 years of age
* Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
* Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
* Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

* Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)
* Subjects with carcinomatous meningitis
* Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
* Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior treatment on the first line study CA184104 first line NSCLC study
* Prior treatment with Docetaxel
* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Treatment with any investigational agent within 14 days of first administration of study treatment

Answer: A