Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients must not have severe infections within 28 days prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients must not have severe infections within 28 days prior to step 1 registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
GENERAL: Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to start of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Severe infections within 4 weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1 day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Active tuberculosis or severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections =< 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks of first study treatment including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients who have severe infections within 4 weeks before initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia;\r\n* Exception: uncomplicated urinary tract infection will not be considered as a severe infection in these patients
Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Severe infections =< 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to week 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\r\n* Any course of oral or IV antibiotics must have been completed at least 2 weeks prior to the first dose of study medications
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1 including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Signs or symptoms of serious active infection requiring oral or i.v. antibiotics within 2 weeks prior to cycle 1 day 1 and/or hospitalization at study entry including, but not limited to, hospitalization for complications of infection, bacteremia, active tuberculosis or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1 including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infection requiring systemic treatment within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 28 days prior to Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or active tuberculosis
Patient must not have an intercurrent illness likely to interfere with protocol therapy
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
Significant intercurrent illness that will limit the patient's ability to participate in the study
Patient has uncontrolled intercurrent illness
Concurrent or Intercurrent Illness:
Uncontrolled intercurrent illness judged by the treating investigator to preclude treatment with chemotherapy
Uncontrolled intercurrent illness including
Subjects must have no uncontrolled intercurrent illness
Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness
Significant intercurrent illness
Other uncontrolled intercurrent illness that would limit adherence to study requirements
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic
Subjects with serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the Investigator as high risk for investigational drug treatment
Uncontrolled concurrent serious illness
Subjects with a history of serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the investigator as high risk for investigational drug treatment
Uncontrolled intercurrent illness
Uncontrolled intercurrent illness
Significant uncontrolled intercurrent illness that will limit the patient's ability to participate in the study
Uncontrolled concurrent serious illness
Uncontrolled intercurrent illness
Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
Uncontrolled intercurrent illness including, but not limited to:
Other serious intercurrent illness
Uncontrolled intercurrent illness
No uncontrolled intercurrent illness or infection
Uncontrolled intercurrent illness including active infection
Uncontrolled significant intercurrent illness that would preclude the patient from study participation per investigator assessment
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
Uncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalization
History of uncontrolled intercurrent illness:
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection
Severe or uncontrolled intercurrent illness/infection
Uncontrolled intercurrent illness.
Subjects must have no uncontrolled intercurrent illness
Uncontrolled concurrent illness;
Uncontrolled intercurrent illness including, but not limited to:
Uncontrolled intercurrent illness
Uncontrolled intercurrent illness.
Uncontrolled intercurrent illness as outlined in protocol
Uncontrolled concurrent disease or illness
Uncontrolled intercurrent illness.
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. Treatment of pre-existing invasive fungal infections must be completed prior to starting treatment.
Uncontrolled intercurrent illness
Subjects with serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the Investigator as high risk for investigational drug treatment
Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible
Uncontrolled intercurrent illness
Uncontrolled intercurrent illness;
Uncontrolled intercurrent illness
Other serious intercurrent illness
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection
Uncontrolled intercurrent illness
Any significant uncontrolled intercurrent systemic illness
Concurrent uncontrolled illness not related to cancer, including but not limited to:
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
Significant uncontrolled intercurrent illness
Uncontrolled intercurrent illness
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, or need for ventilatory support
Concurrent uncontrolled illness not related to cancer, including but not limited to:
Uncontrolled intercurrent illness
Uncontrolled intercurrent illness (i.e., active infection) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the patient's ability to participate
Uncontrolled intercurrent illness (i.e., active infection ? Grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate.
Any uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study.
Uncontrolled intercurrent illness
Patients must not have a serious intercurrent illness including, but not limited to:
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Uncontrolled intercurrent illness including, but not limited to:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
Uncontrolled intercurrent illness per protocol
Significant intercurrent illness defined as an illness that may result in the subject's death prior to their death from non-squamous NSCLC and/or significantly limit their ability to comply with the requirements of this study
Uncontrolled systemic disease or intercurrent illness
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
Serious or uncontrolled intercurrent illness
Has a significant uncontrolled intercurrent illness including, but not limited to:
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
Uncontrolled concurrent illness
Uncontrolled intercurrent illness.
Concurrent or Intercurrent Illness:
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Concurrent severe, intercurrent illness.
Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product
Uncontrolled current illness
Subject has uncontrolled intercurrent illness including, but not limited to:
Other uncontrolled significant illness.
No exclusion requirements due to co-morbid disease or intercurrent illness
Uncontrolled serious concurrent illness
Serious intercurrent medical illness
Uncontrolled intercurrent illness including, but not limited to active infections
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
No requirements due to co-morbid disease or intercurrent illness, as needed
Uncontrolled intercurrent illness.
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol
Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infection
Patients with known serious concurrent infection or medical illness, including psychiatric disorders
Patients with an active infection or serious intercurrent medical illness
Patients with an active infection or serious intercurrent medical illness are ineligible
Has a serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism).
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol
Patients with an active infection or serious intercurrent medical illness are ineligible
Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen
Serious concurrent illness, including clinically relevant active infection
Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 14 days prior to randomization
Patients must not have active infection or serious intercurrent medical illness.
Intercurrent illness that would substantially increase the risk of treatment associated complications (e.g., active infection, uncontrolled diabetes mellitus or hypertension) and/or psychiatric illness/social situations that would interfere with the patient's ability to comply with the treatment regimen
Clinically significant unrelated systemic illness (including but not limited to active life threatening infection, cardiac or neurologic events, current hospital admission for a coexisting comorbid illness), which would make it impossible for the patient to tolerate re-irradiation or systemic chemotherapy or likely to interfere with the results
Any active infection or infectious illness unless fully recovered prior to dosing.
Uncontrolled intercurrent illness including, but not limited to, active infection, poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study
Patients has an active infection or serious intercurrent medical illness
Serious concurrent illness, including clinically relevant active infection
Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders.
Have any serious or unstable concomitant systemic conditions that are incompatible with this clinical study, including but not limited to substance abuse, psychiatric disturbance, or uncontrolled intercurrent illness (including active infection), arterial thrombosis, or symptomatic pulmonary embolism
Serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
Any uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness
Serious intercurrent medical or psychiatric illness including serious active infection
Serious concurrent illness or clinically relevant active infection as defined in the protocol
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol
History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
Serious intercurrent medical or psychiatric illness, including serious active infection
Serious intercurrent medical or psychiatric illness that will prevent participation or compliance with study procedures, including serious active infection
have a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection, including chronic viral hepatitis
Serious intercurrent medical or psychiatric illness, including serious active infection
Patients with a serious unstable medical illness or another active cancer
Serious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosis
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
Serious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosis
No significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active gastrointestinal (GI) bleeding
Patients must NOT have active or uncontrolled infection or serious medical or psychiatric illness
Serious intercurrent medical or psychiatric illness, including serious active infection
Active infection or intercurrent illness
Patients must not have active infection or serious intercurrent medical illness
Significant active concurrent medical illness or infection precluding protocol treatment or survival
The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
Another concurrent illness which would preclude study conduct and assessment, uncontrolled: medical condition, active infection, risk of bleeding, diabetes mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary cirrhosis.
Any serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not to limited, any the following:\r\n* History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychiatric disorders) that would impair the ability to obtain consent or limit compliance with study requirement\r\n* Active uncontrolled or serious infection\r\n* Active peptic ulcer disease
They should have no significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active gastrointestinal (GI) bleeding
Patients with: a) active infection, b) disease that will obscure toxicity or dangerously alter drug metabolism, c) serious intercurrent medical illness, d) prior documented recurrence with temozolomide
Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse; uncontrolled intercurrent illness including active infection; arterial thrombosis; unstable respiratory, hepatic, renal or cardiac disease; and other active malignancy)
Patients with a serious unstable medical illness or another active cancer
Patients who have active or uncontrolled infection or serious medical or psychiatric illness preventing informed consent or on intensive treatment
Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection
Serious concurrent illness or clinically relevant active infection, including known diagnosis of HIV and hepatitis B or C, as defined in the protocol
Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 2 weeks before Segment B enrollment