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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .
This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A; tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B; MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled concurrently into multiple cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib with a Seq. Switch to a MEDI4736 | Experimental | Gefitinib once daily followed by MEDI4736 |
|
| AZD9291 with a Seq. Switch to a MEDI4736 | Experimental | AZD9291 once daily followed by MEDI4736 |
|
| Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736 | Experimental | Selumetinib twice daily + docetaxel, followed by MEDI4736 |
|
| Tremelimumab with a Seq. Switch to a MEDI4736 | Experimental | Tremelimumab every 4 weeks followed by MEDI4736 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | Gefitinib once daily followed by MEDI4736 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Complete Response (CR) Rate | To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | To further assess the efficacy of various sequences. Objective response rate (ORR; per RECIST 1.1 as assessed by the site Investigator) is defined as the number (%) of patients with a confirmed overall response of CR or PR and was based on the evaluable analysis set. Per 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; Overall Response (OR) = CR + PR. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir N. Khleif, MD | International Coordinating Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Goodyear | Arizona | 85338 | United States | ||
| Research Site |
Due to the small numbers of patients treated in Cohorts A through C (gefitinib, AZD9291, or selumetinib + docetaxel), statistical analyses were only done and summary tables prepared for the 28 patients randomised to Cohort D (tremelimumab, either 1-cycle or 2-cycles).
This study was conducted at 10 study centers in United States. The first subject was enrolled on 25 July 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefitinib With a Seq. Switch to a MEDI4736 | Gefitinib once daily followed by MEDI4736 - analyses not done due to low n |
| FG001 | AZD9291 With a Seq. Switch to a MEDI4736 | The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AZD9291 |
| Drug |
AZD9291 once daily followed by MEDI4736 |
|
| Selumetinib+Docetaxel | Drug | Selumetinib twice daily + docetaxel, followed by MEDI4736 |
|
| Tremelimumab | Drug | Tremelimumab every 4 weeks followed by MEDI4736 |
|
| Up to 2 years |
| Progression-free Survival | Progression-free survival (per RECIST 1.1 as assessed by Investigator) is defined as the date of 1st dose of MEDI4736 until the date of objective disease progression or death. Progression of disease (PD) At least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Up to 2 years |
| Duration of Response | Duration of response (DoR; per RECIST 1.1 as assessed by the site Investigator) will be defined as the time from the date of 1st documented response (which is subsequently confirmed) until the 1st date of documented progression or death in the absence of disease progression. | Within 12 months |
| Overall Survival | To assess the efficacy of various sequences. In survival follow up at data cut off. | Up to 2 years |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Research Site | Augusta | Georgia | 30912 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Ashland | Kentucky | 41101 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Mineola | New York | 11501 | United States |
| Research Site | Huntersville | North Carolina | 28078 | United States |
| Research Site | Spokane | Washington | 99208-1129 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| FG002 | Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736 | Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n |
| FG003 | Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736 | Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736 |
| FG004 | Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 | Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736 |
| COMPLETED |
|
| NOT COMPLETED |
|
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database. Because the AZD9291 with a Seq. Switch to a MEDI4736 arm had no data recorded during the study, this arm is not included in the reporting of adverse events.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefitinib With a Seq. Switch to a MEDI4736 | Gefitinib once daily followed by MEDI4736 - analyses not done due to low n |
| BG001 | Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736 | Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n |
| BG002 | Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736 | Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736 |
| BG003 | Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 | TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS |
| BG004 | AZD9291 With a Seq. Switch to a MEDI4736 | The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | Confirmed Complete Response (CR) Rate | To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set. | Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. | Posted | Number | 80% Confidence Interval | patients (%) | Up to 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | To further assess the efficacy of various sequences. Objective response rate (ORR; per RECIST 1.1 as assessed by the site Investigator) is defined as the number (%) of patients with a confirmed overall response of CR or PR and was based on the evaluable analysis set. Per 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; Overall Response (OR) = CR + PR. | Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. | Posted | Number | 80% Confidence Interval | patients (%) | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival (per RECIST 1.1 as assessed by Investigator) is defined as the date of 1st dose of MEDI4736 until the date of objective disease progression or death. Progression of disease (PD) At least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. | Posted | Number | patients | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response (DoR; per RECIST 1.1 as assessed by the site Investigator) will be defined as the time from the date of 1st documented response (which is subsequently confirmed) until the 1st date of documented progression or death in the absence of disease progression. | Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. Response was observed for 1 patient in the Tremelimumab 1-cycle arm for up to and including 6 months. | Posted | Median | Inter-Quartile Range | Months | Within 12 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | To assess the efficacy of various sequences. In survival follow up at data cut off. | Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. | Posted | Number | patients | Up to 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gefitinib With a Seq. Switch to a MEDI4736 | Gefitinib once daily followed by MEDI4736 - analyses not done due to low n | 0 | 1 | 1 | 1 | ||
| EG001 | Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736 | Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n | 1 | 2 | 2 | 2 | ||
| EG002 | AZD9291 With a Seq. Switch to MEDI4736 | The 1 patient in the AZD9291 cohort was not dosed and no data were recorded in the database. | 0 | 0 | 0 | 0 | ||
| EG003 | Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736 | Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736 | 5 | 14 | 13 | 14 | ||
| EG004 | Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 | TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS | 8 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mitral valve stenosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Dennis | AstraZeneca | 1 + 301-398-5549 | Phillip.Dennis@astrazeneca.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| C000596361 | osimertinib |
| C520704 | tremelimumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| OG003 | Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736 | Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736 |
| OG004 | Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 | Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736 |
|
|
| OG003 | Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736 | Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736 |
| OG004 | Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 | Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736 |
|
|
| Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736 |
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736 |
| OG004 | Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 | Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736 |
|
|
| OG004 |
| Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736 |
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736 |
|
|