Targeted Therapy in Treating Patients With Incurable Non-... | NCT02949843

ID	Type	Description	Link
NCI-2016-01589	Registry Identifier	CTRP (Clinical Trial Reporting Program)
CCCWFU 62716	Other Identifier	Comprehensive Cancer Center of Wake Forest University
P30CA012197	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the objective response rate among patients with high PD-L1 expressing cancers after failure of targeted therapy.

SECONDARY OBJECTIVES:

I. To compare the overall survival for patients receiving treatment targeting primary mutations, secondary mutations, or immunotherapy at the time of progression on tyrosine kinase inhibitor therapy.

II. To assess the incidence of secondary mutations in this population according to smoking status.

III. To evaluate the response rates of patients treated using these different approaches.

IV. To correlate outcomes with specific secondary genetic changes.

OUTLINE: Patients are assigned to 1 of 3 treatment arms.

ARM I (PD-L1 >= 50%): Patients receive nivolumab intravenously (IV) over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.

ARM II (PD-L1 < 50% without secondary oncogenic driver): Patients receive tyrosine kinase inhibitor therapy orally (PO) targeting the initial oncogenic driver or other treatment for about 3 weeks.

ARM III (PD-L1 < 50% with secondary oncogenic driver): Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks.

After completion of study treatment, patients are followed up for a minimum of 30 days.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm I (nivolumab, pembrolizumab)	Experimental	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Biological: Nivolumab Biological: Pembrolizumab
Arm II (kinase inhibitor, chemotherapy, immunotherapy)	Experimental	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks.	Drug: Chemotherapy Biological: Immunotherapy Other: Laboratory Biomarker Analysis Drug: Tyrosine Kinase Inhibitor
Arm III (kinase inhibitor, targeted therapy, other treatment)	Experimental	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks.	Drug: Chemotherapy Biological: Immunotherapy Other: Laboratory Biomarker Analysis Drug: Targeted Molecular Therapy Drug: Tyrosine Kinase Inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy	Drug	Receive other treatment	Arm II (kinase inhibitor, chemotherapy, immunotherapy) Arm III (kinase inhibitor, targeted therapy, other treatment)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate in Patients With High PD-L1 Expressing Cancers After Failure of Targeted Therapy Defined as Complete or Partial Response According to the Investigator's Assessment	Objective Response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). This outcome applies only to Arm I. * Complete Response (CR): Disappearance of all target lesions, * Partial Response (PR): At least a 30% decrease in the sum of the target lesions Progressive Disease (PD): At least a 20% increase in the sum of the target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease	Up to 1 year after failure of targeted therapy

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events Measured Using Common Terminology Criteria for Adverse Events Version 4.0	Toxicities for each group will be estimated and described using counts and frequencies by grade, location and relatedness.	Adverse events were collected following each cycle of treatment (1-4) and up to 30 days after the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks.

Eligibility Module

Name	Affiliation	Role
William Petty	Wake Forest University Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Cancer Center of Wake Forest University		Winston-Salem	North Carolina	27157	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 17, 2018

Arm/Group Information

ID	Title	Description
BG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
BG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO
BG002	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0001 BG0012 BG0023 BG0036

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

Objective Response Rate in Patients With High PD-L1 Expressing Cancers After Failure of Targeted Therapy Defined as Complete or Partial Response According to the Investigator's Assessment

Objective Response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). This outcome applies only to Arm I. * Complete Response (CR): Disappearance of all target lesions, * Partial Response (PR): At least a 30% decrease in the sum of the target lesions Progressive Disease (PD): At least a 20% increase in the sum of the target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease

This outcome applies only to Arm I.

Posted

Count of Participants

Participants

Up to 1 year after failure of targeted therapy

ID	Title	Description
OG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
OG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO
OG002	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO

Units	Counts
Participants	OG0001 OG0010 OG0020

Title

Denominators

Categories

Title	Measurements
Partial Response	OG0001 OG0010 OG0020
Stable Disease

Secondary

Number of Participants With Adverse Events Measured Using Common Terminology Criteria for Adverse Events Version 4.0

Toxicities for each group will be estimated and described using counts and frequencies by grade, location and relatedness.

One patient in Arm II refused additional treatment and was not evaluated for adverse events, although this patient was followed for survival.

Posted

Count of Participants

Participants

Adverse events were collected following each cycle of treatment (1-4) and up to 30 days after the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks.

ID	Title	Description
OG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
OG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO
OG002

Secondary

Number of Mutations in Secondary Genes for Patients With PD-L1 Expression < 50%

This outcome applies to only Arms II and III.

This outcome applies only to Arms II and III; secondary gene mutation testing was not done in Arm I.

Posted

Count of Participants

Participants

Up to 1 year after failure of targeted therapy

ID	Title	Description
OG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
OG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO
OG002	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO

Secondary

Objective Response Rates for Patients Without High PD-L1 Expressing Cancers

Objective response rates will be estimated in the two PD-L1 expression < 50% arms. At the time of protocol development, the intention was to estimate confidence intervals for each of these rates, and to make an exploratory comparison among the three groups comparing complete response/partial response versus stable disease/progressive disease among the groups using a Fisher's exact test (for the 2x3 table). Due to the low numbers of patients evaluable for response, these analyses were not performed.

One patient in Arm II refused additional treatment and is not evaluable for response; one patient in Arm III expired one month after starting secondary treatment and is not evaluable for response.

Posted

Count of Participants

Participants

Up to 3 years after failure of targeted therapy

ID	Title	Description
OG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
OG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO

Secondary

Overall Survival

Estimated using Kaplan-Meier methods and survival rates will be compared using log-rank tests.

Note: Log-rank tests will not be used due to the very low sample size.

Patient records were reviewed at this time for all six patients.

Posted

Median

Full Range

months

From date of progression on primary targeted treatment to death, assessed up to 3 years.

ID	Title	Description
OG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
OG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO
OG002	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO

Secondary

Rate of Tobacco Use and Mutation Burden Based on PD-L1 Expression at Time of Progression

Smoking History was defined as Never, Former or Current

Posted

Count of Participants

Participants

Assessed at enrollment into study.

ID	Title	Description
OG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV
OG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO
OG002	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm I (Nivolumab, Pembrolizumab)	Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	0	1	0	1	1	1
EG001	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)	Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	2	2	1	1	1	1
EG002	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)	Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO	2	3	2	3	3	3

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0024 events2 affected3 at risk
Leukocytotsis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected1 at risk EG0010 events0 affected1 at risk EG0023 events1 affected3 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0024 events2 affected3 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Hemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Fever	General disorders	Systematic Assessment	EG0003 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Fatigue	General disorders	Systematic Assessment	EG0002 events1 affected1 at risk EG0010 events0 affected1 at risk EG0023 events2 affected3 at risk
Pain	General disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0022 events1 affected3 at risk
Lung Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Creatinine increased	Investigations	Systematic Assessment	EG0004 events1 affected1 at risk EG0010 events0 affected1 at risk EG0025 events3 affected3 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0023 events2 affected3 at risk
CD4 lymphocytes decreased	Investigations	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0020 events0 affected3 at risk
Hypercalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Hypernatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events1 affected1 at risk EG0011 events1 affected1 at risk EG0024 events2 affected3 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events1 affected1 at risk EG0011 events1 affected1 at risk EG0025 events3 affected3 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events1 affected1 at risk EG0011 events1 affected1 at risk EG0024 events2 affected3 at risk
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0023 events3 affected3 at risk
Hypermagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0023 events3 affected3 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0022 events2 affected3 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D004358	Drug Therapy
D007167	Immunotherapy
D000276	Adjuvants, Immunologic
D000077594	Nivolumab
C582435	pembrolizumab
D058990	Molecular Targeted Therapy
D000092004	Tyrosine Kinase Inhibitors

ID	Term
D013812	Therapeutics
D056747	Immunomodulation
D001691	Biological Therapy
D007155	Immunologic Factors
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D047428	Protein Kinase Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action