Trial Outcomes & Findings for Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer (NCT NCT01101334)

Last Updated: 2020-06-16

Results Overview

Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Baseline to disease progression or death, up to approximately 2.5 years

Results posted on

2020-06-16

Participant Flow

A total of 90 participants who met all inclusion and no exclusion criteria were randomized to treatment; 89 participants received treatment.

Participant milestones

Participant milestones
Measure	CS-7017 Plus Erlotinib Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib Participants who received one 150 mg erlotinib tablet administered once daily.
Overall Study STARTED	45	45
Overall Study Received Study Treatment	44	45
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	45	45

Reasons for withdrawal

Reasons for withdrawal
Measure	CS-7017 Plus Erlotinib Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib Participants who received one 150 mg erlotinib tablet administered once daily.
Overall Study Adverse Event	9	4
Overall Study Death	7	1
Overall Study Withdrawal by Subject	4	3
Overall Study Withdrawal by Sponsor	1	1
Overall Study Progressive Disease	22	35
Overall Study Other	2	1

Baseline Characteristics

Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CS-7017 Plus Erlotinib n=44 Participants Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib n=45 Participants Participants who received one 150 mg erlotinib tablet administered once daily.	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=99 Participants	31 Participants n=107 Participants	64 Participants n=206 Participants
Age, Categorical >=65 years	11 Participants n=99 Participants	14 Participants n=107 Participants	25 Participants n=206 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 10.36 • n=99 Participants	61.4 years STANDARD_DEVIATION 11.34 • n=107 Participants	60.5 years STANDARD_DEVIATION 10.85 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	20 Participants n=107 Participants	31 Participants n=206 Participants
Sex: Female, Male Male	33 Participants n=99 Participants	25 Participants n=107 Participants	58 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to disease progression or death, up to approximately 2.5 years

Population: PFS was assessed in the Full Analysis Set.

Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	CS-7017 Plus Erlotinib n=44 Participants Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib n=45 Participants Participants who received one 150 mg erlotinib tablet administered once daily.
Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	4.1 months Interval 2.7 to 6.7	3.0 months Interval 2.2 to 5.3

SECONDARY outcome

Timeframe: Baseline to death, up to approximately 2.5 years

Population: OS was assessed in the Full Analysis Set.

Overall survival (OS) was defined as the time from randomization until death from any cause.

Outcome measures

Outcome measures
Measure	CS-7017 Plus Erlotinib n=44 Participants Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib n=45 Participants Participants who received one 150 mg erlotinib tablet administered once daily.
Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	7.6 months Interval 3.8 to 12.0	11.4 months Interval 9.7 to 15.0

SECONDARY outcome

Timeframe: Baseline to disease progression or death, up to approximately 2.5 years

Population: ORR was assessed in the Full Analysis Set.

The overall response rate (ORR) was defined as the proportion of participants who achieved best overall response of complete response (CR) or partial response (PR); ORR = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	CS-7017 Plus Erlotinib n=44 Participants Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib n=45 Participants Participants who received one 150 mg erlotinib tablet administered once daily.
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	9 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline to 30 days after last dose, up to approximately 2.5 years

Population: TEAEs were assessed in the Safety Analysis Set.

A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state.

Outcome measures

Outcome measures
Measure	CS-7017 Plus Erlotinib n=44 Participants Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib n=45 Participants Participants who received one 150 mg erlotinib tablet administered once daily.
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Any TEAE	44 Participants	43 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Blood and Lymphatic System Disorders	18 Participants	4 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Anaemia	16 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Cardiac Disorders	7 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Eye Disorders	8 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Gastrointestinal Disorders	27 Participants	25 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Constipation	10 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Diarrhea	18 Participants	19 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Nausea	5 Participants	7 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Stomatitis	6 Participants	6 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy General Disorders & Administration Site Conditions	41 Participants	19 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Asthenia	9 Participants	8 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Disease progression	8 Participants	5 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Face edema	10 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Fatigue	9 Participants	5 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Noncardiac chest pain	5 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Edema peripheral	17 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Pyrexia	9 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Infections and Infestations	13 Participants	16 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Investigations	15 Participants	12 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Weight increased	7 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Metabolism and Nutrition Disorders	27 Participants	15 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Decreased appetite	18 Participants	10 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Hypokalemia	7 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Musculoskeletal and Connective Tissue Disorders	15 Participants	10 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Pain in extremity	7 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Nervous System Disorders	15 Participants	6 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Dizziness	5 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Headache	5 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Psychiatric Disorders	6 Participants	5 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Respiratory, Thoracic, and Mediastinal Disoders	25 Participants	17 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Cough	5 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Dyspnea	9 Participants	7 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Pleural effusion	10 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Skin and Subcutaneous Tissue Disorders	33 Participants	30 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Alopecia	5 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Dermatitis acneiform	15 Participants	9 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Dry skin	5 Participants	7 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Pruritus	9 Participants	11 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Rash	11 Participants	15 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Swelling face	5 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy Vascular Disorders	1 Participants	5 Participants

Adverse Events

CS-7017 Plus Erlotinib

Serious events: 24 serious events

Other events: 44 other events

Deaths: 15 deaths

Erlotinib

Serious events: 16 serious events

Other events: 43 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CS-7017 Plus Erlotinib n=44 participants at risk Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.	Erlotinib n=45 participants at risk Participants who received one 150 mg erlotinib tablet administered once daily.
Blood and lymphatic system disorders Anaemia	36.4% 16/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	6.7% 3/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
General disorders Death	9.1% 4/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	2.2% 1/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
General disorders Disease progression	18.2% 8/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	11.1% 5/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
General disorders Fatigue	20.5% 9/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	11.1% 5/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Investigations Neutrophil count decreased	6.8% 3/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	0.00% 0/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Blood and lymphatic system disorders Any Blood and Lymphatic System Disorders	40.9% 18/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	8.9% 4/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Cardiac disorders Any Cardiac Disorders	15.9% 7/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	4.4% 2/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
General disorders Any General Disorders & Administration Site Conditions	93.2% 41/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	42.2% 19/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Investigations Any Investigations	34.1% 15/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	26.7% 12/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Any Neoplasms Benign, Malignant, and Unspecified (Including Cysts and Polyps)	9.1% 4/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	4.4% 2/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Respiratory, thoracic and mediastinal disorders Any Respiratory, Thoracic, and Mediastinal Disorders	56.8% 25/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	37.8% 17/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.
Skin and subcutaneous tissue disorders Any Skin and Subcutaneous Tissue Conditions	75.0% 33/44 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.	66.7% 30/45 • Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years. A TEAE was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. All-cause mortality includes all deaths caused by TEAEs.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place