Trial · NCT01101334

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

NCT01101334, Phase 2, Completed, Daiichi Sankyo; results first posted 2020-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer. Trials, record NCT01101334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01101334

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
NCT number: NCT01101334
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Daiichi Sankyo
Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)
Interventions: CS-7017, erlotinib
First posted: 2010-04-09
Last updated: 2020-06-16
Results first posted: 2020-06-16

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Baseline to disease progression or death, up to approximately 2.5 years	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.
Secondary	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	Baseline to death, up to approximately 2.5 years	Overall survival (OS) was defined as the time from randomization until death from any cause.
Secondary	Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Baseline to disease progression or death, up to approximately 2.5 years	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.
Secondary	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	Baseline to 30 days after last dose, up to approximately 2.5 years	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	Baseline to disease progression or death, up to approximately 2.5 years	PFS was assessed in the Full Analysis Set.	months	MEDIAN
SECONDARY	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	Baseline to death, up to approximately 2.5 years	OS was assessed in the Full Analysis Set.	months	MEDIAN
SECONDARY	Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Baseline to disease progression or death, up to approximately 2.5 years	ORR was assessed in the Full Analysis Set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	Baseline to 30 days after last dose, up to approximately 2.5 years	TEAEs were assessed in the Safety Analysis Set.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group90

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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	CS-7017 Plus Erlotinib		4.1	95% Confidence Interval 2.7 to 6.7	months
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	Erlotinib		3.0	95% Confidence Interval 2.2 to 5.3	months
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	CS-7017 Plus Erlotinib		7.6	95% Confidence Interval 3.8 to 12.0	months
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	Erlotinib		11.4	95% Confidence Interval 9.7 to 15.0	months
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	CS-7017 Plus Erlotinib		9		Participants
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Erlotinib		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	CS-7017 Plus Erlotinib	Any TEAE	44		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	Erlotinib	Any TEAE	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	CS-7017 Plus Erlotinib	Blood and Lymphatic System Disorders	18		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	Erlotinib	Blood and Lymphatic System Disorders	4		Participants

1 to 10 of 90Source ClinicalTrials.gov

See all 90 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CS-7017 Plus Erlotinib	45
Overall Study	STARTED	Erlotinib	45
Overall Study	Received Study Treatment	CS-7017 Plus Erlotinib	44
Overall Study	Received Study Treatment	Erlotinib	45
Overall Study	COMPLETED	CS-7017 Plus Erlotinib	0
Overall Study	COMPLETED	Erlotinib	0
Overall Study	NOT COMPLETED	CS-7017 Plus Erlotinib	45
Overall Study	NOT COMPLETED	Erlotinib	45

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	CS-7017 Plus Erlotinib	16	44
other	Anaemia	Blood and lymphatic system disorders	Erlotinib	3	45
other	Death	General disorders	CS-7017 Plus Erlotinib	4	44
other	Death	General disorders	Erlotinib	1	45
other	Disease progression	General disorders	CS-7017 Plus Erlotinib	8	44
other	Disease progression	General disorders	Erlotinib	5	45
other	Fatigue	General disorders	CS-7017 Plus Erlotinib	9	44
other	Fatigue	General disorders	Erlotinib	5	45
other	Neutrophil count decreased	Investigations	CS-7017 Plus Erlotinib	3	44
other	Neutrophil count decreased	Investigations	Erlotinib	0	45

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CS-7017 Plus Erlotinib	15	44
Total, all-cause mortality	Erlotinib	7	45
Total, other adverse events	CS-7017 Plus Erlotinib	44	44
Total, other adverse events	Erlotinib	43	45
Total, serious adverse events	CS-7017 Plus Erlotinib	24	44
Total, serious adverse events	Erlotinib	16	45

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CS-7017 Plus Erlotinib vs Erlotinib: Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Trial comparisons
CS-7017 Plus Erlotinib vs Erlotinib: deaths from any cause	Trial comparisons
CS-7017 Plus Erlotinib vs Erlotinib: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01101334

GET https://conductscience.org/api/trials/v1/NCT01101334/results?page=2

API reference For AI assistants