Trial · NCT01529112

A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments

NCT01529112, Phase 2, Completed, Eisai Inc.; results first posted 2016-02-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments. Trials, record NCT01529112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01529112

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Trial

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

Title: A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments
NCT number: NCT01529112
Status: Completed
Phases: Phase 2
Enrollment: 135 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Non-Small Cell Lung Cancer
Interventions: Lenvatinib, Lenvatinib matched placebo, BSC
First posted: 2012-02-08
Last updated: 2017-09-26
Results first posted: 2016-02-18

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months	OS was defined as the time from the date of randomization until the date of death from any cause.
Secondary	Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)	For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)	An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the subject was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, treatment emergent adverse events (TEAEs) (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Secondary	6-Month Survival Rate	From date of randomization (Day 1) up to 6 months	Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 6 months and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.
Secondary	1-year Survival Rate	From date of randomization (Day 1) up to 1 year	Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 1 year and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.
Secondary	Progression-Free Survival (PFS)	From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)	PFS was defined as the time from the date of the randomization until the date of first documented disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or date of death from any cause (whichever occurred first), assessed based on investigator's assessment. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Secondary	Overall Response Rate (ORR)	From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)	ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Secondary	Response Duration (RD)	From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)	Response duration, defined as the time from the date of the first assessment demonstrating a CR or PR to the date of the first assessment demonstrating progressive disease or death, whichever occurred first. This is an investigator assessed outcome, measured using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response duration was summarized by including only subjects with events. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Secondary	Disease Control Rate (DCR)	From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)	The percentage of participants with CR, PR, or stable disease (SD) for greater than or equal to 12 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Secondary	The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)	Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)	The EORTC QLQ-C30 symptom score, a cancer specific self-reporting questionnaire was composed of 9-symptom scales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All of the multi-item scales and single-item measures ranged in score from 0 to 100. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with a higher scale score representing a higher response level/ high level of symptomatology / problems. The data is presented as percentage of participants with EORTC QLQ-C30 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Secondary	The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL	Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)	The EORTC module QLQ-LC13 symptom score was a self-reporting cancer-specific questionnaire composed of 13 questions incorporated into 1 multi-item scale designed to evaluate dyspnea and a series of single items assessing different types of pain, as well as, cough, hemoptysis, dysphagia, sore mouth, alopecia, and peripheral neuropathy. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with 100 representing the best possible function/QOL, and highest burden of symptoms for symptom domains and single items. The data is presented as percentage of participants with EORTC module QLQ-C13 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)	For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)	Safety was analyzed in Safety Analysis Set defined as all subjects enrolled and randomized to treatment in study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.	Participants	NUMBER
SECONDARY	6-Month Survival Rate	From date of randomization (Day 1) up to 6 months	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	Percentage of Participants	NUMBER
SECONDARY	1-year Survival Rate	From date of randomization (Day 1) up to 1 year	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	Percentage of Participants	NUMBER
SECONDARY	Progression-Free Survival (PFS)	From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	weeks	MEDIAN
SECONDARY	Overall Response Rate (ORR)	From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	Percentage of Participants	NUMBER
PRIMARY	Overall Survival (OS)	From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	weeks	MEDIAN
SECONDARY	Response Duration (RD)	From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)	The analysis was performed using subjects with events.	Weeks	MEDIAN
SECONDARY	Disease Control Rate (DCR)	From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	Percentage of Participants	NUMBER
SECONDARY	The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)	Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	Percentage of participants	NUMBER
SECONDARY	The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL	Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)	The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.	Percentage of participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group73

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)	Lenvatinib	Treatment Emergent Non-Serious AEs	83		Participants
Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)	Lenvatinib Matched Placebo	Treatment Emergent Non-Serious AEs	42		Participants
Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)	Lenvatinib	Treatment Emergent SAEs	46		Participants
Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)	Lenvatinib Matched Placebo	Treatment Emergent SAEs	21		Participants
6-Month Survival Rate	Lenvatinib		61.6	95% Confidence Interval 50.24 to 71.1	Percentage of Participants
6-Month Survival Rate	Lenvatinib Matched Placebo		49	95% Confidence Interval 33.49 to 62.8	Percentage of Participants
1-year Survival Rate	Lenvatinib		35.8	95% Confidence Interval 25.13 to 46.54	Percentage of Participants
1-year Survival Rate	Lenvatinib Matched Placebo		20.5	95% Confidence Interval 9.96 to 33.74	Percentage of Participants
Progression-Free Survival (PFS)	Lenvatinib		20.9	95% Confidence Interval 15.86 to 23.86	weeks
Progression-Free Survival (PFS)	Lenvatinib Matched Placebo		7.9	95% Confidence Interval 7.43 to 8.14	weeks

1 to 10 of 73Source ClinicalTrials.gov

See all 73 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lenvatinib	89
Overall Study	STARTED	Lenvatinib Matched Placebo	46
Overall Study	COMPLETED	Lenvatinib	20
Overall Study	COMPLETED	Lenvatinib Matched Placebo	5
Overall Study	NOT COMPLETED	Lenvatinib	69
Overall Study	NOT COMPLETED	Lenvatinib Matched Placebo	41

Source ClinicalTrials.gov

Adverse events206

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	Lenvatinib	1	89
other	ANAEMIA	Blood and lymphatic system disorders	Lenvatinib Matched Placebo	3	46
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Lenvatinib	5	89
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Lenvatinib Matched Placebo	0	46
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Lenvatinib	1	89
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Lenvatinib Matched Placebo	3	46
other	ABDOMINAL PAIN	Gastrointestinal disorders	Lenvatinib	15	89
other	ABDOMINAL PAIN	Gastrointestinal disorders	Lenvatinib Matched Placebo	1	46
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Lenvatinib	5	89
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Lenvatinib Matched Placebo	1	46

1 to 10 of 206Source ClinicalTrials.gov

See all 206 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lenvatinib
Total, all-cause mortality	Lenvatinib Matched Placebo
Total, other adverse events	Lenvatinib	83	89
Total, other adverse events	Lenvatinib Matched Placebo	42	46
Total, serious adverse events	Lenvatinib	46	89
Total, serious adverse events	Lenvatinib Matched Placebo	21	46

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 comparisons1

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

Comparison
Lenvatinib vs Lenvatinib Matched Placebo: serious adverse events

Source 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.

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Read this trial from software.

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