A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (JUNIPER)

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ClinicalTrials.gov Identifier: NCT02152631

Recruitment Status : Active, not recruiting

First Posted : June 2, 2014

Results First Posted : December 12, 2018

Last Update Posted : April 18, 2024

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Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Non Small Cell Lung Cancer
Interventions	Drug: Abemaciclib Drug: Erlotinib
Enrollment	453

Participant Flow

Recruitment Details
Pre-assignment Details	Completers are defined as those participants who had progressive disease, death due to any cause or alive and on study at the end of study, but off treatment.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description	200 milligrams (mg) abemaciclib adm...	150 mg erlotinib administered, oral...
Arm/Group Description	200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Period Title: Overall Study
Started	270	183
Received at Least One Dose of Study Drug	265	175
Off Treatment	246	172
Death Due to Any Cause	30	20
Progressive Disease	174	137
Completed	204	157
Not Completed	66	26
Reason Not Completed
Adverse Event	32	4
Withdrawal by Subject	13	16
Noncompliance with study drug	1	0
Physician Decision	1	2
Lost to Follow-up	0	1
On Treatment	19	3

Baseline Characteristics

Arm/Group Title		Abemaciclib	Erlotinib	Total
Arm/Group Description		200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...	Total of all reporting groups
Arm/Group Description		200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).	Total of all reporting groups
Overall Number of Baseline Participants		270	183	453
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	270 participants	183 participants	453 participants
		62.3 (8.9)	62.9 (8.4)	62.5 (8.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	270 participants	183 participants	453 participants
	Female	107	74	181
	Male	163	109	272
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	270 participants	183 participants	453 participants
	Hispanic or Latino	13	12	25
	Not Hispanic or Latino	197	132	329
	Unknown or Not Reported	60	39	99
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	270 participants	183 participants	453 participants
	American Indian or Alaska Native	0	1	1
	Asian	56	41	97
	Native Hawaiian or Other Pacific Islander	0	0	0
	Black or African American	1	2	3
	White	165	106	271
	More than one race	3	1	4
	Unknown or Not Reported	45	32	77
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	270 participants	183 participants	453 participants
Argentina		1	2	3
Romania		7	7	14
United States		44	30	74
Japan		22	17	39
Ukraine		6	5	11
Russia		8	4	12
Spain		26	13	39
Greece		1	6	7
Canada		4	4	8
Austria		0	2	2
South Korea		13	13	26
Turkey		21	8	29
China		7	4	11
Taiwan		12	7	19
Brazil		7	5	12
Poland		6	2	8
Italy		5	12	17
Israel		5	1	6
France		35	32	67
Germany		30	14	44

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	OS defined as from randomization date to the date of death due to any ...
Description	OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Time Frame	From Randomization Date to Date of Death from Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants. 81 participants were censored in the Abemaciclib arm and 56 participants were censored in the Erlotinib arm.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description:	200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	270	183
Median (95% Confidence Interval) Unit of Measure: months
	7.4 (6.5 to 8.8)	7.8 (6.4 to 9.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS [G12C] vs. all others)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.771
	Comments	[Not Specified]
	Method	Stratified Log-Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.968
	Confidence Interval	(2-Sided) 95% 0.768 to 1.219
	Estimation Comments	Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.

2.Secondary Outcome


Title	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Description	ORR was the percentage of participants achieving a best overall respon...
Description	ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Time Frame	From Randomization Date to Objective Progression (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description:	200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	270	183
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	8.9 (5.5 to 12.3)	2.7 (0.4 to 5.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS [G12C] vs. all others)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.010
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

3.Secondary Outcome


Title	Progression Free Survival (PFS)
Description	PFS defined as the from randomization date to the first evidence of di...
Description	PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Time Frame	From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants. 36 participants were censored in the abemaciclib arm and 24 were censored in the erlotinib arm.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description:	200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	270	183
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: months
	3.6 (2.8 to 3.8)	1.9 (1.9 to 2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	Stratified Log-Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.583
	Confidence Interval	(2-Sided) 95% 0.470 to 0.723
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score
Description	The MDASI-LC included 22 items + 3 additional trial-specific items, re...
Description	The MDASI-LC included 22 items + 3 additional trial-specific items, resulting in 6 collected and reported single-construct scores including core symptoms (13-item), interference (6-item), lung cancer (3-item), and trial-specific single outcomes for headache, diarrhea, and rash. A 2-construct composite core + lung cancer symptom (16-item) score was calculated. Data for all 7 scores were collected by an 11-point numeric rating scale anchored at 0 (not present or does not interfere) and 10 (as bad as you can imagine or interfered completely). The measurement range was 10 (maximum score-minimum score). Mixed Model Repeated Measure (MMRM) regression with covariates for treatment, visit, treatment*visit, and baseline score predicted between-group Least Squares (LS) mean differences from baseline. Group-level negative change from baseline indicated group improvement.
Time Frame	From Randomization Date through End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants for cycles which at least 25% of participants in each arm have a score. MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC result.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description:	200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	270	183
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
Headache	0.20 (0.11)	0.27 (0.15)
Diarrhea	1.91 (0.17)	1.32 (0.23)
Rash	0.65 (0.17)	3.05 (0.22)
Mean Core Symptom Severity	0.49 (0.10)	0.73 (0.13)
Mean Interference	0.70 (0.14)	0.85 (0.18)
Mean Lung Cancer Symptom Severity	0.16 (0.09)	0.23 (0.12)
Mean Core Plus Lung Cancer Symptom Severity	0.44 (0.09)	0.65 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Headache
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.698
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95% -0.44 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Diarrhea
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.038
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95% 0.03 to 1.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Rash
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-2.40
	Confidence Interval	(2-Sided) 95% -2.94 to -1.86
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Mean Core Symptom Severity
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.142
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95% -0.56 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.16
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Mean Interference
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.514
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95% -0.59 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.23
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Mean Lung Cancer
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.646
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95% -0.37 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	Mean Core Plus Lung Cancer
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.188
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95% -0.51 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.15
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State
Description	PK is determined by the area under the plasma concentration versus tim...
Description	PK is determined by the area under the plasma concentration versus time curve during 1 dosing interval at steady state
Time Frame	Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles)

Outcome Measure Data

Analysis Population Description

All randomized participants who received Abemaciclib and had evaluable PK data.


Arm/Group Title	Abemaciclib
Arm/Group Description:	200 mg abemaciclib administered, or...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	265
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: Hournanogram/milliliter (hng/mL)
	3350 (52%)

6.Secondary Outcome


Title	Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score
Description	There are 5 response levels on a good-to-bad continuum of 1-5 correspo...
Description	There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to. The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using United Kingdom (UK) weights, health dimensions(mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) into a single index value; the dimensions are not separately scored. The index is marked missing when ≥1 dimensions are missing. The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death. The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	From Randomization Date through End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and with a baseline and at least 1 post-baseline result.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description:	200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	270	183
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	-0.08 (0.01)	-0.08 (0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib, Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.951
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment*Visit + Baseline.

Method of Estimation	Estimation Parameter	LS Mean Change Difference
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95% -0.05 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Resource Utilization: Percentage of Participants Who Are Hospitalized
Description	Resource utilization is the percentage of participants who was hospita...
Description	Resource utilization is the percentage of participants who was hospitalized.
Time Frame	From Randomization Date through End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib	Erlotinib
Arm/Group Description:	200 mg abemaciclib administered, or...	150 mg erlotinib administered, oral...
Arm/Group Description:	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed	265	175
Measure Type: Number Unit of Measure: percentage of participants
	40.4	22.9

Adverse Events

Time Frame	From Baseline to End of Study (Up to 47 Months)
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug.

Arm/Group Title	Abemaciclib		Erlotinib
Arm/Group Description	200 mg abemaciclib administered, or...		150 mg erlotinib administered, oral...
Arm/Group Description	200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).		150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
All-Cause Mortality
	Abemaciclib		Erlotinib
	Affected / at Risk (%)		Affected / at Risk (%)
Total	186/265 (70.19%)		123/175 (70.29%)
Serious Adverse Events Serious Adverse Events
	Abemaciclib		Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	112/265 (42.26%)		43/175 (24.57%)
Blood and lymphatic system disorders
Anaemia ^† 1	3/265 (1.13%)	4	3/175 (1.71%)	3
Febrile bone marrow aplasia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Febrile neutropenia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Neutropenia ^† 1	2/265 (0.75%)	2	0/175 (0.00%)	0
Pancytopenia ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Cardiac disorders
Atrial tachycardia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Cardiac arrest ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Cardiac failure ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Cardiac tamponade ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Cardiopulmonary failure ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pericardial effusion ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Supraventricular tachycardia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Ear and labyrinth disorders
Vertigo positional ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Endocrine disorders
Adrenal insufficiency ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Diarrhoea ^† 1	10/265 (3.77%)	10	0/175 (0.00%)	0
Gastric haemorrhage ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Nausea ^† 1	7/265 (2.64%)	7	0/175 (0.00%)	0
Pancreatitis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Vomiting ^† 1	5/265 (1.89%)	6	2/175 (1.14%)	2
General disorders
Asthenia ^† 1	2/265 (0.75%)	4	0/175 (0.00%)	0
Death ^† 1	2/265 (0.75%)	2	0/175 (0.00%)	0
Fatigue ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
General physical health deterioration ^† 1	3/265 (1.13%)	3	1/175 (0.57%)	1
Malaise ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Non-cardiac chest pain ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Oedema ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pyrexia ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Hepatobiliary disorders
Drug-induced liver injury ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Hepatic failure ^† 1	1/265 (0.38%)	3	0/175 (0.00%)	0
Infections and infestations
Bronchitis ^† 1	2/265 (0.75%)	2	0/175 (0.00%)	0
Cellulitis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Clostridial sepsis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Clostridium difficile colitis ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Empyema ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Enterocolitis infectious ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Lung infection ^† 1	3/265 (1.13%)	4	1/175 (0.57%)	1
Oesophageal candidiasis ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Oral candidiasis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pneumocystis jirovecii pneumonia ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Pneumonia ^† 1	13/265 (4.91%)	15	6/175 (3.43%)	9
Pneumonia bacterial ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pneumonia fungal ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Pyelonephritis acute ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Respiratory tract infection ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Sepsis ^† 1	2/265 (0.75%)	2	2/175 (1.14%)	2
Sepsis pasteurella ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Septic shock ^† 1	2/265 (0.75%)	2	1/175 (0.57%)	2
Skin infection ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Urinary tract infection ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Injury, poisoning and procedural complications
Ankle fracture ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Chemical poisoning ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Fall ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Hip fracture ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Radiation pneumonitis ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Rib fracture ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Spinal compression fracture ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Spinal fracture ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Investigations
Alanine aminotransferase increased ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Aspartate aminotransferase increased ^† 1	2/265 (0.75%)	6	0/175 (0.00%)	0
Blood bilirubin increased ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Blood creatinine increased ^† 1	2/265 (0.75%)	6	0/175 (0.00%)	0
International normalised ratio increased ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Platelet count decreased ^† 1	3/265 (1.13%)	5	0/175 (0.00%)	0
Weight decreased ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Metabolism and nutrition disorders
Decreased appetite ^† 1	3/265 (1.13%)	3	1/175 (0.57%)	1
Dehydration ^† 1	10/265 (3.77%)	12	1/175 (0.57%)	1
Hypercalcaemia ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Hyperglycaemia ^† 1	1/265 (0.38%)	2	2/175 (1.14%)	4
Hyperkalaemia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Hypoalbuminaemia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Hypocalcaemia ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Hypokalaemia ^† 1	2/265 (0.75%)	2	0/175 (0.00%)	0
Hyponatraemia ^† 1	3/265 (1.13%)	3	1/175 (0.57%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/265 (0.00%)	0	2/175 (1.14%)	2
Muscle spasms ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Osteoarthritis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Osteoporosis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Metastases to central nervous system ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Tumour pain ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Nervous system disorders
Aphasia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Cerebral infarction ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Cerebral ischaemia ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Depressed level of consciousness ^† 1	2/265 (0.75%)	2	0/175 (0.00%)	0
Encephalopathy ^† 1	2/265 (0.75%)	3	0/175 (0.00%)	0
Ischaemic stroke ^† 1	2/265 (0.75%)	3	0/175 (0.00%)	0
Neuralgia ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Paraesthesia ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Peripheral sensorimotor neuropathy ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Spinal cord compression ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Syncope ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
Psychiatric disorders
Confusional state ^† 1	3/265 (1.13%)	4	0/175 (0.00%)	0
Suicide attempt ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	10/265 (3.77%)	15	1/175 (0.57%)	1
Anuria ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Renal failure ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Renal impairment ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Acute respiratory failure ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Dyspnoea ^† 1	8/265 (3.02%)	8	7/175 (4.00%)	11
Haemoptysis ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	5
Hypoxia ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	3
Interstitial lung disease ^† 1	1/265 (0.38%)	2	0/175 (0.00%)	0
Laryngeal obstruction ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Laryngeal oedema ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Lung infiltration ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pleural effusion ^† 1	3/265 (1.13%)	3	2/175 (1.14%)	4
Pleuritic pain ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pneumonitis ^† 1	3/265 (1.13%)	6	3/175 (1.71%)	3
Pneumothorax ^† 1	1/265 (0.38%)	1	2/175 (1.14%)	2
Pulmonary cavitation ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Pulmonary embolism ^† 1	4/265 (1.51%)	5	1/175 (0.57%)	1
Pulmonary haemorrhage ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Respiratory failure ^† 1	4/265 (1.51%)	6	1/175 (0.57%)	2
Respiratory tract congestion ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Skin and subcutaneous tissue disorders
Subcutaneous emphysema ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Urticaria ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Vascular disorders
Deep vein thrombosis ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Embolism ^† 1	0/265 (0.00%)	0	1/175 (0.57%)	1
Hypotension ^† 1	2/265 (0.75%)	2	0/175 (0.00%)	0
Peripheral arterial occlusive disease ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Shock haemorrhagic ^† 1	1/265 (0.38%)	1	0/175 (0.00%)	0
Superior vena cava syndrome ^† 1	1/265 (0.38%)	1	1/175 (0.57%)	1
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Abemaciclib		Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	247/265 (93.21%)		161/175 (92.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	87/265 (32.83%)	163	23/175 (13.14%)	30
Neutropenia ^† 1	19/265 (7.17%)	44	1/175 (0.57%)	1
Thrombocytopenia ^† 1	17/265 (6.42%)	25	1/175 (0.57%)	3
Gastrointestinal disorders
Abdominal pain ^† 1	30/265 (11.32%)	34	8/175 (4.57%)	8
Constipation ^† 1	29/265 (10.94%)	32	15/175 (8.57%)	17
Diarrhoea ^† 1	169/265 (63.77%)	331	69/175 (39.43%)	100
Nausea ^† 1	94/265 (35.47%)	127	30/175 (17.14%)	33
Stomatitis ^† 1	14/265 (5.28%)	14	10/175 (5.71%)	10
Vomiting ^† 1	61/265 (23.02%)	89	15/175 (8.57%)	15
General disorders
Asthenia ^† 1	44/265 (16.60%)	82	13/175 (7.43%)	16
Fatigue ^† 1	73/265 (27.55%)	132	29/175 (16.57%)	38
Non-cardiac chest pain ^† 1	15/265 (5.66%)	17	7/175 (4.00%)	7
Pyrexia ^† 1	33/265 (12.45%)	40	11/175 (6.29%)	11
Investigations
Aspartate aminotransferase increased ^† 1	15/265 (5.66%)	26	7/175 (4.00%)	8
Blood creatinine increased ^† 1	45/265 (16.98%)	81	2/175 (1.14%)	2
Neutrophil count decreased ^† 1	40/265 (15.09%)	130	2/175 (1.14%)	4
Platelet count decreased ^† 1	42/265 (15.85%)	103	5/175 (2.86%)	7
Weight decreased ^† 1	42/265 (15.85%)	54	16/175 (9.14%)	22
White blood cell count decreased ^† 1	28/265 (10.57%)	83	4/175 (2.29%)	6
Metabolism and nutrition disorders
Decreased appetite ^† 1	95/265 (35.85%)	133	42/175 (24.00%)	52
Dehydration ^† 1	15/265 (5.66%)	18	1/175 (0.57%)	1
Hypoalbuminaemia ^† 1	18/265 (6.79%)	24	8/175 (4.57%)	15
Hypokalaemia ^† 1	22/265 (8.30%)	31	9/175 (5.14%)	10
Hyponatraemia ^† 1	17/265 (6.42%)	37	6/175 (3.43%)	11
Musculoskeletal and connective tissue disorders
Back pain ^† 1	15/265 (5.66%)	15	11/175 (6.29%)	15
Nervous system disorders
Dizziness ^† 1	18/265 (6.79%)	19	5/175 (2.86%)	6
Headache ^† 1	24/265 (9.06%)	29	11/175 (6.29%)	12
Psychiatric disorders
Insomnia ^† 1	15/265 (5.66%)	16	7/175 (4.00%)	7
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	38/265 (14.34%)	45	21/175 (12.00%)	22
Dyspnoea ^† 1	53/265 (20.00%)	74	22/175 (12.57%)	26
Productive cough ^† 1	16/265 (6.04%)	17	4/175 (2.29%)	4
Skin and subcutaneous tissue disorders
Dermatitis acneiform ^† 1	1/265 (0.38%)	4	46/175 (26.29%)	68
Dry skin ^† 1	14/265 (5.28%)	14	26/175 (14.86%)	35
Pruritus ^† 1	17/265 (6.42%)	22	18/175 (10.29%)	27
Rash ^† 1	11/265 (4.15%)	14	42/175 (24.00%)	68
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Chief Medical Officer
Organization:	Eli Lilly and Company
Phone:	800-545-5979
EMail:	ClinicalTrials.gov@lilly.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Goskel T, Cortot AB, Girard N, Wesseler C, Bischoff H, Nadal E, Park K, Lu S, Taus A, Cobo M, Estrem ST, Wijayawardana SR, Turner K, Oakley GJ 3rd, Hurt KC, Chiang AY, Hossain AM, John WJ, Paz-Ares L. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756. doi: 10.3389/fonc.2020.578756. eCollection 2020.

Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.

Layout table for additonal information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT02152631
Other Study ID Numbers:	15296 I3Y-MC-JPBK ( Other Identifier: Eli Lilly and Company ) 2013-004662-33 ( EudraCT Number )
First Submitted:	May 23, 2014
First Posted:	June 2, 2014
Results First Submitted:	August 23, 2018
Results First Posted:	December 12, 2018
Last Update Posted:	April 18, 2024

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