A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT01020786

First received: November 24, 2009

Last updated: August 2, 2012

Last verified: February 2012

History of Changes

Results First Received: January 12, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non Small Cell Lung Cancer
Interventions:	Drug: Pemetrexed Drug: Carboplatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Induction period: pemetrexed and carboplatin were administered for 4 cycles (1 cycle=21 days). Participants with documented complete response (CR), partial response (PR), or stable disease (SD) entered the maintenance therapy period (fifth cycle and after). Maintenance period: pemetrexed monotherapy until a discontinuation criterion was met.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Induction period: pemetrexed and carboplatin were administered for 4 cycles (1 cycle=21 days). Participants with documented complete response (CR), partial response (PR), or stable disease (SD) entered the maintenance therapy period (fifth cycle and after).

Maintenance period: pemetrexed monotherapy until a discontinuation criterion was met.

Reporting Groups

	Description
Pemetrexed + Carboplatin	Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Description

Pemetrexed + Carboplatin

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Participant Flow for 2 periods

Period 1: Induction Period

	Pemetrexed + Carboplatin
STARTED	109
COMPLETED	60 ^[1]
NOT COMPLETED	49
Entry Criteria Not Met	2
Adverse Event	9
Progressive Disease	31
Investigator Decision	3
Withdrawal by Subject	4

[1]	Completed induction therapy. Completed=starting the maintenance therapy.

Period 2: Maintenance Period

	Pemetrexed + Carboplatin
STARTED	60
COMPLETED	9 ^[1]
NOT COMPLETED	51
Adverse Event	8
Progressive Disease	38
Withdrawal by Subject	5

[1]	Continuing study treatment.

Baseline Characteristics

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Reporting Groups

	Description
Pemetrexed + Carboplatin	Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Description

Pemetrexed + Carboplatin

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Baseline Measures

	Pemetrexed + Carboplatin
Number of Participants [units: participants]	109
Age [units: years] Mean ± Standard Deviation	63.35 ± 8.692
Gender [units: participants]
Female	40
Male	69
Race/Ethnicity, Customized [units: participants]
Japanese	109
Region of Enrollment [units: participants]
Japan	109
Percentage of Participants in Each Smoking Status Category at Study Entry ^[1] [units: percentage of participants]
Current Smoker	8.3
Former Smoker	61.5
Never Smoker	30.3
Unknown	0.0
Percentage of Participants in Each Histology Category ^[2] [units: percentage of participants]
Adenocarcinoma Lung	96.3
Large Cell Lung Carcinoma	2.8
Carcinoma, Non-small Cell, Lung Not Otherwise S	0.9
Percentage of Participants in Each Disease Stage ^[3] [units: percentage of participants]
Stage IIIb	30.3
Stage IV	66.1
Other	3.7
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category ^[4] [units: percentage of participants]
Positive	22.0
Negative	57.8
Unknown	2.8
Not Done	17.4
Percentage of Participants in Each Eastern Cooperative Oncology Group (ECOG) Status ^[5] [units: percentage of participants]
0 - Fully Active	33.9
1 - Ambulatory, Restricted Strenuous Activity	66.1

[1]	Percentage of participants in each category for smoking status. All of the percentages do not add up to 100% because of rounding.
[2]	Percentage of participants in each of the following categories: adenocarcinoma, large cell lung carcinoma, and carcinoma, non-small cell, lung not otherwise specified (NOS).
[3]	Percentage of participants in each disease stage category. Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body. Stage IIIB - cancer spread to opposite side of chest, more than 1 tumor within same lobe of lung; Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver. All of the percentages do not add up to 100% because of rounding.
[4]	Percentage of participants in each EGFR mutation status category.
[5]	ECOG Performance Status (PS). Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active - Ambulatory, Restricted Strenuous Activity - Ambulatory, No Work Activities - Partially Confined to Bed, Limited Self Care - Completely Disabled - Death

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods [ Time Frame: Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months) ]

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2. Secondary:

Overall Survival (OS) During the Induction and Maintenance Therapy Periods [ Time Frame: Enrollment to the date of death from any cause (up to 2 years) ]

Show Outcome Measure 2

3. Secondary:

Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods [ Time Frame: Enrollment to date of progressive disease (up to 18 months) ]

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4. Secondary:

Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods [ Time Frame: Enrollment to date of progressive disease (up to 18 months) ]

Show Outcome Measure 4

5. Secondary:

Progression Free Survival (PFS) During the Maintenance Therapy Period [ Time Frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months) ]

Show Outcome Measure 5

6. Secondary:

Overall Survival (OS) During the Maintenance Therapy Period [ Time Frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 2 years) ]

Show Outcome Measure 6

7. Secondary:

Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period [ Time Frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months) ]

Show Outcome Measure 7

8. Secondary:

Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period [ Time Frame: Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle) ]

Show Outcome Measure 8

9. Secondary:

Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period [ Time Frame: Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle) ]

Show Outcome Measure 9

Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Pemetrexed + Carboplatin	Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Description

Pemetrexed + Carboplatin

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Other Adverse Events

	Pemetrexed + Carboplatin
Total, other (not including serious) adverse events
# participants affected / at risk	109/109
Blood and lymphatic system disorders
Anaemia ^{† 1}
# participants affected / at risk	47/109 (43.12%)
# events	54
Leukopenia ^{† 1}
# participants affected / at risk	44/109 (40.37%)
# events	140
Lymphopenia ^{† 1}
# participants affected / at risk	14/109 (12.84%)
# events	23
Neutropenia ^{† 1}
# participants affected / at risk	56/109 (51.38%)
# events	183
Thrombocytopenia ^{† 1}
# participants affected / at risk	30/109 (27.52%)
# events	80
Gastrointestinal disorders
Abdominal pain ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	14
Abdominal pain upper ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	7
Cheilitis ^{† 1}
# participants affected / at risk	6/109 (5.50%)
# events	6
Constipation ^{† 1}
# participants affected / at risk	52/109 (47.71%)
# events	88
Diarrhoea ^{† 1}
# participants affected / at risk	24/109 (22.02%)
# events	36
Nausea ^{† 1}
# participants affected / at risk	81/109 (74.31%)
# events	203
Stomatitis ^{† 1}
# participants affected / at risk	21/109 (19.27%)
# events	26
Vomiting ^{† 1}
# participants affected / at risk	46/109 (42.20%)
# events	71
General disorders
Fatigue ^{† 1}
# participants affected / at risk	75/109 (68.81%)
# events	157
Influenza like illness ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	8
Injection site reaction ^{† 1}
# participants affected / at risk	10/109 (9.17%)
# events	10
Malaise ^{† 1}
# participants affected / at risk	12/109 (11.01%)
# events	19
Oedema ^{† 1}
# participants affected / at risk	6/109 (5.50%)
# events	6
Pyrexia ^{† 1}
# participants affected / at risk	34/109 (31.19%)
# events	55
Infections and infestations
Nasopharyngitis ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	8
Pneumonia ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	10
Investigations
Alanine aminotransferase increased ^{† 1}
# participants affected / at risk	62/109 (56.88%)
# events	147
Aspartate aminotransferase increased ^{† 1}
# participants affected / at risk	60/109 (55.05%)
# events	149
Blood albumin decreased ^{† 1}
# participants affected / at risk	15/109 (13.76%)
# events	19
Blood alkaline phosphatase increased ^{† 1}
# participants affected / at risk	20/109 (18.35%)
# events	22
Blood bilirubin increased ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	12
Blood calcium decreased ^{† 1}
# participants affected / at risk	11/109 (10.09%)
# events	17
Blood creatinine increased ^{† 1}
# participants affected / at risk	9/109 (8.26%)
# events	17
Blood lactate dehydrogenase increased ^{† 1}
# participants affected / at risk	38/109 (34.86%)
# events	66
Blood potassium increased ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	11
Blood sodium decreased ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	15
Blood urea increased ^{† 1}
# participants affected / at risk	10/109 (9.17%)
# events	16
Gamma-glutamyltransferase increased ^{† 1}
# participants affected / at risk	30/109 (27.52%)
# events	41
Haemoglobin decreased ^{† 1}
# participants affected / at risk	52/109 (47.71%)
# events	76
Neutrophil count decreased ^{† 1}
# participants affected / at risk	30/109 (27.52%)
# events	94
Platelet count decreased ^{† 1}
# participants affected / at risk	65/109 (59.63%)
# events	221
Red blood cell count decreased ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	8
Weight decreased ^{† 1}
# participants affected / at risk	11/109 (10.09%)
# events	15
White blood cell count decreased ^{† 1}
# participants affected / at risk	42/109 (38.53%)
# events	128
Metabolism and nutrition disorders
Decreased appetite ^{† 1}
# participants affected / at risk	82/109 (75.23%)
# events	175
Hypocalcaemia ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	15
Hyponatraemia ^{† 1}
# participants affected / at risk	6/109 (5.50%)
# events	6
Musculoskeletal and connective tissue disorders
Back pain ^{† 1}
# participants affected / at risk	14/109 (12.84%)
# events	15
Myalgia ^{† 1}
# participants affected / at risk	6/109 (5.50%)
# events	7
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	20/109 (18.35%)
# events	27
Dysgeusia ^{† 1}
# participants affected / at risk	11/109 (10.09%)
# events	13
Headache ^{† 1}
# participants affected / at risk	15/109 (13.76%)
# events	20
Peripheral sensory neuropathy ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	10
Psychiatric disorders
Insomnia ^{† 1}
# participants affected / at risk	23/109 (21.10%)
# events	28
Respiratory, thoracic and mediastinal disorders
Cough ^{† 1}
# participants affected / at risk	16/109 (14.68%)
# events	18
Dyspnoea ^{† 1}
# participants affected / at risk	12/109 (11.01%)
# events	14
Epistaxis ^{† 1}
# participants affected / at risk	9/109 (8.26%)
# events	10
Haemoptysis ^{† 1}
# participants affected / at risk	7/109 (6.42%)
# events	11
Hiccups ^{† 1}
# participants affected / at risk	17/109 (15.60%)
# events	31
Skin and subcutaneous tissue disorders
Alopecia ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	8
Pruritus ^{† 1}
# participants affected / at risk	10/109 (9.17%)
# events	12
Rash ^{† 1}
# participants affected / at risk	35/109 (32.11%)
# events	45
Skin hyperpigmentation ^{† 1}
# participants affected / at risk	8/109 (7.34%)
# events	8

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 14.0

More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01020786 History of Changes
Other Study ID Numbers:	12628, H3E-JE-JMII
Study First Received:	November 24, 2009
Results First Received:	January 12, 2012
Last Updated:	August 2, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency

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