Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00447057

First received: March 9, 2007

Last updated: September 12, 2011

Last verified: September 2011

History of Changes

Results First Received: June 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
Interventions:	Drug: Pemetrexed Drug: Erlotinib

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
This is a 2-arm study; however, results for participant disposition and baseline characteristics are presented for 4 groups including each study arm (Pemetrexed and Pemetrexed + Erlotinib) by histology (Nonsquamous and Squamous). Efficacy results are presented for participants with nonsquamous histology only.

Reporting Groups

	Description
Pemetrexed (Nonsquamous)	Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
Pemetrexed + Erlotinib (Nonsquamous)	Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle
Pemetrexed (Squamous)	Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Pemetrexed + Erlotinib (Squamous)	Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle

Participant Flow: Overall Study

	Pemetrexed (Nonsquamous)	Pemetrexed + Erlotinib (Nonsquamous)	Pemetrexed (Squamous)	Pemetrexed + Erlotinib (Squamous)
STARTED	83	76	19	26
COMPLETED	0	3	0	0
NOT COMPLETED	83	73	19	26
Adverse Event	4	10	0	3
Death due to study disease	6	4	1	1
Lost to Follow-up	0	1	0	0
Entry criteria not met	1	1	0	0
Protocol Violation	0	1	0	0
Withdrawal by Subject	4	5	1	1
Physician Decision	9	6	3	1
Sponsor decision	1	1	0	0
Progressive disease	58	43	13	18
Death due to adverse event	0	0	1	2
Death, study drug related	0	1	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Pemetrexed (Nonsquamous)	Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Pemetrexed + Erlotinib (Nonsquamous)	Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
Pemetrexed (Squamous)	Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Pemetrexed + Erlotinib (Squamous)	Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle
Total	Total of all reporting groups

Baseline Measures

	Pemetrexed (Nonsquamous)	Pemetrexed + Erlotinib (Nonsquamous)	Pemetrexed (Squamous)	Pemetrexed + Erlotinib (Squamous)	Total
Number of Participants [units: participants]	83	76	19	26	204
Age [units: years] Mean (Standard Deviation)	59.8 (10.25)	63.5 (9.70)	63.9 (9.33)	66.1 (8.58)	62.3 (9.96)
Gender [units: participants]
Female	34	30	0	2	66
Male	49	46	19	24	138
Race/Ethnicity, Customized [units: participants]
Caucasian	82	75	19	26	202
African	0	0	0	0	0
Hispanic	1	0	0	0	1
Native American	0	0	0	0	0
East Asian	0	0	0	0	0
West Asian	0	1	0	0	1
Region of Enrollment [units: participants]
Austria	4	5	2	0	11
Germany	44	37	6	15	102
Spain	18	9	7	7	41
Hungary	12	14	4	4	34
Sweden	5	11	0	0	16
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] [units: Participants]
Status 0	33	33	7	9	82
Status 1	39	33	7	13	92
Status 2	11	9	5	4	29
Unknown	0	1	0	0	1
Basis for Diagnosis [units: participants]
Histopathological	64	61	18	22	165
Cytological	19	15	1	4	39
Initial Pathological Diagnosis [units: participants]
Adenocarcinoma of the lung	70	61	0	0	131
Mixed cell (squamous/adenocarcinoma)	1	1	0	0	2
Large cell lung carcinoma	6	9	0	0	15
Bronchioalveolar carcinoma	4	1	0	0	5
Squamous cell carcinoma of the lung	0	0	19	26	45
Unknown	2	4	0	0	6
Stage of Disease at Study Entry ^[2] [units: participants]
Stage I	0	0	0	0	0
Stage II	0	0	0	0	0
Stage IIIA	3	1	2	0	6
Stage IIIB	10	11	4	5	30
Stage IV	70	64	13	21	168
Smoking status [units: participants]
Never smoked	14	10	0	0	24
Ex-smoker	44	51	12	19	126
Current smoker	25	15	7	7	54
Pack-years, smokers only ^[3] [units: participants]
Up to 15 pack-years	5	13	1	1	20
More than 15 pack-years	60	48	15	25	148
Unknown	18	15	3	0	36

[1]	Eastern Cooperative Oncology Group (ECOG) Performance Status classifies patients 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
[2]	Disease 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 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver
[3]	Pack-year equals the number of cigarette packs smoked per day multiplied by the number of years the participant has smoked. For example, 1 pack-year is equal to smoking an average of 20 cigarettes per day (1 pack) for 1 year.

[1]

Eastern Cooperative Oncology Group (ECOG) Performance Status classifies patients 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

[2]

Disease 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 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver

[3]

Pack-year equals the number of cigarette packs smoked per day multiplied by the number of years the participant has smoked. For example, 1 pack-year is equal to smoking an average of 20 cigarettes per day (1 pack) for 1 year.

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) [ Time Frame: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months ]

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2. Secondary:

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate) [ Time Frame: Baseline to measured PD. Maximum follow-up was from Baseline to 34 months ]

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3. Secondary:

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate) [ Time Frame: Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months ]

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4. Secondary:

Time to Treatment Failure (TTTF) [ Time Frame: Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months ]

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5. Secondary:

Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months. ]

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6. Secondary:

Percentage of Participants Surviving at 1 Year [ Time Frame: Baseline to date of death from any cause up to 1 year ]

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7. Secondary:

Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 42.2 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
Baseline Characteristics are presented by histology (nonsquamous/squamous) for each arm. Per the protocol amendment of August 2008, study entry criteria were changed to exclude participants with predominantly squamous cell histology.

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.

Results Point of Contact:

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

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00447057 History of Changes
Other Study ID Numbers:	10721 H3E-MC-S102 ( Other Identifier: Eli Lilly and Company )
Study First Received:	March 9, 2007
Results First Received:	June 17, 2011
Last Updated:	September 12, 2011
Health Authority:	Austria: Agency for Health and Food Safety Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Spain: Ministry of Health

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