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

Purpose

To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Pemetrexed Drug: Carboplatin	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Post-marketing Clinical Trial of Induction Chemotherapy of Pemetrexed Plus Carboplatin Followed by Pemetrexed Maintenance Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.

Secondary Outcome Measures:

Overall Survival (OS) During the Induction and Maintenance Therapy Periods [ Time Frame: Enrollment to the date of death from any cause (up to 30.8 months) ] [ Designated as safety issue: No ]
OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.
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) ] [ Designated as safety issue: No ]
Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria.
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) ] [ Designated as safety issue: No ]
Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria.
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 24.4 months) ] [ Designated as safety issue: No ]
Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
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 26.3 months) ] [ Designated as safety issue: No ]
OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.
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) ] [ Designated as safety issue: No ]
Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
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) ] [ Designated as safety issue: No ]
Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria.
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) ] [ Designated as safety issue: No ]
Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria.


Enrollment:	109
Study Start Date:	November 2009
Study Completion Date:	June 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pemetrexed + Carboplatin After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.	Drug: Pemetrexed Induction Therapy: 500 milligrams per square meter (mg/m^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Maintenance Therapy: 500 mg/m^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity. Other Names: Alimta LY231514 Drug: Carboplatin Dosage equal to 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.

Arms

Assigned Interventions

Experimental: Pemetrexed + Carboplatin

After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.

Drug: Pemetrexed

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

Maintenance Therapy: 500 mg/m^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Other Names:

Alimta
LY231514

Drug: Carboplatin

Dosage equal to 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.

Eligibility


Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease
Clinical stage IIIB/IV or recurrent disease after surgery
No prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
Prior radiation therapy is allowed to less than 25% of the bone marrow
Measurable disease as defined by response evaluation criteria in solid tumors (RECIST)
The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function
Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

Clinically significant third-space fluid collections
Central nervous system disease other than stable and treated brain metastasis
More than 3 weeks interval between the surgery and enrollment request date
Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), for a 5 days period
Unable or unwilling to take folic acid or vitamin B12 supplementation
Unable to take corticosteroids.
Serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
Currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography (CT)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020786

Locations


Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, Japan, 460-0001
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, Japan, 277 8577
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Ehime, Japan, 790-0007
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan, 812-8582
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, Japan, 062-0931
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Hyogo, Japan, 673-8558
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, Japan, 236-0051
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kumamoto, Japan, 860-8556
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miyagi, Japan, 980-8574
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Niigata, Japan, 951-8520
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Okayama, Japan, 700-8558
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, Japan, 589-8511
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shizuoka, Japan, 411-8777
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tochigi, Japan, 320-0834
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, Japan, 113-8677
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yamaguchi, Japan, 755-0241

Sponsors and Collaborators

Eli Lilly and Company

Investigators


Study Director:	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

More Information

No publications provided by Eli Lilly and Company

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

Okamoto I, Aoe K, Kato T, Hosomi Y, Yokoyama A, Imamura F, Kiura K, Hirashima T, Nishio M, Nogami N, Okamoto H, Saka H, Yamamoto N, Yoshizuka N, Sekiguchi R, Kiyosawa K, Nakagawa K, Tamura T. Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer. Invest New Drugs. 2013 Oct;31(5):1275-82. doi: 10.1007/s10637-013-9941-z. Epub 2013 Mar 10. Erratum in: Invest New Drugs. 2013 Oct;31(5):1395-6.


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:	June 19, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Eli Lilly and Company:


Non-squamous

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms	Carboplatin Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015