A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

NCT00606021 | Completed Phase 2 Results

• 2 other identifiers: 11839H3E-EZ-S114
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 5

Brief Summary

This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer. A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival During Maintenance Phase

  Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.

  Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months

Secondary Outcomes (5)

• Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])

  First dose of study drug during IP to PD or date of death from any cause up to 33.6 months

• Overall Survival During Maintenance Phase

  Randomization to PD or date of death from any cause up to 31.3 months

• Overall Survival During Overall Period (IP + MP)

  First dose of study drug during IP to PD or date of death from any cause up to 34.1 months

• Number of Participants With Adverse Events (AEs) During Overall Period

  First dose of study drug during IP through overall study completion (up to 34.3) months

• Tumor Response Rate and Disease Control Rate After Induction Phase (IP)

  Randomization to measured PD up to 31.4 months

Study Arms (2)

A: Pemetrexed + Best Supportive Care

EXPERIMENTAL

Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Drug: pemetrexed; Drug: Best Supportive Care

B: Best Supportive Care

ACTIVE COMPARATOR

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Drug: Best Supportive Care

Interventions

pemetrexed DRUG

500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Also known as: Alimta, LY231514

A: Pemetrexed + Best Supportive Care

Best Supportive Care DRUG

Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

A: Pemetrexed + Best Supportive Care; B: Best Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• You must be at least 18 years old
• You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
• You must have had no prior systemic anticancer therapy for lung cancer
• You must live close enough to the study doctor to be able to visit regularly for follow up
• You must have signed informed consent form indicating your willingness to take part in this study
• Your laboratory and medical history and tests must meet study requirements

You may not qualify if:

• Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
• Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
• Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
• Brain metastasis
• Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
• Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
• Concurrent administration of any other antitumor therapy
• Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
• Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
• Pregnancy or breast-feeding
• You are allergic to pemetrexed

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

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.

Asyut, 0000, Egypt

Location

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.

Cairo, 11372, Egypt

Location

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.

Mounofia, 32514, Egypt

Location

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.

Beirut, Lebanon

Location

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.

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

• Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423.

  PMID: 23006447 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

Due to a mistake in the randomization parameters form, the randomization was actually implemented in the ratio of 1:1 instead of the planned ratio of 2:1.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: February 1, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 26, 2011
• Results First Posted: December 26, 2011

Record last verified: 2011-11

Locations

EG (3); SA (1); LE (1)