Non-Small-Cell Lung CancerPhase 1/2NCT00482014
A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer
A Phase 1/2 study testing pemetrexed, cisplatin and carboplatin in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 11 sites in 2 countries.
Trial summary
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- pemetrexed, cisplatin and carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesin 2 countries
- Study dates
- May 2007to Oct 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inoperable non small cell lung cancer
- No weight loss greater than 10% in 3 months prior to enrolling in trial
- Adequate kidney function
- Adequate liver function
- Adequate lung function
Who cannot join
- Previous surgery to remove lung tumor
- Previous chemotherapy or radiation therapy or lung cancer
- Inability to take vitamin supplementation
- Heart attack within past 6 months
- Active infection
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
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.
Burlington, North Carolina, 27216
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.
Corpus Christi, Texas, 78405
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.
Dallas, Texas, 75390
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.
Las Vegas, Nevada, 89135
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.
Los Angeles, California, 90095
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.
Memphis, Tennessee, 38120
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.
St Louis, Missouri, 63110
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.
Temple, Texas, 76508
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.
Wichita, Kansas, 67214
India2 sites
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.
Delhi, 110085
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.
Trivandrum, 695 011
About this study
Official title: Phase 1/2 Study of Pemetrexed (Alimta) Plus Carboplatin, or Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Pemetrexed Consolidation in Patients With Favorable-Prognosis Inoperable Stage IIIA/B Non-Small-Cell Lung Cancer (NSCLC)
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- pemetrexed, cisplatin, carboplatin, radiation therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called LY231514, Alimta
Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles
Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase
cisplatinDrug
Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43
Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles
carboplatinDrug
Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min), administered intravenously, Days 1, 8, 22, 29 and 43
Phase 2 - dosed at AUC 5 mg/mL*min, administered intravenously, every 21 days for 3 cycles
radiation therapyRadiation
Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51
Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45
| Study group | Role | What they receive |
|---|---|---|
| A: Pemetrexed + Carboplatin | Experimental | Pemetrexed + Carboplatin Receives: Drug: pemetrexed; Drug: carboplatin; Radiation: radiation therapy |
| B: Pemetrexed + Cisplatin | Experimental | Pemetrexed + Cisplatin Receives: Drug: pemetrexed; Drug: cisplatin; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Measured: Phase 1 enrollment to the end of study treatment up to Week 11
Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Measured: Phase 1 enrollment to the end of study treatment up to Week 11
Phase 2 - Survival Probability at 2 Years
Measured: Phase 2 randomization up to 2 years
Secondary outcomes (6)
Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)
Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.
Measured: Phase 1 enrollment up to Week 11
Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Measured: Phase 1 enrollment to the end of the study treatment up to Week 11
Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events
Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.
Measured: Phase 2 randomization to the end of the study treatment up to 30.0 months
Phase 2 - Time to Progression
Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Measured: Phase 2 randomization to measured disease progression up to 24 months
Phase 2 - Median Survival
Measured: Phase 2 randomization to death as the result of any cause up to 30.0 month
Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Measured: Phase 2 randomization to the end of the treatment up to 30.0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482014
- Sponsor's protocol ID
- 9031
- Other IDs
- H3E-US-S047
- Status last verified
- Oct 2012
- First submitted
- 31 May 2007
- Last updated
- 27 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Pemetrexed (Alimta) Plus Carboplatin, or Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Pemetrexed Consolidation in Patients With Favorable-Prognosis Inoperable Stage IIIA/B Non-Small-Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00482014
- Acronym / sponsor ID
- 9031
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Posted 27 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Pemetrexed + Carboplatin | Experimental | Drug: pemetrexed, Drug: carboplatin, Radiation: radiation therapyPemetrexed + Carboplatin |
| B: Pemetrexed + Cisplatin | Experimental | Drug: pemetrexed, Drug: cisplatin, Radiation: radiation therapyPemetrexed + Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inoperable non small cell lung cancer
- No weight loss greater than 10% in 3 months prior to enrolling in trial
- Adequate kidney function
- Adequate liver function
- Adequate lung function
Key exclusion criteria (5 listed)
- Previous surgery to remove lung tumor
- Previous chemotherapy or radiation therapy or lung cancer
- Inability to take vitamin supplementation
- Heart attack within past 6 months
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedAlso: LY231514, AlimtaPhase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase | Drug | A: Pemetrexed + Carboplatin, B: Pemetrexed + Cisplatin |
| cisplatinPhase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles | Drug | B: Pemetrexed + Cisplatin |
| carboplatinPhase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min), administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - dosed at AUC 5 mg/mL*min, administered intravenously, every 21 days for 3 cycles | Drug | A: Pemetrexed + Carboplatin |
| radiation therapyPhase 1 - 2 Gray, daily, 5 days a week for Days 1-51 Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45 | Radiation | A: Pemetrexed + Carboplatin, B: Pemetrexed + Cisplatin |
Primary outcome
Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin
Time frame: Phase 1 enrollment to the end of study treatment up to Week 11
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin
Time frame: Phase 1 enrollment to the end of study treatment up to Week 11
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Phase 2 - Survival Probability at 2 Years
Time frame: Phase 2 randomization up to 2 years
6 secondary outcomes
Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Phase 1 enrollment up to Week 11
Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Time frame: Phase 1 enrollment to the end of the study treatment up to Week 11
Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events
Time frame: Phase 2 randomization to the end of the study treatment up to 30.0 months
Phase 2 - Time to Progression
Time frame: Phase 2 randomization to measured disease progression up to 24 months
Phase 2 - Median Survival
Time frame: Phase 2 randomization to death as the result of any cause up to 30.0 month
Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Time frame: Phase 2 randomization to the end of the treatment up to 30.0 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pemetrexed, cisplatin and carboplatin in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin (time frame: Phase 1 enrollment to the end of study treatment up to Week 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.