Non-small Cell Lung CancerPhase 3ACENCT01593293
Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer
A Phase 3 study testing PemCarbo and Pem only in people with Non-small Cell Lung Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- PemCarbo and Pem only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th)
- Age 70 years old or older
- Eastern Cooperative Oncology Group performance status 0-1
- Measurable or assessable disease as defined by RECIST 1.1
- Estimated life expectancy of more than 3 months
- Adequate bone marrow function(Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobulin ≥ 9 g/dL)
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- Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥45 ml/min
- Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 3 x UNL, alkaline phosphatase < 3 x UNL (except in case of bone metastasis without any liver disease)
- Written informed consent
Who cannot join
- Prior systemic chemotherapy or biological therapy
- Contraindication to any drug contained in the chemotherapy regimen
- Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment
- Active infection which would compromise the patient's ability to tolerate treatment
- Requirement for major surgery within 4 weeks of study entry
- Myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months
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- Unable to discontinue administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Aspirin or NSAIDs should be at least 5 days before pemetrexed administration
- Presence or history of CNS metastasis (except if adequately treated and is not receiving steroid therapy for at least 2 weeks; at least 2 weeks for whole brain radiation or at least 1 week for gamma knife surgery)
- Peripheral neuropathy ≥ grade 2
- History of another malignancy within the last five years except cured basal cell carcinoma of skin, cured carcinoma in-situ of uterine cervix and cured thyroid malignancy
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Sang-We Kim, M.D., 82-2-3010-3215, swkim@amc.seoul.kr
About this study
Official title: A Randomized, Open-label, Phase III Study Comparing Pemetrexed With and Without Carboplatin in Elderly Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.
Read the detailed description
The treatment of NSCLC in elderly has been subject to discussion for years. While platinum doublets consisting of cisplatin or carboplatin and another cytotoxic agent demonstrate a survival advantage compared with single agents generally, evidence of treatment efficacy for patients with diminished performance status (PS) or with age older than 70 years is limited. Guidelines from the US and Europe have preferred single-agent chemotherapy for the elderly and PS 2 patients. However, increasing studies are exploring this issue and presenting data that favour doublet therapy. The addition of carboplatin to paclitaxel and cisplatin to docetaxel have shown evidence that patients over 70 benefit more in face of increased toxicities.
This study is designed to be multi-center, open-label, prospective, randomized, two-arm, parallel, phase III trial of elderly patients(≥70 years old) with metastatic non-squamous NSCLC (Stage IV by AJCC 7th) who have not received prior systemic chemotherapy or biological therapy. Approximately 266 patients will be enrolled into the trial. This study compares the doublet therapy of pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL*min) administered intravenously every 21 days for 4 cycles followed by pemetrexed (500 mg/m2) every 21 days for maintenance therapy (Arm A) to single therapy of pemetrexed (500 mg/m2) every 21 days till progression or unacceptable toxicity (Arm B). Pemetrexed will be administered with vitamin B12 and folate supplements.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- PemCarbo, Pem only
- Keywords
- Elderly patients, Non-squamous Non-small Cell Lung Cancer, Pemetrexed, Carboplatin
- 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.
PemCarboDrug
Also called Alimta: brand name of Pemetrexed
Pemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy
Pem onlyDrug
Also called Alimta: brand name of pemetrexed
Pemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| PemCarbo | Active comparator | Pemetrexed/Carboplatin arm Receives: Drug: PemCarbo |
| Pem only | Active comparator | Pemetrexed arm Receives: Drug: Pem only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.
Measured: The study lasts for 30 months of which subject accrual occurs in the first 24 months
Secondary outcomes (1)
Objective response rate, Overall survival, Safety and Quality of life
- To compare the following efficacy variables between treatment arms:
- Objective response rate
- Overall survival
- To compare the safety and adverse event profile between treatment arms
- To assess the impact of treatment on patient-rated quality of life (FACT-L)
Measured: The study lasts for 30 months of which subject accrual occurs in the first 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Korean Cancer Study Group
- Responsible party
- Principal investigator, Sang-We Kim, Asan Medical Center
- Investigators
- Sang-We Kim, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593293
- Sponsor's protocol ID
- AMC 2011-0857
- Other IDs
- AMC 2011-0857
- Acronym
- ACE
- Status last verified
- May 2012
- First submitted
- 11 Jan 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase III Study Comparing Pemetrexed With and Without Carboplatin in Elderly Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01593293
- Acronym / sponsor ID
- ACE / AMC 2011-0857
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Elderly patients, Non-squamous Non-small Cell Lung Cancer, Pemetrexed, Carboplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Korean Cancer Study Group
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.
Detailed description
The treatment of NSCLC in elderly has been subject to discussion for years. While platinum doublets consisting of cisplatin or carboplatin and another cytotoxic agent demonstrate a survival advantage compared with single agents generally, evidence of treatment efficacy for patients with diminished performance status (PS) or with age older than 70 years is limited. Guidelines from the US and Europe have preferred single-agent chemotherapy for the elderly and PS 2 patients. However, increasing studies are exploring this issue and presenting data that favour doublet therapy. The addition of carboplatin to paclitaxel and cisplatin to docetaxel have shown evidence that patients over 70 benefit more in face of increased toxicities.
This study is designed to be multi-center, open-label, prospective, randomized, two-arm, parallel, phase III trial of elderly patients(≥70 years old) with metastatic non-squamous NSCLC (Stage IV by AJCC 7th) who have not received prior systemic chemotherapy or biological therapy. Approximately 266 patients will be enrolled into the trial. This study compares the doublet therapy of pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL*min) administered intravenously every 21 days for 4 cycles followed by pemetrexed (500 mg/m2) every 21 days for maintenance therapy (Arm A) to single therapy of pemetrexed (500 mg/m2) every 21 days till progression or unacceptable toxicity (Arm B). Pemetrexed will be administered with vitamin B12 and folate supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PemCarbo | Active comparator | Drug: PemCarboPemetrexed/Carboplatin arm |
| Pem only | Active comparator | Drug: Pem onlyPemetrexed arm |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th)
- Age 70 years old or older
- Eastern Cooperative Oncology Group performance status 0-1
- Measurable or assessable disease as defined by RECIST 1.1
- Estimated life expectancy of more than 3 months
Key exclusion criteria (12 listed)
- Prior systemic chemotherapy or biological therapy
- Contraindication to any drug contained in the chemotherapy regimen
- Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment
- Active infection which would compromise the patient's ability to tolerate treatment
- Requirement for major surgery within 4 weeks of study entry
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 |
|---|---|---|
| PemCarboAlso: Alimta: brand name of PemetrexedPemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy | Drug | PemCarbo |
| Pem onlyAlso: Alimta: brand name of pemetrexedPemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity. | Drug | Pem only |
Primary outcome
Progression free survival
Time frame: The study lasts for 30 months of which subject accrual occurs in the first 24 months
To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.
1 secondary outcome
Objective response rate, Overall survival, Safety and Quality of life
Time frame: The study lasts for 30 months of which subject accrual occurs in the first 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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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.
Sang-We Kim, M.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PemCarbo and Pem only in people with Non-small Cell Lung Cancer, run by Asan Medical Center at 1 site in South Korea.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-We Kim, M.D. (82-2-3010-3215, swkim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: The study lasts for 30 months of which subject accrual occurs in the first 24 months). 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 8 May 2012.