Non-Small Cell Lung CancerPhase 2NCT00269152

Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

A Phase 2 study testing pemetrexed, cisplatin and carboplatin in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC). 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 18 sitesin 3 countries
Study dates: Dec 2005to Jul 2013
Phase: Phase 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

Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
Must have complete tumor resection by pneumonectomy or lobectomy
Must have been surgically proven to be N2 negative

Who cannot join

Serious concomitant systemic disorder
Post-operative complications or other surgery related conditions
A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

Germany10 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.
Bad Berka, 99437
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Bielefeld, D-33604
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Cologne, D-51109
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Großhansdorf, D-22927
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Halle, D-06120
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Hanover, D-30625
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Kassel, 34125
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Löwenstein, 74245
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Mainz, D-55131
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Mannheim, 68167

Other trials in Germany

France5 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.
Bordeaux, 33076
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Paris, 75571
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.
Rennes, 35033
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Saint-Priest-en-Jarez, 42270
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Toulouse, 31059

Other trials in France

Spain3 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.
Barcelona, 08036
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.
Madrid, 28046
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.
Santiago de Compostela, 15706

Other trials in Spain

About this study

Official title: A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Conditions: Non-Small Cell Lung Cancer
Being tested: pemetrexed, cisplatin, 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.

pemetrexedDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles
cisplatinDrug
75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
carboplatinDrug
area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles

Study groups in NCT00269152
Study group	Role	What they receive
A: Pemetrexed + Cisplatin	Experimental	Not described Receives: Drug: pemetrexed; Drug: cisplatin
B: Pemetrexed + Carboplatin	Experimental	Not described Receives: Drug: pemetrexed; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

The Feasibility of Post-Surgery Chemotherapy
Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.
Measured: every 21-day cycle for 4 cycles up to 30 days after last infusion

Secondary outcomes (4)

Grade III/IV Adverse Events
Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
Measured: every 21-day cycle for 4 cycles
Overall Survival at 3 Years
For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
Measured: baseline to date of death from any cause, assessed at 3 years
3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years
For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.
Measured: length of time disease free, assessed at 3 years
Overall Survival at 6 Years
For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
Measured: Baseline to date of death from any cause assessed at 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Jul 2013

First posted23 Dec 2005 (estimated)
Study startDec 2005
Primary completionNov 2007
Study completionJul 2013

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00269152
Sponsor's protocol ID: 10105
Other IDs: H3E-SB-S089
Status last verified: Jul 2015
First submitted: 21 Dec 2005
Last updated: 18 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00269152
Acronym / sponsor ID: 10105
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Nov 2007 (actual)
Study completion: Jul 2013 (actual)
First posted: 23 Dec 2005 (estimated)
Results: Posted 11 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A: Pemetrexed + Cisplatin	Experimental	Drug: pemetrexed, Drug: cisplatin
B: Pemetrexed + Carboplatin	Experimental	Drug: pemetrexed, Drug: carboplatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
Must have complete tumor resection by pneumonectomy or lobectomy
Must have been surgically proven to be N2 negative

Key exclusion criteria (3 listed)

Serious concomitant systemic disorder
Post-operative complications or other surgery related conditions
A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago

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, Alimta500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles	Drug	A: Pemetrexed + Cisplatin, B: Pemetrexed + Carboplatin
cisplatin75 mg/m^2, intravenous (IV), every 21 days x 4 cycles	Drug	A: Pemetrexed + Cisplatin
carboplatinarea under the curve (AUC) 5 milligrams per milliliterminute (mg/mlmin), intravenous (IV), every 21 days x 4 cycles	Drug	B: Pemetrexed + Carboplatin

Primary outcome

The Feasibility of Post-Surgery Chemotherapy
Time frame: every 21-day cycle for 4 cycles up to 30 days after last infusion
Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.

4 secondary outcomes

Grade III/IV Adverse Events
Time frame: every 21-day cycle for 4 cycles
Overall Survival at 3 Years
Time frame: baseline to date of death from any cause, assessed at 3 years
3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years
Time frame: length of time disease free, assessed at 3 years
Overall Survival at 6 Years
Time frame: Baseline to date of death from any cause assessed at 6 years

Results and safety

Results posted to the registry on 11 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pemetrexed + Cisplatin	63	45
Pemetrexed + Carboplatin	59	49

Primary outcome: The Feasibility of Post-Surgery Chemotherapy

Time frame: every 21-day cycle for 4 cycles up to 30 days after last infusion. Number. Unit: participants

Measure	Pemetrexed + Cisplatin n = 64	Pemetrexed + Carboplatin n = 54
Participants "feasible"	38	27
Non-feasible = Early Discontinuation	18	6
Non-feasible = Lost to Follow-up	1	2
Non-feasible = Remaining Grade 3/4 Toxicity	4	3
Non-feasible = Underdosage (<95% intended dose)	5	19

Pemetrexed + Cisplatin: Feasibility Response Rate (percentage): 59.4 (95% CI 46.4 to 71.5)
Pemetrexed + Carboplatin: Feasibility Response Rate (percentage): 50.0 (95% CI 36.1 to 63.9)

Population analysed: Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline through four 21-day cycles and up to 30 days of follow-up after last infusion. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed + Cisplatin	18 of 64 (28.1%)	61 of 64 (95.3%)	Not reported
Pemetrexed + Carboplatin	5 of 54 (9.3%)	52 of 54 (96.3%)	Not reported

Limitations and caveats (from the sponsor): A protocol amendment was approved after the trial original completed to allow for collection of additional overall survival data due to number of participants surviving at 3 years.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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RecruitingObservational study
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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 chair

Eli Lilly and Company

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed, cisplatin and carboplatin in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 18 sites in 3 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 3 inclusion and 3 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 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany, France, Spain. 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 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 11 Jun 2009). 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?

The Feasibility of Post-Surgery Chemotherapy (time frame: every 21-day cycle for 4 cycles up to 30 days after last infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00269152.

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 18 Aug 2015.