Non-Small-Cell Lung CancerPhase 2NCT00402051

Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Pemetrexed, Cisplatin and Carboplatin in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 12 sites in Germany.

Completed

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

Official record

Search all trials

Trial summary

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: 133 participants
Where: 12 sitesGermany
Study dates: Nov 2006to May 2009
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

Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
No previous systemic chemotherapy for this cancer
At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Who cannot join

Serious concomitant systemic disorder or active infection
Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
Presence of clinically significant third-space fluid collections

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Germany12 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.
Coswig, D-01640
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.
Frankfurt, 65929
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.
Großhansdorf, D-22927
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.
Halle, D-06120
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.
Hamburg, D-21075
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.
Hofheim, D-65719
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.
Homburg/Saar, 66421
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.
Immenhausen, D-34376
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.
Leipzig, 04207
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.
Lübeck, 23538
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.
Mainz, 55131
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.
München, 81664

Other trials in Germany

About this study

Official title: A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC

This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.

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 mg/m2, intravenous (IV), every 21 days x 6 cycles
CisplatinDrug
75 mg/m2, intravenous (IV), every 21 days x 6 cycles
CarboplatinDrug
Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Study groups in NCT00402051
Study group	Role	What they receive
Pemetrexed + Cisplatin	Experimental	Not described Receives: Drug: Pemetrexed; Drug: Cisplatin
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.

Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.
Measured: Randomization to Month 6

Secondary outcomes (4)

Overall Survival
Defined as the time from randomization to the date of death from any cause.
Measured: Randomization to date of death from any cause (up to 1 year)
Number of Participants With Tumor Response (as Basis for Response Rate)
Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.
Measured: Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression
Time to Treatment Failure (TTF)
Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first
Measured: Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)
Pharmacology Toxicities
Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.
Measured: Every 21-day cycle for up to 6 cycles

Timeline

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

Nov 2006May 2009

First posted22 Nov 2006 (estimated)
Study startNov 2006
Primary completionDec 2008
Study completionMay 2009

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.
Publications (1)Papers the sponsor has linked to this study.
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: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402051
Sponsor's protocol ID: 11077
Other IDs: H3E-SB-S109
Status last verified: Feb 2010
First submitted: 17 Nov 2006
Last updated: 17 Feb 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schuette WH, Groschel A, Sebastian M, Andreas S, Muller T, Schneller F, Guetz S, Eschbach C, Bohnet S, Leschinger MI, Reck M. A randomized phase II study of pemetrexed in combination with cisplatin or carboplatin as first-line therapy for patients with locally advanced or metastatic non-small-cell lung cancer. Clin Lung Cancer. 2013 May;14(3):215-23. doi: 10.1016/j.cllc.2012.10.001. Epub 2013 Jan 16.
PubMed 23332288

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

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-Small-Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2010. 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 in the First Line Therapy of Advanced NSCLC
ClinicalTrials.gov ID: NCT00402051
Acronym / sponsor ID: 11077
Conditions: Non-Small-Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Dec 2008 (actual)
Study completion: May 2009 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 7 Jan 2010

Clinical summary

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

Study design

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

Arm	Type	Receives
Pemetrexed + Cisplatin	Experimental	Drug: Pemetrexed, Drug: Cisplatin
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 (5 listed)

Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
No previous systemic chemotherapy for this cancer
At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Key exclusion criteria (4 listed)

Serious concomitant systemic disorder or active infection
Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
Presence of clinically significant third-space fluid collections

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 mg/m2, intravenous (IV), every 21 days x 6 cycles	Drug	Pemetrexed + Carboplatin, Pemetrexed + Cisplatin
Cisplatin75 mg/m2, intravenous (IV), every 21 days x 6 cycles	Drug	Pemetrexed + Cisplatin
CarboplatinArea under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles	Drug	Pemetrexed + Carboplatin

Primary outcome

Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
Time frame: Randomization to Month 6
For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.

4 secondary outcomes

Overall Survival
Time frame: Randomization to date of death from any cause (up to 1 year)
Number of Participants With Tumor Response (as Basis for Response Rate)
Time frame: Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression
Time to Treatment Failure (TTF)
Time frame: Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)
Pharmacology Toxicities
Time frame: Every 21-day cycle for up to 6 cycles

Results and safety

Results posted to the registry on 7 Jan 2010, 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	66	28
Pemetrexed + Carboplatin	67	32

Primary outcome: Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)

Time frame: Randomization to Month 6. Number. Unit: percentage

Measure	Pemetrexed + Cisplatin n = 65	Pemetrexed + Carboplatin n = 65
Value	52.8 (40.3 to 65.3)	39.3 (27.8 to 50.8)

Pemetrexed + Cisplatin: 6-Month PFS Rate: 52.8 (95% CI 40.3 to 65.3)
Pemetrexed + Carboplatin: 6-Month PFS Rate: 39.3 (95% CI 27.8 to 50.8)

Population analysed: Full Analysis Set: All patients randomized who received at least one dose of study drug

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed + Cisplatin	22 of 65 (33.8%)	61 of 65 (93.8%)	Not reported
Pemetrexed + Carboplatin	28 of 65 (43.1%)	59 of 65 (90.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23332288Schuette WH, Groschel A, Sebastian M, Andreas S, Muller T, Schneller F, Guetz S, Eschbach C, Bohnet S, Leschinger MI, Reck M. A randomized phase II study of pemetrexed in combination with cisplatin or carboplatin as first-line therapy for patients with locally advanced or metastatic non-small-cell lung cancer. Clin Lung Cancer. 2013 May;14(3):215-23. doi: 10.1016/j.cllc.2012.10.001. Epub 2013 Jan 16.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Non-Small-Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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

12 sites in 1 country: 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 12 sites in Germany.

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 4 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. 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 7 Jan 2010). 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?

Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) (time frame: Randomization to Month 6). 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 NCT00402051, which also lists 1 linked publication.

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 17 Feb 2010.