Non-Small Cell Lung CancerPhase 2NCT00191308

Molecular Profiling in Lung Cancer Patients

A Phase 2 study testing pemetrexed, cisplatin and Radical Non-Small Cell Lung Cancer (NSCLC) surgery in people with Non-Small Cell Lung Cancer and Carcinoma, run by Eli Lilly and Company at 3 sites in Poland.

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

The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer, Carcinoma
What is being tested?: pemetrexed, cisplatin and Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesPoland
Study dates: May 2005to Dec 2010
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

pathologic documentation of non-small cell lung cancer (NSCLC)
tumor must be accessible by bronchoscopy for tumor tissue sample collection
patients must have lung cancer with clinical stage IB, II, IIIA
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)

Who cannot join

bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
pregnant or breast feeding patients
patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
unwillingness to take folic acid or vitamin B12 supplementation

Trial locations and contacts

3 sites in 1 country.

Poland3 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.
Bystra, 43-360
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.
Poznan, 60-569
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.
Warsaw, 02-781

Other trials in Poland

About this study

Official title: Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy

Conditions: Non-Small Cell Lung Cancer, Carcinoma
Being tested: pemetrexed, cisplatin, Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Carcinoma

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/m^2 IV q 21 days for 3 cycles unless disease progression occurs
cisplatinDrug
75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Radical Non-Small Cell Lung Cancer (NSCLC) surgeryProcedure or surgery
All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.

Study groups in NCT00191308
Study group	Role	What they receive
Pemetrexed + Cisplatin	Experimental	Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs Receives: Drug: pemetrexed; Drug: cisplatin; Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery

What is being measured

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

High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.
Measured: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)

Secondary outcomes (4)

Percentage of Participants With Objective Tumor Response (Response Rate)
Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.
Measured: Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)
Duration of Response
The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.
Measured: Time of response to disease progression (up to 44.4 months)
Disease Free Survival (DFS)
DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.
Measured: Treatment start to disease progression or death from any cause (up to 45.5 months)
Overall Survival (OS)
OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.
Measured: Treatment start to death from any cause (up to 47.6 months)

Timeline

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

May 2005Dec 2010

First posted19 Sep 2005 (estimated)
Study startMay 2005
Primary completionJul 2008
Study completionDec 2010

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00191308
Sponsor's protocol ID: 9356
Other IDs: H3E-PL-S051
Status last verified: Oct 2011
First submitted: 12 Sep 2005
Last updated: 21 Oct 2011
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 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy
ClinicalTrials.gov ID: NCT00191308
Acronym / sponsor ID: 9356
Conditions: Non-Small Cell Lung Cancer, Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Jul 2008 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 20 Apr 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pemetrexed + Cisplatin	Experimental	Drug: pemetrexed, Drug: cisplatin, Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgeryPemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs

Who may qualify

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

Key inclusion criteria (5 listed)

pathologic documentation of non-small cell lung cancer (NSCLC)
tumor must be accessible by bronchoscopy for tumor tissue sample collection
patients must have lung cancer with clinical stage IB, II, IIIA
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)

Key exclusion criteria (5 listed)

bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
pregnant or breast feeding patients
patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
unwillingness to take folic acid or vitamin B12 supplementation

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/m^2 IV q 21 days for 3 cycles unless disease progression occurs	Drug	Pemetrexed + Cisplatin
cisplatin75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs	Drug	Pemetrexed + Cisplatin
Radical Non-Small Cell Lung Cancer (NSCLC) surgeryAll participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.	Procedure or surgery	Pemetrexed + Cisplatin

Primary outcome

High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Time frame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)
Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.

4 secondary outcomes

Percentage of Participants With Objective Tumor Response (Response Rate)
Time frame: Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)
Duration of Response
Time frame: Time of response to disease progression (up to 44.4 months)
Disease Free Survival (DFS)
Time frame: Treatment start to disease progression or death from any cause (up to 45.5 months)
Overall Survival (OS)
Time frame: Treatment start to death from any cause (up to 47.6 months)

Results and safety

Results posted to the registry on 20 Apr 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	30	29

Primary outcome: High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood

Time frame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed). Number. Unit: participants

Population analysed: Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted.

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	4 of 30 (13.3%)	19 of 30 (63.3%)	Not reported

Limitations and caveats (from the sponsor): Trial enrollment was terminated early due to lack of eligible participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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)
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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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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)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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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
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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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland. 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 20 Apr 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?

High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood (time frame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)). 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 NCT00191308.

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 21 Oct 2011.