Non Small Cell Lung CancerPhase 2NCT01165021

A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

A Phase 2 study testing Pemetrexed, Cisplatin and Folic Acid in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 7 sites in Italy.

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 purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size. 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 Folic Acid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 7 sitesItaly
Study dates: Nov 2010to Apr 2016
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

Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
Tumor considered potentially resectable
Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
No prior therapy for lung cancer
Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

Show all 12Show fewer

Life expectancy of at least 6 months
Organs are functioning well (bone marrow reserve, liver, kidney, lung)
Signed Informed Consent
Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
Be fit for surgery at the time of enrollment

Who cannot join

Receiving or have received an investigational drug or device within the last 30 days
Have previously completed or withdrawn from this study or any other study investigating pemetrexed
Serious concomitant systemic disorder
Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
Receiving concurrent administration of any other anticancer therapy
Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Italy7 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.
Milan, 20133
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.
Novara, 28100
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.
Orbassano, 10043
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.
Padova, 35100
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.
Pisa, 56100
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.
Rome, 00144
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.
Sondalo, 23039

Other trials in Italy

About this study

Official title: An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Conditions: Non Small Cell Lung Cancer
Being tested: Pemetrexed, Cisplatin, Folic Acid, Vitamin B12, Dexamethasone
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 Alimta, LY231514
500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
CisplatinDrug
75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Folic AcidDrug
Administered orally.
Vitamin B12Drug
Administered Intramuscular injection.
DexamethasoneDrug
Administered orally.

Study groups in NCT01165021
Study group	Role	What they receive
Pemetrexed + Cisplatin	Experimental	Not described Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Folic Acid; Drug: Vitamin B12; Drug: Dexamethasone

What is being measured

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

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
Measured: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy

Secondary outcomes (4)

Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]
pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.
Measured: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)
Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0
Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.
Measured: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
Overall Survival (OS)
OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.
Measured: Enrollment until the date of death from any cause up to 64 months
Progression-Free Survival (PFS)
PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Measured: Enrollment until the first date of objectively determined PD or death up to 64 months

Timeline

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

Nov 2010Apr 2016

First posted19 Jul 2010 (estimated)
Study startNov 2010
Primary completionJul 2013
Study completionApr 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01165021
Sponsor's protocol ID: 13621
Other IDs: H3E-EW-JMIP
Status last verified: Sep 2019
First submitted: 14 Jul 2010
Last updated: 25 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT01165021
Acronym / sponsor ID: 13621
Conditions: Non Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Jul 2013 (actual)
Study completion: Apr 2016 (actual)
First posted: 19 Jul 2010 (estimated)
Results: Posted 21 May 2014

Clinical summary

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

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pemetrexed + Cisplatin	Experimental	Drug: Pemetrexed, Drug: Cisplatin, Drug: Folic Acid, Drug: Vitamin B12, Drug: Dexamethasone

Who may qualify

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

Key inclusion criteria (12 listed)

Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
Tumor considered potentially resectable
Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
No prior therapy for lung cancer

Key exclusion criteria (8 listed)

Receiving or have received an investigational drug or device within the last 30 days
Have previously completed or withdrawn from this study or any other study investigating pemetrexed
Serious concomitant systemic disorder
Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
Receiving concurrent administration of any other anticancer therapy

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: Alimta, LY231514500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles	Drug	Pemetrexed + Cisplatin
Cisplatin75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles	Drug	Pemetrexed + Cisplatin
Folic AcidAdministered orally.	Drug	Pemetrexed + Cisplatin
Vitamin B12Administered Intramuscular injection.	Drug	Pemetrexed + Cisplatin
DexamethasoneAdministered orally.	Drug	Pemetrexed + Cisplatin

Primary outcome

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Time frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

4 secondary outcomes

Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]
Time frame: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)
Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0
Time frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
Overall Survival (OS)
Time frame: Enrollment until the date of death from any cause up to 64 months
Progression-Free Survival (PFS)
Time frame: Enrollment until the first date of objectively determined PD or death up to 64 months

Results and safety

Results posted to the registry on 21 May 2014, 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	19	18

Primary outcome: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

Time frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pemetrexed + Cisplatin n = 17
Value	41.2 (18.4 to 67.1)

Population analysed: Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.

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	2 of 19 (10.5%)	15 of 19 (78.9%)	Not reported

Limitations and caveats (from the sponsor): Due to difficulties identifying suitable participants and enrollment delays, entries were closed after 26 of planned 33 participants signed consent. Results based on 19 participants who received ≥1 dose of chemotherapy. View results with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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
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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
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

7 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 Folic Acid in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 7 sites in Italy.

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 12 inclusion and 8 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. 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 21 May 2014). 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 With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] (time frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy). 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 NCT01165021.

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 25 Sep 2019.