Non-Small Cell Lung CancerPhase 3NCT00191126

Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

A Phase 3 study testing gemcitabine, Cisplatin and surgery in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 37 sites in 15 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: gemcitabine, Cisplatin and surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 37 sitesin 15 countries
Study dates: Sep 2000to Sep 2007
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Main inclusion Criteria:

Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
ECOG Performance Status of 0 - 1
Bidimensionally measurable disease or evaluable disease
Adequate organ function

Main exclusion Criteria:

Have greater than Grade 1 neuropathy - motor/sensory
Significant history of cardiac disease
Pleural effusion

Trial locations and contacts

37 sites in 15 countries.

Country

City, postcode or hospital

37 sites in 15 countries

Italy13 sites

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Bologna
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Chieti
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L’Aquila
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Milan
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Naples
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Padova
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Perugia
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Pisa
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Roma
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Siena
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Teramo
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Torino
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Verona

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Germany4 sites

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Großhansdorf
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Löwenstein
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Nuremberg
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Ulm

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Lithuania3 sites

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Kaunas
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Klaipedos
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Vilnius

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Belgium2 sites

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Leuven
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Liège

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Bulgaria2 sites

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Sofia
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Varna

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Romania2 sites

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Bucharest
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Cluj-Napoca

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Slovakia2 sites

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Bratislava
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Košice

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Sweden2 sites

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Helsingborg
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Malmö

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Bosnia and Herzegovina1 site

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Sarajevo

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Egypt1 site

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Cairo

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Estonia1 site

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Tallinn

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Hungary1 site

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Pécs

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Poland1 site

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Warsaw

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Saudi Arabia1 site

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Riyadh

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Taiwan1 site

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Taichung

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About this study

Official title: Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

Conditions: Non-Small Cell Lung Cancer
Being tested: gemcitabine, Cisplatin, surgery
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.

gemcitabineDrug
Also called LY188011, Gemzar
1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
CisplatinDrug
75 mg/m2, IV, q 21 days x 3 cycles
surgeryProcedure or surgery
surgery

Study groups in NCT00191126
Study group	Role	What they receive
A	Other	Not described Receives: Procedure: surgery
B	Experimental	Not described Receives: Drug: gemcitabine; Drug: Cisplatin; Procedure: surgery

What is being measured

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

Progression free survival
Measured: baseline to measure progressive disease

Secondary outcomes (4)

To compare the survival and sites of relapse in the two study arms.
Measured: baseline to progressive disease
Pharmacology toxicity
Measured: every cycle
Response rate
Measured: baseline to measured progressive disease
Pathologic response rate of tissue samples
Measured: baseline, post chemotherapy, post surgery

Timeline

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

Sep 2000Sep 2007

First posted19 Sep 2005 (estimated)
Study startSep 2000
Primary completionSep 2007
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00191126
Sponsor's protocol ID: 3532
Other IDs: B9E-MC-S132
Status last verified: Sep 2019
First submitted: 12 Sep 2005
Last updated: 12 Sep 2019
Results posted: No
Data monitoring committee: Yes
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.

Publications

Scagliotti GV, Pastorino U, Vansteenkiste JF, Spaggiari L, Facciolo F, Orlowski TM, Maiorino L, Hetzel M, Leschinger M, Visseren-Grul C, Torri V. Randomized phase III study of surgery alone or surgery plus preoperative cisplatin and gemcitabine in stages IB to IIIA non-small-cell lung cancer. J Clin Oncol. 2012 Jan 10;30(2):172-8. doi: 10.1200/JCO.2010.33.7089. Epub 2011 Nov 28.
PubMed 22124104

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 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT00191126
Acronym / sponsor ID: 3532
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2000
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 19 Sep 2005 (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.

Study design

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

Arm	Type	Receives
A	Other	Procedure: surgery
B	Experimental	Drug: gemcitabine, Drug: Cisplatin, Procedure: surgery

Who may qualify

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

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
gemcitabineAlso: LY188011, Gemzar1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles	Drug	B
Cisplatin75 mg/m2, IV, q 21 days x 3 cycles	Drug	B
surgerysurgery	Procedure or surgery	A, B

Primary outcome

Progression free survival
Time frame: baseline to measure progressive disease

4 secondary outcomes

To compare the survival and sites of relapse in the two study arms.
Time frame: baseline to progressive disease
Pharmacology toxicity
Time frame: every cycle
Response rate
Time frame: baseline to measured progressive disease
Pathologic response rate of tissue samples
Time frame: baseline, post chemotherapy, post surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
Results publication: PubMed 22124104Scagliotti GV, Pastorino U, Vansteenkiste JF, Spaggiari L, Facciolo F, Orlowski TM, Maiorino L, Hetzel M, Leschinger M, Visseren-Grul C, Torri V. Randomized phase III study of surgery alone or surgery plus preoperative cisplatin and gemcitabine in stages IB to IIIA non-small-cell lung cancer. J Clin Oncol. 2012 Jan 10;30(2):172-8. doi: 10.1200/JCO.2010.33.7089. Epub 2011 Nov 28.
Lilly Clinical Trial RegistryLink provided by the sponsor.
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

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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)
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Active, not recruitingPhase 2
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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
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 chair

Eli Lilly and Company

37 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine, Cisplatin and surgery in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 37 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 12 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 37 sites in Italy, Germany, Lithuania, Belgium, Bulgaria and 10 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression free survival (time frame: baseline to measure progressive disease). 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 NCT00191126, 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 12 Sep 2019.