Small Cell Lung CancerPhase 3NCT00043927

Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

A Phase 3 study testing topotecan/cisplatin and etoposide/cisplatin in people with Small Cell Lung Cancer, run by GlaxoSmithKline at 176 sites in 34 countries.

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

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Small Cell Lung Cancer
What is being tested?: topotecan/cisplatin and etoposide/cisplatin
How many people: 760 participants
Where: 176 sitesin 34 countries
Study dates: Apr 2001to Jan 2004
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

Who may be able to join

Written informed consent (patient's written understanding of and agreement to participate in this study).
Patients with confirmed extensive small cell lung cancer (SCLC).
No prior chemotherapy within 5 years of the diagnosis of SCLC.
Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Who cannot join

Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
Any active infection.
Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
Use of an investigational drug within 30 days before the first dose of study medication.
Women who are pregnant or lactating.

Show all 9Show fewer

Patients of child-bearing potential who refuse to practice an adequate form of birth control.
Patients with clinical evidence of any stomach or intestinal (GI) condition.
Patients requiring treatment with the drug cyclosporin A.

Trial locations and contacts

176 sites in 34 countries.

Country

City, postcode or hospital

176 sites in 34 countries

United States66 sites

GSK Clinical Trials Call Center
Abingdon, Virginia, 24211
GSK Clinical Trials Call Center
Albany, New York, 12208
GSK Clinical Trials Call Center
Albuquerque, New Mexico, 87109
GSK Clinical Trials Call Center
Atlanta, Georgia, 30030
GSK Clinical Trials Call Center
Atlanta, Georgia, 30308
GSK Clinical Trials Call Center
Atlanta, Georgia, 30328
GSK Clinical Trials Call Center
Atlanta, Georgia, 30335
GSK Clinical Trials Call Center
Augusta, Georgia, 30912
GSK Clinical Trials Call Center
Aurora, Illinois, 60506
GSK Clinical Trials Call Center
Bismarck, North Dakota, 58501
GSK Clinical Trials Call Center
Chicago, Illinois, 60612
GSK Clinical Trials Call Center
Chicago, Illinois, 60637-1470
GSK Clinical Trials Call Center
Chula Vista, California, 91911
GSK Clinical Trials Call Center
Cleveland, Ohio, 44106-5065
GSK Clinical Trials Call Center
Colorado Springs, Colorado, 80909
GSK Clinical Trials Call Center
Columbia, South Carolina, 29203
GSK Clinical Trials Call Center
Columbus, Ohio, 43222
GSK Clinical Trials Call Center
Cumming, Georgia, 30040
GSK Clinical Trials Call Center
Decatur, Georgia, 30033
GSK Clinical Trials Call Center
Elk Grove Village, Illinois, 60007
GSK Clinical Trials Call Center
Evansville, Indiana, 47713
GSK Clinical Trials Call Center
Fort Worth, Texas, 76104
GSK Clinical Trials Call Center
Fountain Valley, California, 92708
GSK Clinical Trials Call Center
Frederick, Maryland, 21701
GSK Clinical Trials Call Center
Gainesville, Florida, 32610
GSK Clinical Trials Call Center
Greenbrae, California, 94904
GSK Clinical Trials Call Center
Hoover, Alabama, 35216
GSK Clinical Trials Call Center
Houston, Texas, 77060
GSK Clinical Trials Call Center
Laramie, Wyoming, 82070
GSK Clinical Trials Call Center
Lemoyne, Pennsylvania, 17043
GSK Clinical Trials Call Center
Limerick, Pennsylvania, 19468
GSK Clinical Trials Call Center
Madison, Wisconsin, 53792
GSK Clinical Trials Call Center
Memphis, Tennessee, 38119
GSK Clinical Trials Call Center
Miami Shores, Florida, 33138
GSK Clinical Trials Call Center
Minneapolis, Minnesota, 55404
GSK Clinical Trials Call Center
Morgantown, West Virginia, 26506
GSK Clinical Trials Call Center
New Orleans, Louisiana, 70112
GSK Clinical Trials Call Center
New York, New York, 10021
GSK Clinical Trials Call Center
New York, New York, 10032
GSK Clinical Trials Call Center
Norfolk, Virginia, 23502
GSK Clinical Trials Call Center
Norwich, Connecticut, 06360
GSK Clinical Trials Call Center
Ocala, Florida, 34471
GSK Clinical Trials Call Center
Olympia, Washington, 98506
GSK Clinical Trials Call Center
Park Ridge, Illinois, 60068
GSK Clinical Trials Call Center
Pensacola, Florida, 32501
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, 19140
GSK Clinical Trials Call Center
Pittsfield, Massachusetts, 01201
GSK Clinical Trials Call Center
Portland, Oregon, 97232-2099
GSK Clinical Trials Call Center
Poway, California, 92064
GSK Clinical Trials Call Center
Rancho Mirage, California, 92270
GSK Clinical Trials Call Center
Reno, Nevada, 89502
GSK Clinical Trials Call Center
Rochester, New York, 14623
GSK Clinical Trials Call Center
Sacramento, California, 95816-5616
GSK Clinical Trials Call Center
San Diego, California, 92102-8421
GSK Clinical Trials Call Center
San Diego, California, 92121
GSK Clinical Trials Call Center
Shreveport, Louisiana, 71103
GSK Clinical Trials Call Center
Soquel, California, 95073
GSK Clinical Trials Call Center
South Bend, Indiana, 46601
GSK Clinical Trials Call Center
Spartanburg, South Carolina, 29303
GSK Clinical Trials Call Center
St Louis, Missouri, 63141
GSK Clinical Trials Call Center
Tarpon Springs, Florida, 34689
GSK Clinical Trials Call Center
Valhalla, New York, 10595
GSK Clinical Trials Call Center
Vista, California, 92083
GSK Clinical Trials Call Center
Voorhees Township, New Jersey, 08043
GSK Clinical Trials Call Center
Washington D.C., District of Columbia, 20307-5001
GSK Clinical Trials Call Center
Yakima, Washington, 98902

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Canada17 sites

GSK Clinical Trials Call Center
Calgary, Alberta, T2N 4N2
GSK Clinical Trials Call Center
Edmonton, Alberta, T6G 1E2
GSK Clinical Trials Call Center
Greenfield Park, Quebec, J4V 2H1
GSK Clinical Trials Call Center
Montreal, Quebec, H1T 2M4
GSK Clinical Trials Call Center
Montreal, Quebec, H2L 4M1
GSK Clinical Trials Call Center
Montreal, Quebec, H3T 1E2
GSK Clinical Trials Call Center
Newmarket, Ontario, L3Y 2P9
GSK Clinical Trials Call Center
Oshawa, Ontario, L1G 2B9
GSK Clinical Trials Call Center
Ottawa, Ontario, K1H 1C4
GSK Clinical Trials Call Center
Peterborough, Ontario, K9H 7B6
GSK Clinical Trials Call Center
Sainte-Foy, Quebec, G1V 4G5
GSK Clinical Trials Call Center
Sault Ste. Marie, Ontario, P6B 1Y5
GSK Clinical Trials Call Center
Sydney, Nova Scotia, B1P 1P3
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Thunder Bay, Ontario, P7B 6V4
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Toronto, Ontario, M5G 2M9
GSK Clinical Trials Call Center
Weston, Ontario, M9N 1N8
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Winnipeg, Manitoba, R3E 0V9

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Brazil9 sites

GSK Clinical Trials Call Center
Belo Horizonte, 30140-083
GSK Clinical Trials Call Center
Caxias do Sul, 95010-060
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Fortaleza, 60430-230
GSK Clinical Trials Call Center
Porto Alegre, 90020-090
GSK Clinical Trials Call Center
Porto Alegre, 90035-003
GSK Clinical Trials Call Center
Rio de Janeiro, 20230-130
GSK Clinical Trials Call Center
Salvador, 41920-000
GSK Clinical Trials Call Center
São Paulo, 04023-062
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São Paulo, 05403-900

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Belgium6 sites

GSK Clinical Trials Call Center
Charleroi, 6000
GSK Clinical Trials Call Center
Edegem, 2650
GSK Clinical Trials Call Center
Haine-Saint-Paul, 7100
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Leuven, 3000
GSK Clinical Trials Call Center
Liège, 4000
GSK Clinical Trials Call Center
Luxembourg, 1210

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United Kingdom6 sites

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Aberdeen, Aberdeenshire, AB25 2ZD
GSK Clinical Trials Call Center
Glasgow, G4 0SF
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Leeds, LS16 6QB
GSK Clinical Trials Call Center
Leicester, LE1 5WW
GSK Clinical Trials Call Center
Nottingham, Nottinghamshire, NG5 1PB
GSK Clinical Trials Call Center
Poole, BH15 2JB

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Bulgaria5 sites

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Burgas, 8000
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Plovdiv, 4000
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Sofia, 1000/1527
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Sofia, 1156
GSK Clinical Trials Call Center
Varna, 9010

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Czechia5 sites

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Hradec Králové, 500 05
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Olomouc, 775 25
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Pilsen, 305 99
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Prague, 121 00
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Prague, 150 05

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Netherlands5 sites

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Apeldoorn, 7334 DZ
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Arnhem, 6815 AD
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Ede, 6716 RP
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Harderwijk, 3844 DG
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Nieuwegein, 3435 CM

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China4 sites

GSK Clinical Trials Call Center
Beijing, 100036
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Shanghai, 200433
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Wangfujing, 100730
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Xi'an, 710061

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France4 sites

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Caen, 14076
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Calais, 62107
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Strasbourg, 67091
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Vesoul, 70014

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Germany4 sites

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Ebensfeld, Bavaria, 96250
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Gauting, Bavaria, 82131
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Großhansdorf, 22927
GSK Clinical Trials Call Center
Heidelberg, Baden-Wurttemberg, 69126

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Italy4 sites

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Genoa, Liguria, 16132
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Lazio, 149
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Roma, 149
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Roma, 184

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Mexico4 sites

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Chihuahua City, 31000
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Guadalajara, 44280
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Guadalajara, 45170
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Mexico City, 14000

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Slovakia4 sites

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Banská Bystrica, 975 17
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Bratislava, 825 56
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Košice, 041 09
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Nitra, 949 88

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Austria3 sites

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Vienna, State of Vienna, A-1090
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Vienna, State of Vienna, A-1130
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Vienna, State of Vienna, A-1140

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Finland3 sites

GSK Clinical Trials Call Center
Helsinki, 29
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Kangasala, 36280
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Oulu, 90029

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Russia3 sites

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Moscow, 107 055
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Moscow, 115 478
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Moscow Region, 143 423

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Hungary2 sites

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Budapest, 1529
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Hungary, 8900

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Lithuania2 sites

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Kaunas, LT-45434
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Vilnius, LT-08660

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New Zealand2 sites

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Hamilton, 2001
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Wellington South, 6002

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Poland2 sites

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Gdansk, 80-211
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Kielce, 25-640

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South Korea2 sites

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Seoul, 110-744
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Seoul, 120-752

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Spain2 sites

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Lleida, 25198
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Valencia, Valencia, 46009

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Taiwan2 sites

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Taipei, 100
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Taipei, 105

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Chile1 site

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Santiago

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Costa Rica1 site

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San José

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Estonia1 site

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Tallinn, 11619

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Honduras1 site

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Tegucigalpa

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Jamaica1 site

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Kingston

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Norway1 site

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Oslo, 407

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Panama1 site

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Panama City

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Puerto Rico1 site

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Ponce, 716

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Singapore1 site

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Singapore, 119074

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South Africa1 site

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Johannesburg, Gauteng, 2193

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About this study

Official title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

Conditions: Small Cell Lung Cancer
Being tested: topotecan/cisplatin, etoposide/cisplatin
Keywords: Chemotherapy-naive, Small Cell Lung Cancer, SCLC, Extensive disease, ED, topotecan, Hycamtin, oral
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

topotecan/cisplatinDrug
etoposide/cisplatinDrug

What is being measured

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

Overall Survival

Secondary outcomes (1)

response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients

Timeline

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

Apr 2001Jan 2004

First posted16 Aug 2002 (estimated)
Study startApr 2001
Primary completionJan 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: 760 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00043927
Sponsor's protocol ID: 104864-A/389
Status last verified: Aug 2013
First submitted: 14 Aug 2002
Last updated: 21 Aug 2013
Results posted: 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 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)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
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

All Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT00043927
Acronym / sponsor ID: 104864-A/389
Conditions: Small Cell Lung Cancer
Keywords: Chemotherapy-naive, Small Cell Lung Cancer, SCLC, Extensive disease, ED, topotecan, Hycamtin, oral
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 760 participants
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2001
Primary completion: Jan 2004 (actual)
First posted: 16 Aug 2002 (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)

Who may qualify

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

Key inclusion criteria (7 listed)

Written informed consent (patient's written understanding of and agreement to participate in this study).
Patients with confirmed extensive small cell lung cancer (SCLC).
No prior chemotherapy within 5 years of the diagnosis of SCLC.
Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).

Key exclusion criteria (9 listed)

Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
Any active infection.
Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
Use of an investigational drug within 30 days before the first dose of study medication.

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
topotecan/cisplatin	Drug	–
etoposide/cisplatin	Drug	–

Primary outcome

Overall Survival

1 secondary outcome

response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients

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 21 Aug 2013.

Related trials for 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)
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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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RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
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

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.

GSK Clinical Trial, MD study director

GlaxoSmithKline

176 sites in 34 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing topotecan/cisplatin and etoposide/cisplatin in people with Small Cell Lung Cancer, run by GlaxoSmithKline at 176 sites in 34 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 7 inclusion and 9 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 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Canada, Brazil, Belgium, United Kingdom and 29 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?

Overall Survival. 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 NCT00043927.

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 Aug 2013.