The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)
This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 31, 2017 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- GlaxoSmithKline
- Interventions being studied
- Drug: topotecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
- Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
- Patients must give written informed consent to participate in the study.
- Patients must be able to take oral medication.
- Patients should be completely recovered from recent surgery.
- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
- Patients must be evaluated by the radiation oncologist prior to study entry.
- Extensive Stage SCLC.
- Women who are pregnant or lactating.
- Use of an investigational drug within 30 days prior to the first dose of study medication.
- Any medically/clinically significant active infection.
- Symptoms of the SCLC spreading to the brain.
- Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.
- Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.
- Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- GSK Investigational SitePhoenix, Arizona
- GSK Investigational SiteLittle Rock, Arkansas
- GSK Investigational SiteBakersfield, California
- GSK Investigational SiteFountain Valley, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteGainesville, Florida
- GSK Investigational SiteIndianapolis, Indiana
- GSK Investigational SiteLexington, Kentucky
- GSK Investigational SiteNew Orleans, Louisiana
- GSK Investigational SiteNew Orleans, Louisiana
- GSK Investigational SiteShreveport, Louisiana
- GSK Investigational SiteScarborough, Maine
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 31, 2017. Always confirm current availability with the study team.