Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 13, 2020 · 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
- Daiichi Sankyo
- Interventions being studied
- Drug: CS7017 tablets; Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo Tablets
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.
- Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
- Age greater than or equal to 18 years
- Adequate organ and bone marrow function
- Any prior systemic therapy for NSCLC
- Major surgical procedure or other investigational agents within 4 weeks before study enrollment
- Need for concomitant use of other thiazolidinediones during the study
- History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction;
- Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University Colorado Cancer CenterAurora, Colorado
- Georgetown Univ. Medical CenterWashington D.C., District of Columbia
- Southern Illinois Hematology/OncologyCentralia, Illinois
- Rush University Medical CenterChicago, Illinois
- Michiana Hematology-OncologySouth Bend, Indiana
- Harbor View Cancer CenterBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Signal Point Clinical Research CenterMiddletown, Ohio
- Penn State Milton Hershey Cancer CenterHershey, Pennsylvania
- Eastern Virginia Medical SchoolNorfolk, Virginia
- Kidwai Memorial Institute of OncologyBangalore, Karnataka
- Pentagon ResearchAundh, Maharashtra
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2020. Always confirm current availability with the study team.