Clinical trial · Interventional
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
NCT01101334CI-TRIAL-00045548completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study. The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CS-7017 | Drug | — | UNRESOLVED |
| erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CS-7017 plus erlotinib
- interventionNames
- Drug: CS-7017
- Drug: erlotinib
- type
- ACTIVE_COMPARATOR
- label
- erlotinib
- interventionNames
- Drug: erlotinib
Primary outcomes (1)
- measure
- Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
- timeFrame
- Baseline to disease progression or death, up to approximately 2.5 years
- description
- Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage IIIB or IV NSCLC. * Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy. * Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria. * ≥ 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Adequate organ and bone marrow function. * Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade ≤ 1. * Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment. Exclusion Criteria: * Treatment with anticancer therapy within 3 weeks before study treatment. * Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases). * Administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment. * Current need for concomitant use of other TZDs during the study. * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening. * History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting \> 4 weeks), inflammatory bowel disease, or partial bowel obstruction. * Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor. * Pregnant or breast feeding. * Prior treatment with epidermal growth factor receptor (EGFR) inhibitors.
References
Publications (0)
Data not yet available
No reference posted for this study.