Phase 2
Completed N=90
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
Advanced Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT01101334 ↗
Enrolled (actual)
90
Serious AEs
44.9%
Results posted
Jun 2020
Primary outcomePrimary: 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 — 4.1; 3.0 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4.1; 3.0 | — |
| SECONDARY Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy |
7.6; 11.4 | — |
| SECONDARY Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy |
9; 9 | — |
| SECONDARY Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy |
44; 43; 18; 4; 16; 3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01101334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.