Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2017 |
| Start Date: | September 2010 |
| End Date: | November 23, 2013 |
Randomized, Placebo-controlled, Double-blind Phase 1b/2 Study of U3 1287 (AMG 888) in Combination With Erlotinib in EGFR Treatment Naïve Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Chemotherapy
This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving.
Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding
U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who
fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they
are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287.
The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve
survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding
U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who
fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they
are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287.
The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve
survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
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.
- ≥ 18 years of age.
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Agreement to use effective contraception while on treatment and for at least 6 months
after end of treatment.
Exclusion Criteria:
- Treatment with anticancer therapy, antibody based therapy, retinoid therapy, or
hormonal therapy within 4 weeks before study treatment.
- Left ventricular ejection fraction (LVEF) < 45%.
- Therapeutic radiation or major surgery within 4 weeks before study treatment or
palliative radiation therapy within 2 weeks before study drug treatment.
- Previous use of EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy.
- More than 2 prior chemotherapy regimens for NSCLC (Phase 2 subjects only).
- 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.
- Clinically active brain metastases.
We found this trial at
15
sites
Scottsdale, Arizona 85258
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials