Non-small Cell Lung Cancer
Conditions
Brief summary
Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called Tavocept. Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.
Interventions
DRUGTavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel
Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Tavocept(BNP7787) 18.4gm/m2 IV every 3 weeks
DRUGPlacebo in combination with cisplatin and docetaxel or paclitaxel
Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Placebo IV every 3 weeks
Sponsors
Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
BioNumerik Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung * No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies or investigational drugs
Exclusion criteria
* Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg, small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or cytological diagnosis of primary lung cancer * Adenocarcinoma arising from primary sites other than the lung * Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging System 7th edition) * Patients with unstable CNS mets within 21 days before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of NCI-CTCAE grade 2,3, or 4 anemia | throughout the study |
| Progression Free Survival | Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment |
| Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline | throughout the study |
| Proportion of patients having no impact of chemotherapy-induced emesis on daily life | throughout the study |
Countries
Bulgaria, Poland, Romania, Russia, Ukraine, United States
Outcome results
None listed