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A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
 
Region Sponsors
Mid-Atlantic
National Cancer Institute (NCI)
Southwest Oncology Group (SWOG)
 
Acronym KP IRB No.
1877939
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Patients with a history of NSCLC with a resistance to prior anti-PD-(L)1 therapy
 
Purpose
The purpose of this study is to see if combining two drugs that work with the immune system can help fight cancer more effectively.
 
Detailed Description
This is a phase II/III clinical trial comparing treatment with N-803 (an interleukin-15 superagonist) plus Pembrolizumab versus standard of care treatments for patients with stage IV non-small cell lung cancer who have already been treated with Anti-PD-1 or Anti-PD-L1 therapy and experienced disease progression post-treatment. The standard of care treatment in this trial is one of the following treatments: docetaxel, gemcitabine, pemetrexed, or ramucirumab plus docetaxel. The primary objective of this study is to compare overall survival of patients randomized to each treatment arm and cohort.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol.
  • Progression following the most recent line of therapy for NSCLC.
  • This therapy must have been exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (Stage IV or recurrent, or Stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy.
 
Exclusion Criteria
  • History of immune-related adverse events or toxicity that led to discontinuation of anti-PD-1/PD-L1 therapy
  • History of organ transplant requiring immunosuppressives
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
  • Any known allergy or reaction to any component of the investigational formulations
  • Any grade III/IV cardiac disease as defined by the New York Heart Association Criteria
  • Any active or uncontrolled disease.

 
Keywords and/or Specific Medical Conditions
  • NSCLC
  • Oncology (Adult)
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, MS
-Gaithersburg Medical Center


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