Ramucirumab plus Pembrolizumab Versus Standard of Care for Stage IV or Recurrent Non-Small Cell Lung Cancer

What is the Purpose of this Study?

This study aims to determine whether a new combination of 2 non-chemotherapy drugs can help patients with advanced non-small cell lung cancer to live longer than the usual approach. (The usual approach is defined as treatment with chemotherapy). Researchers will compare the usual treatment to a study treatment that combines ramucirumab and pembrolizumab, which is an experimental combination of drugs. Participants will be randomly assigned to 1 of 2 study groups. One group will receive the study drugs (ramucirumab and pembrolizumab), and the other will receive the usual treatment option (standard-of-care treatment).


Eligibility

  • * Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) which is stage IV or recurrent
  • * Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy
  • * Participants must have experienced disease progression (in the opinion of the treating physician) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 therapy
  • * Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable, partial response or complete response (in the opinion of the treating physician)
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Where can I participate?

  • CS Cancer Tarzana : Amy Oppenheim
  • CS Cancer at Beverly Hills : Amy Oppenheim
  • CS Cancer at Cedars-Sinai Medical Center : Amy Oppenheim
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer


More about this Clinical Trial

What is the full name of this clinical trial?

S2302: PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab Plus Pembrolizumab versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Study Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Co-Investigators

Andrew Hendifar, Andrew Horodner, Ani Balmanoukian, David Chan, Hugo Hool, Jeremy Lorber, Johnny Chang, Kamya Sankar, Kevin Scher, Natasha Banerjee, Ryan Ponec, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

III

IRB Number

STUDY00002664

ClinicalTrials.gov ID

NCT05633602

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Study Detail
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

III

IRB Number

S2302

ClinicalTrials.gov ID

NCT05633602

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org