SWOG, S1800E, PhII/III, Randomized, Doetaxel + Ramucirumab +/- Cemiplimab, NSCLC

What is the Purpose of this Study?

Primary Objective: The primary objective of the study is to compare overall survival (OS) between participants randomized to docetaxel and ramucirumab with or without cemiplimab (REGN2810) who have acquired resistance to platinum-based chemotherapy and immunotherapy for Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). Secondary Objectives: A. To compare investigator-assessed progression-free survival (PFS) per RECIST 1.1 between the arms. B. To compare investigator-assessed response rates (confirmed or unconfirmed, complete response (CR) or partial response (PR)) per RECIST 1.1 between the arms among participants with measurable disease. C. To compare the investigator-assessed disease control rate (confirmed or unconfirmed, complete response (CR), or partial response (PR), and stable disease) between the arms. D. To evaluate the duration of response (DoR) among responders within each arm. E. To evaluate the frequency and severity of toxicities within each arm. F. To compare investigator-assessed PFS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD- L1 subgroups defined as PD-L1 negative (<1% TPS), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>=50% TPS). G. To compare OS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (<1% TPS), intermediate PD-L1 (1-49% TPS), and PD- L1 high (>=50% TPS).


Eligibility

  • * Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol
  • * Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
  • * Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
  • * Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:
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Where can I participate?

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


More about this Clinical Trial

What is the full name of this clinical trial?

S1800E: A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab for Participants Previously Treated with Platinum-based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Study Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Co-Investigators

Amin Mirhadi, Andrew Horodner, Ani Balmanoukian, Benjamin King, David Chan, David Hoffman, Hugo Hool, Jeremy Lorber, Johnny Chang, Justin Wayne Tiulim, Kamya Sankar, Kevin Scher, Marc Botnick, Natasha Banerjee, Navid Hafez, Robert Reznik, Ryan Ponec, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

II/III

IRB Number

STUDY00004265

ClinicalTrials.gov ID

NCT06616584

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Garrett Crook

Email
Garrett.Crook@cshs.org
Study Detail
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

II/III

IRB Number

S1800E

ClinicalTrials.gov ID

NCT06616584

Key Eligibility
ClinicalTrials.gov

Contact
Name

Garrett Crook

Email
Garrett.Crook@cshs.org