Ramucirumab and Atezolizumab After Progression on Any Immune Checkpoint Blocker in NSCLC

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03689855
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramucirumab — DRUG
    Ramucirumab is an investigational agent for this trial and will be supplied by Lilly Oncology, free of charge to the patient.
  • Atezolizumab — DRUG
    The initial dose will be administered over 60 minutes (+/- 15 minutes). If the first infusion is tolerated without infusion-associated events, the second infusion may be delivered over 30 minutes (+/- 10 minutes).
  • Peripheral blood draw — PROCEDURE
    -Baseline and Cycle 2 Day 1
  • Biopsy — PROCEDURE
    * If archival biopsy tissue not available, participant will undergo biopsy at baseline * When feasible, a repeated tumor biopsy will be obtained between Cycles 2 and 3 after the scheduled CT scan.

Study Details

Data suggests that combining ramucirumab with immunotherapy in non-small cell lung cancer (NSCLC) patients who have previously received immune checkpoint blockers (ICBs) may be more effective than traditional therapy. The investigators propose a pilot study to test the combination of ramucirumab and atezolizumab in patients with advanced-stage NSCLC patients previously treated with ICB.

Key Dates

Start date
Jun 5, 2019
Status verified
Jul 2024
Primary completion
Jul 16, 2021
Completion
Apr 22, 2024

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ramucirumab + Atezolizumab
    * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: At 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Washington University School of Medicine· St Louis, MO

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