Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC

Part of paid clinical trials in New York, New York.

Sponsor
Fox Chase Cancer Center
Study ID
NCT03527108
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    The treatment will be given on a 28-day cycle, with doses of nivolumab and ramucirumab given on days 1 and 15. The dose of nivolumab will be fixed at 240 mg. Nivolumab should be administered first, followed by premedication, and then ramucirumab. Ramucirumab should be administered approximately 30 minutes after premedication
  • Ramucirumab — DRUG
    The treatment will be given on a 28-day cycle, with doses of nivolumab and ramucirumab given on days 1 and 15. The dose of ramucirumab will depend upon the patient weight as noted below. Nivolumab should be administered first, followed by premedication, and then ramucirumab. Ramucirumab should be administered approximately 30 minutes after premedication

Study Details

The study will enroll patients with prior IO therapy (alone or in combination with chemotherapy or in combination with other IO agents) regardless of the PD-L1 level, into a non-randomized combination trial, with primary endpoint of disease control rate.

Key Dates

Start date
Oct 8, 2020
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Patients with prior IO therapy

Primary Outcome Measure

Disease control rate (DCR) in IO experienced patients.treated with nivolumab and ramucirumab combination therapy [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
NYU LangoneNew YorkNew York10016-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

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