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 — DRUGThe 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 — DRUGThe 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone | New York | New York | 10016 | - |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | - |
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