TH-189: A Phase 2 Study of Nivolumab plus Ramucirumab in Patients with Recurrent Advanced Metastatic Non-Small Cell Lung Carcinoma

Brief description of study

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 (see Schema). At Fox Chase Cancer Center, we see roughly 10,000 new patients annually, and enroll approximately 700 patients annually on clinical trials, including at least 60 lung cancer patients. This is a multi-center trial with expected 2-3 participating centers. We intend to enroll 39 IO-experienced patients within 8 months (4-5 patients per month). The study will also utilize a Simon’s optimal two-stage design, and the accrual will be terminated early due to futility based upon 19 patients as described in the statistical consideration in section 12.2. Up to 39 evaluable patients will be accrued to this trial.


Clinical Study Identifier: s22-01366
ClinicalTrials.gov Identifier: NCT03527108
Principal Investigator: Vamsidhar Velcheti.
Other Investigators: Samantha VanMaanen, Jessica Wang, Elaine Shum, Salman Rafi Punekar, Sally Lau, Joshua K Sabari, David Mendoza, Melissa L Martinez, Natalia Cherkassky, Kirby Rodriguez.


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