The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.
Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two.
PS 0-1
Presence of a driver mutation that is susceptible to targeted therapy
Other active invasive malignancy requiring ongoing therapy
Grade 2 or higher sensory neuropathy
Evidence of untreated brain metastases
Single group
Carboplatin
DrugCarboplatin IV
Paclitaxel
DrugPaclitaxel IV
Ramucirumab
DrugRamucirumab IV
To estimate overall response rate
Overall response rate (ORR) as determined by RECIST criteria. Response will be defined by a complete response (CR) or partial response (PRO), confirmed or unconfirmed.
Progression-free survival
Progression-free survival (PFS) defined as the duration from the first study dose of study drug until progressive disease, death or last assessment contact whichever comes first.
Overall Survival
Overall Survival (OS) is defined as the time from the first dose of study drug until death due to any cause or last observation or contact.
Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0
Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0.
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