Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGCarboplatin
Carboplatin IV
DRUGPaclitaxel
Paclitaxel IV
DRUGRamucirumab
Ramucirumab IV
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * History of bleeding diatheses or recent, antecedent hemoptysis (\> 1/2 teaspoon in prior 2 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To estimate overall response rate | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years | 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 | from the first dose of study drug until death, last observation or contact, an average of 1-2 years | 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 | Initiation through 30 days following the last administration of study treatment. | Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0. |
Countries
United States
Contacts
CONTACTMelissa Volpe, BA
CONTACTMelina Marmarelis, MD
PRINCIPAL_INVESTIGATORMelina Marmarelis, MD
Abramson Cancer Center at Penn Medicine
Outcome results
None listed