Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance

Study Overview
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Brief Summary
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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.

Official Title
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Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And/Or Pembrolizumab

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Paclitaxel
* Drug: Ramucirumab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin, Taxane And Ramucirumab<br>Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks | Drug: Carboplatin<br>* Carboplatin IV<br>* Other names: Paraplatin;Drug: Paclitaxel<br>* Paclitaxel IV<br>* Other names: Abraxane, Taxol;Drug: Ramucirumab<br>* Ramucirumab IV<br>* Other names: Cyramza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years | 
| 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. | from the first dose of study drug until death, last observation or contact, an average of 1-2 years | 
| 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. | Initiation through 30 days following the last administration of study treatment. |