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

Abramson Cancer Center at Penn Medicine

Status and phase: Enrolling; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Ramucirumab; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04332367

UPCC 05519

IRB833759 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Carboplatin, Taxane And Ramucirumab

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Ramucirumab