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

Phase 2

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Carboplatin; Drug: Paclitaxel; Drug: Ramucirumab

• Registration Number: NCT04332367
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-08-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin, Taxane And Ramucirumab	Carboplatin	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
Carboplatin, Taxane And Ramucirumab	Paclitaxel	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
Carboplatin, Taxane And Ramucirumab	Ramucirumab	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States