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Recruiting

NCT Number: NCT04332367

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

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.

Recruiting

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Melissa Volpe

CONTACT

[email protected]

215-220-9703

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

carboplatin

Drug

Carboplatin IV

Other names: Paraplatin

paclitaxel

Drug

Paclitaxel IV

Other names: Abraxane, Taxol

Ramucirumab

Drug

Ramucirumab IV

Other names: Cyramza

Primary outcomes

  1. To estimate overall response rate

    Time frame: 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 outcomes

  1. Progression-free survival

    Time frame: 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.

  2. Overall Survival

    Time frame: 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.

  3. Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melina Marmarelis, MD

CONTACT

267-438-8154

Melissa Volpe, BA

CONTACT

[email protected]

215-220-9703

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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