Combining carboplatin, taxane, and ramucirumab for advanced lung cancer treatment
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
This study is testing a new combination of three drugs to see if it can help adults with advanced lung cancer who have already tried other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | Pembrolizumab, ramucirumab |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04332367 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of a combination therapy using carboplatin, paclitaxel, and ramucirumab in patients with advanced non-small cell lung cancer (NSCLC) who have previously undergone treatment with pemetrexed or pembrolizumab. The goal is to determine if this combination can shrink tumors or delay their growth. Participants must be adults aged 18 or older with specific prior treatment histories and performance status. The study aims to provide insights into the potential benefits of this drug combination for managing NSCLC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with advanced non-squamous NSCLC who have previously received specific treatments and have a performance status of 0-1.
Not a fit: Patients with driver mutations susceptible to targeted therapy or those with untreated brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with advanced NSCLC who have limited alternatives.
How similar studies have performed: Other studies have explored similar combinations in lung cancer treatment, showing promising results, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Philadelphia, Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Melina Marmarelis, MD — Abramson Cancer Center at Penn Medicine
- Study coordinator: Melissa Volpe, BA
- Email: Melissa.volpe@pennmedicine.upenn.edu
- Phone: 215-220-9703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.