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NCT04340882 · ClinicalTrials.gov registry record · Phase 2
Phase 2 DoceRamPem for Patients With Metastatic or Recurrent NSCLC Who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT04340882: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by Emory University.
NCT04340882 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8 that is active but no longer recruiting, run by Emory University. The registered enrollment target is 30 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04340882, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase 2 trial will evaluate the safety and efficacy of combining immunotherapy with a PD-1 checkpoint inhibitor (Pembrolizumab), an anti-VEGF receptor (Ramucirumab), and a taxane chemotherapy (Docetaxel) in treating patients with non-small cell lung cancer (NSCLC) who did not respond to FDA-approved treatments with platinum-based chemotherapy given concurrently or sequentially with anti-PD1/PD-L1 immunotherapy. Pembrolizumab helps the body's immune system to attack cancer cells and hinder their ability to grow and spread. Ramucirumab blocks new blood vessel growth to reduce tumor growth. Docetaxel works mainly by stopping cancer cells from dividing. Ramucirumab combined with docetaxel is an FDA-approved therapy for NSCLC patients after progression on platinum-based chemotherapy. It has shown to improve efficacy compared to docetaxel alone in this setting. Pembrolizumab is an FDA-approved treatment for NSCLC and can be given alone or in combination with platinum-based chemotherapy. Investigators hypothesize that the combination of docetaxel, ramucirumab, and pembrolizumab will be safe and more effective than the current standard of care treatments (docetaxel alone or in combination with ramucirumab) in patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and immunotherapy, given concurrently or sequentially.
Primary Outcome
Will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be reported and its 95% confidence intervals will be estimated using the Clopper-Pearson method. PFS rates of two patient groups stratified by binary biomarker (PD-L1 and KRAS status), respectively will be estimated with the Kaplan-Meier method and compared using the log-rank test, respectively. Cox proportional hazards models will be further used in the multivariable analyses to assess adjusted effect of PD-L1
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Docetaxel
- BIOLOGICAL Ramucirumab
Study Locations (2)
Georgia
- Grady Health System - Atlanta
- Winship Cancer Institute of Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-06-05 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04340882 still lists
NCT04340882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (69% lower).
The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04340882 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04340882 about?
NCT04340882 is a clinical study titled "Phase 2 DoceRamPem for Patients With Metastatic or Recurrent NSCLC Who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade". This phase 2 trial will evaluate the safety and efficacy of combining immunotherapy with a PD-1 checkpoint inhibitor (Pembrolizumab), an anti-VEGF receptor (Ramucirumab), and a taxane chemotherapy (Docetaxel) in treating patients with non-small cell lung cancer (NSCLC) who did not respond to FDA-app...
What is the current status of trial NCT04340882?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2020-06-05. Estimated completion is 2030-09-30.
What conditions does trial NCT04340882 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Metastatic Non-Small Lung Cell Cancer, Recurrent Non-Small Lung Cell Cancer.
What interventions are being tested in trial NCT04340882?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Docetaxel (DRUG), Ramucirumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04340882?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04340882 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04340882's enrollment target sits among peer trials
30 48th of 81 higher than 30 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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