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NCT03520686 · ClinicalTrials.gov registry record · Phase 3
Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by ImmunityBio.
- Active
- Registry status
- Phase 3
- Development phase
- 1,538
- Enrollment target
- 20
- Study locations
NCT03520686: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by ImmunityBio.
NCT03520686 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by ImmunityBio. The registered enrollment target is 1,538 participants, above the 649-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (137% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03520686, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by ImmunityBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,538 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.
Primary Outcome
Defined by RECIST Version 1.1 based on BICR
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG NAI + Pembrolizumab
- DRUG NAI + Nivolumab + Ipilimumab
- DRUG NAI + Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel
- DRUG Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel (Investigator's choice)
Study Locations (20)
California
- Chan Soon-Shiong Institute for Medicine - El Segundo
- Adventist Health Glendale - Glendale
- MemorialCare Health System - Long Beach
- Adventist Health White Memorial - Los Angeles
- Hoag Memorial Hospital - Newport Beach
- Desert Hematology Oncology Medical Group - Rancho Mirage
Florida
- Memorial Healthcare - Hollywood
- Baptist Health South Florida - Miami Cancer Institute - Miami
Kentucky
- Baptist Health - Lexington - Lexington
- Baptist Health Louisville - Louisville
New York
- University of Rochester - Rochester
- Stony Brooke Medicine - Stony Brook
Alaska
- Alaska Urological Institute - Alaska Clinical Research Center - Anchorage
Arkansas
- Genesis Cancer Center - Hot Springs
Illinois
- Healthcare Research Network - Tinley Park
Michigan
- Karmanos Cancer Center - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,538 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03520686 still lists
NCT03520686 is an interventional study that assigns participants to a tested intervention. Its 1,538 participants enrollment target places it among the larger protocols in the corpus, above the 649-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (137% higher).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03520686 names 20 study sites across 12 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT03520686 about?
NCT03520686 is a clinical study titled "Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer". This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately. Treatment will continue for up to 2 years, or until the patient experiences confirmed p...
What is the current status of trial NCT03520686?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,538 participants. The study started on 2018-05-18. Estimated completion is 2026-12-31.
What conditions does trial NCT03520686 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT03520686?
The interventions under investigation include: Pembrolizumab (DRUG), NAI + Pembrolizumab (DRUG), NAI + Nivolumab + Ipilimumab (DRUG), NAI + Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel (DRUG), Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel (Investigator's choice) (DRUG).
Who is sponsoring clinical trial NCT03520686?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03520686 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03520686's enrollment target sits among peer trials
1,538 10th of 454 higher than 445 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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