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NCT05096663 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT05096663: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by SWOG Cancer Research Network.
NCT05096663 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8 that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 82 participants, below the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05096663, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.
Primary Outcome
Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Dexamethasone
- DRUG Gemcitabine
- DIETARY_SUPPLEMENT Cobalamin
- DIETARY_SUPPLEMENT Folic Acid
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Kaiser Permanente-Fontana - Fontana
- Palo Alto Medical Foundation-Fremont - Fremont
- Kaiser Permanente - Harbor City - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente West Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Memorial Medical Center - Modesto
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Ontario - Ontario
Alabama
- Veterans Administration Medical Center - Birmingham - Birmingham
Arizona
- CTCA at Western Regional Medical Center - Goodyear
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2022-03-15 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
What the registry record for NCT05096663 still lists
NCT05096663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (15% lower).
The record links to 9 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT05096663 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05096663 about?
NCT05096663 is a clinical study titled "Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)". This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert a...
What is the current status of trial NCT05096663?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2022-03-15. Estimated completion is 2027-12-01.
What conditions does trial NCT05096663 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8.
What interventions are being tested in trial NCT05096663?
The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Cobalamin (DIETARY_SUPPLEMENT), Folic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05096663?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05096663 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05096663's enrollment target sits among peer trials
82 22nd of 81 higher than 60 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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