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NCT03647488 · ClinicalTrials.gov registry record · Phase 2
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 8
- Study locations
NCT03647488: Completed Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
NCT03647488 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 18 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03647488, a Phase 2 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.
Primary Outcome
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Capmatinib
- DRUG Spartalizumab
Study Locations (8)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Grenoble
- Novartis Investigative Site - Lille Cédex
- Novartis Investigative Site - Cologne
- Novartis Investigative Site - Tel Aviv
- Novartis Investigative Site - Madrid
Arkansas
- Highlands Oncology Group - Fayetteville
Catalonia
- Novartis Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-12-26 |
| Est. Completion | 2020-09-07 |
| Phase | Phase 2 |
What the finished NCT03647488 record still lists
NCT03647488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT03647488 lists 8 locations in 3 states (Other, Arkansas, Catalonia).
Frequently Asked Questions
What is clinical trial NCT03647488 about?
NCT03647488 is a clinical study titled "Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer". The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangem...
What is the current status of trial NCT03647488?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2018-12-26. Estimated completion is 2020-09-07.
What conditions does trial NCT03647488 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03647488?
The interventions under investigation include: Docetaxel (DRUG), Capmatinib (DRUG), Spartalizumab (DRUG).
Who is sponsoring clinical trial NCT03647488?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03647488 being conducted?
This trial has 8 study locations across Arkansas, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03647488's enrollment target sits among peer trials
18 120th of 130 higher than 9 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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