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NCT05633667 · ClinicalTrials.gov registry record · Phase 2
Study of Novel Treatment Combinations in Patients With Lung Cancer
A Phase 2 study of Lung Cancer and Advanced or Metastatic Non-Small-Cell Lung Cancer, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
- 20
- Study locations
NCT05633667: Recruiting Phase 2 study of Lung Cancer and Advanced or Metastatic Non-Small-Cell Lung Cancer, sponsored by Gilead Sciences.
NCT05633667 is a Phase 2 study of Lung Cancer and Advanced or Metastatic Non-Small-Cell Lung Cancer that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 270 participants, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05633667, a Phase 2 study of Lung Cancer and Advanced or Metastatic Non-Small-Cell Lung Cancer, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
Primary Outcome
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Zimberelimab (ZIM)
- DRUG Domvanalimab (DOM)
- DRUG Sacituzumab govitecan-hziy (SG)
- DRUG Etrumadenant (ETRUMA)
Study Locations (20)
Missouri
- Washington University School of Medicine - Siteman Cancer Center,Substudy-01 - St Louis
- Washington University School of Medicine - Siteman Cancer Center,Substudy-02 - St Louis
- Washington University School of Medicine - Siteman Cancer Center,Substudy-03 - St Louis
- Washington University School of Medicine - Siteman Cancer Center - St Louis
Arizona
- Arizona Oncology Associates,Substudy-01 - Tucson
- Arizona Oncology Associates,Substudy-02 - Tucson
Colorado
- Rocky Mountain Cancer Center,Substudy-01 - Denver
- Rocky Mountain Cancer Center,Substudy-02 - Denver
Ohio
- Oncology Hematology Care Clinical Trials, LLC,Substudy-01 - Cincinnati
- Oncology Hematology Care Clinical Trials, LLC,Substudy-02 - Cincinnati
Oregon
- Oncology Associates of Oregon, PC,Substudy-01 - Eugene
- Oncology Associates of Oregon, PC,Substudy-02 - Eugene
Texas
- Texas Oncology - Central South,Substudy-01 - Austin
- Texas Oncology - Central South,Substudy-02 - Austin
Virginia
- US Oncology Investigational Products Center (IPC),Substudy-01 - Fairfax
- US Oncology Investigational Products Center (IPC),Substudy-02 - Fairfax
Washington
- Fred Hutchinson Cancer Center,Substudy-01 - Seattle
- Fred Hutchinson Cancer Center,Substudy-02 - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2029-09 |
| Phase | Phase 2 |
What NCT05633667 shows while recruiting
NCT05633667 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05633667 names 20 study sites across 10 states, led by Missouri, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT05633667 about?
NCT05633667 is a clinical study titled "Study of Novel Treatment Combinations in Patients With Lung Cancer". The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCL...
What is the current status of trial NCT05633667?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2023-03-16. Estimated completion is 2029-09.
What conditions does trial NCT05633667 study?
This clinical trial studies the following conditions: Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer.
What interventions are being tested in trial NCT05633667?
The interventions under investigation include: Carboplatin (DRUG), Zimberelimab (ZIM) (DRUG), Domvanalimab (DOM) (DRUG), Sacituzumab govitecan-hziy (SG) (DRUG), Etrumadenant (ETRUMA) (DRUG).
Who is sponsoring clinical trial NCT05633667?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05633667 being conducted?
This trial has 20 study locations across Arizona, Colorado, Indiana, Kentucky, Missouri. 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 NCT05633667's enrollment target sits among peer trials
270 110th of 409 higher than 300 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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