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NCT03456063 · ClinicalTrials.gov registry record · Phase 3
A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
A Phase 3 study of Non-Small Cell Lung, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT03456063: Completed Phase 3 study of Non-Small Cell Lung, sponsored by Hoffmann-La Roche.
NCT03456063 is a Phase 3 study of Non-Small Cell Lung that has completed, run by Hoffmann-La Roche. The registered enrollment target is 453 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03456063, a Phase 3 study of Non-Small Cell Lung, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.
Primary Outcome
IRF-assessed EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, or death from any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Nab-paclitaxel
- DRUG Placebo Comparator
- DRUG Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Study Locations (20)
California
- USC Norris Cancer Center - Los Angeles
- The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange - Orange
- UC Davis Cancer Center - Sacramento
- Scripps Clinic - San Diego
Michigan
- University of Michigan - Ann Arbor
- Brighton Center for Specialty Care - Brighton
- Barbara Ann Karmanos Cancer Institute - Detroit
Colorado
- National Jewish Health - Denver
- Rocky Mountain Cancer Center - Denver
District of Columbia
- Georgetown University - Washington D.C.
- Washington Cancer Institute - Washington D.C.
Minnesota
- Minnesota Oncology Minneapolis - Minneapolis
- Mayo Clinic - Rochester - Rochester
New York
- Northwell Health - Lake Success
- NYU Winthrop Hospital - Mineola
Arizona
- Arizona Oncology - Tucson
Illinois
- Illinois Cancer Care - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the finished NCT03456063 record still lists
NCT03456063 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03456063 names 20 study sites across 11 states, led by California, Michigan, Colorado.
Frequently Asked Questions
What is clinical trial NCT03456063 about?
NCT03456063 is a clinical study titled "A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)". This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB ...
What is the current status of trial NCT03456063?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2018-04-24. Estimated completion is 2025-12-31.
What conditions does trial NCT03456063 study?
This clinical trial studies the following conditions: Non-Small Cell Lung.
What interventions are being tested in trial NCT03456063?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Nab-paclitaxel (DRUG), Placebo Comparator (DRUG), Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody (DRUG).
Who is sponsoring clinical trial NCT03456063?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03456063 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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453 834th of 2000 higher than 1,166 of 2,000 other Phase 3 trials
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