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NCT01846416 · ClinicalTrials.gov registry record · Phase 2
A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT01846416: Completed Phase 2 study, sponsored by Genentech.
NCT01846416 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01846416, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression. Eligible participants will be categorized in to three groups as follows: 1. Participants with no prior chemotherapy for advanced disease; 2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants); 3. Participants who are 2L+ and previously treated for brain metastases.
Primary Outcome
Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion \[TL\] and non-target lesion \[non-TL\]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least
Interventions
- DRUG Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2013-05-30 |
| Est. Completion | 2017-12-18 |
| Phase | Phase 2 |
What the finished NCT01846416 record still lists
NCT01846416 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody is the first listed.
NCT01846416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01846416 about?
NCT01846416 is a clinical study titled "A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]". This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles...
What is the current status of trial NCT01846416?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2013-05-30. Estimated completion is 2017-12-18.
What interventions are being tested in trial NCT01846416?
The interventions under investigation include: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody (DRUG).
Who is sponsoring clinical trial NCT01846416?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01846416's enrollment target sits among peer trials
138 525th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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