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NCT04619797 · ClinicalTrials.gov registry record · Phase 2
A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 542
- Enrollment target
NCT04619797: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT04619797 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 542 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (308% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04619797, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 542 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: * Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin * Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).
Primary Outcome
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstra
Interventions
- DRUG Carboplatin
- DRUG Atezolizumab
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Tiragolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 542 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2025-11-20 |
| Phase | Phase 2 |
What the finished NCT04619797 record still lists
NCT04619797 is an interventional study that assigns participants to a tested intervention. The registered 542 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (308% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT04619797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04619797 about?
NCT04619797 is a clinical study titled "A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer". The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participa...
What is the current status of trial NCT04619797?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 542 participants. The study started on 2020-12-15. Estimated completion is 2025-11-20.
What interventions are being tested in trial NCT04619797?
The interventions under investigation include: Carboplatin (DRUG), Atezolizumab (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Tiragolumab (DRUG).
Who is sponsoring clinical trial NCT04619797?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04619797's enrollment target sits among peer trials
542 62nd of 2000 higher than 1,939 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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