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NCT03745222 · ClinicalTrials.gov registry record · Phase 3

A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer

A Phase 3 study, sponsored by Celgene.

Terminated
Registry status
Phase 3
Development phase
1
Enrollment target

NCT03745222: Clinical Trial Phase 3 study, sponsored by Celgene.

NCT03745222 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03745222, a Phase 3 study, was terminated before completion, sponsored by Celgene.

TERMINATED
Registry status
Phase 3
Development phase
1 participants
Enrollment target

Study Summary

This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

Primary Outcome

Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to q

Interventions

  • OTHER Placebo
  • DRUG Tislelizumab
  • DRUG Concurrent chemoradiotherapy (cCRT)

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2019-05-22
Est. Completion 2019-06-26
Phase Phase 3
Celgene

308 total trials

Why NCT03745222 stopped before completion

NCT03745222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03745222 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03745222 about?

NCT03745222 is a clinical study titled "A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer". This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially aft...

What is the current status of trial NCT03745222?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2019-05-22. Estimated completion is 2019-06-26.

What interventions are being tested in trial NCT03745222?

The interventions under investigation include: Placebo (OTHER), Tislelizumab (DRUG), Concurrent chemoradiotherapy (cCRT) (DRUG).

Who is sponsoring clinical trial NCT03745222?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03745222's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT03745222, the US trial registry maintained by the National Library of Medicine. NCT03745222 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.