Autopsy report · NCT04222972

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

“Early termination of the study resulted from organizational and commercial decisions that led to the discontinuation of pralsetinib's global marketing and development in all territories (excluding US and Greater China).”

The sponsor’s own words in the registry.

Life of this trial

• Registered 7 months before it started.
• Ran for about 4 years 6 months before it stopped.
• 223 participants enrolled.
• Results were posted on the registry 1 year 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Hoffmann-La Roche

Sponsor type

Industry

Conditions

RET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Interventions

Pralsetinib; Carboplatin; Cisplatin; Pemetrexed; Pembrolizumab; Gemcitabine

Participants

223

Sites

74

Countries

Argentina, Australia, Belgium, Brazil, Costa Rica, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands and more

Trials that died the same way

• A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
  “The study was terminated due to strategic business reasons.” (58% match in meaning)
• Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
  “Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.” (57% match in meaning)
• A Safety Study of PF-08046045/SGN-35T in Adults With Advanced Cancers
  “Study terminated as part of strategic considerations” (55% match in meaning)
• A Study to Test if TEV-53275 is Effective in Relieving Asthma
  “Stopped for strategic reasons” (55% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.