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

> **NCT04222972** · PHASE3 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 223 (actual)

## Conditions studied

- RET-fusion Non Small Cell Lung Cancer
- Lung Neoplasm
- Carcinoma, Non-Small-Cell Lung
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neoplasms by Site
- Neoplasms
- Lung Diseases
- Respiratory Tract Disease
- Carcinoma, Bronchogenic
- Bronchial Diseases
- Head and Neck Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms by Histologic Type
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue

## Interventions

- **DRUG:** Pralsetinib
- **DRUG:** Carboplatin
- **DRUG:** Cisplatin
- **DRUG:** Pemetrexed
- **DRUG:** Pembrolizumab
- **DRUG:** Gemcitabine
- **DRUG:** Paclitaxel
- **DRUG:** Nab-Paclitaxel

## Key facts

- **NCT ID:** NCT04222972
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-07-24
- **Primary completion:** 2025-01-27
- **Final completion:** 2025-01-27
- **Target enrollment:** 223 (ACTUAL)
- **Why stopped:** 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).
- **Last updated:** 2026-03-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04222972

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04222972, "A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT04222972. Licensed CC0.

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