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

Sponsor
Hoffmann-La Roche
Study ID
NCT04222972
Phase
PHASE3
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pralsetinib — DRUG
    Administered orally
  • Carboplatin — DRUG
    Administered IV
  • Cisplatin — DRUG
    Administered IV
  • Pemetrexed — DRUG
    Administered IV
  • Pembrolizumab — DRUG
    Administered IV
  • Gemcitabine — DRUG
    Administered IV
  • Paclitaxel — DRUG
    Administered IV
  • Nab-Paclitaxel — DRUG
    Administered IV

Study Details

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.

Key Dates

Start date
Jul 24, 2020
Status verified
Feb 2026
Primary completion
Jan 27, 2025
Completion
Jan 27, 2025

Study Design

Enrollment
223 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pralsetinib
    Participants randomized to the Experimental Arm will receive Pralsetinib
  • Active Comparator: Platinum-based chemotherapy with or without pembrolizumab
    Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology) Nonsquamous histology * Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance. * Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance. Squamous histology * Carboplatin or cisplatin / gemcitabine * Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab

Primary Outcome Measure

Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS) [ Time Frame: Up to approximately 50 months ]

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