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Targeted pill shows promise for rare lung cancer, but trial stopped early

NCT ID NCT04222972

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested a new drug called pralsetinib against standard chemotherapy for people with a specific type of advanced lung cancer that has a RET gene fusion. The goal was to see if pralsetinib could better delay cancer growth. The trial was terminated early, so full results are not available, but the drug is already approved in some countries for this cancer type.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pralsetinib
What this could lead to
If successful, pralsetinib could offer a more targeted, effective first-line treatment option for people with RET fusion-positive lung cancer, potentially improving how long they live without their cancer growing.
What could go wrong
The trial was terminated early, so results are limited. As a targeted therapy, it may only work in people with the specific RET fusion, and side effects or resistance could still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

223 people

The number who actually took part.

Started

Jul 2020

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Participant has pathologically confirmed, definitively diagnosed, locally advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease. * Participant must have a documented RET-fusion * Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment. * Participant has an ECOG Performance Status of 0 or 1. * Participant should not have received any prior anticancer therapy for metastatic disease. * Participants can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence. * Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B * Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B. * For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception. * For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm. Exclusion criteria: * Participant's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations. * Participant previously received treatment with a selective RET inhibitor. * Participant received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization. * Participant with a history of pneumonitis within the last 12 months. * Participant has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1. * Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma bronchial disorder bronchogenic carcinoma carcinoma germ cell tumor head and neck neoplasm Head and Neck Neoplasms lung disorder lung neoplasm neoplasm neoplasm of thorax Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue nervous system neoplasm non-small cell lung carcinoma respiratory system disorder respiratory tract neoplasm RET fusion positive cancer Thoracic Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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 Respiratory tract disease Respiratory tract neoplasms RET-fusion non small cell lung cancer Thoracic neoplasms

Contacts and locations

Locations

  • ?zmir Medical Point

    Kar?iyaka, 35575, Turkey (Türkiye)

  • A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento

    Verona, Veneto, 37126, Italy

  • AZ. Ospedaliera San Giovanni - Addolorata

    Rome, Lazio, 00184, Italy

  • Adana City Hospital, Medical Oncology

    Adana, 01060, Turkey (Türkiye)

  • Ankara Bilkent City Hospital

    Ankara, 06490, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios-Fachkliniken Muenchen-Gauting

    Gauting, 82131, Germany

  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello

    Pisa, Tuscany, 56124, Italy

  • CHRU Lille Service de Pneumologie et Oncologie Thoracique

    Lille, 59000, France

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091, France

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31100, France

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE, Argentina

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX, United Kingdom

  • Clinica CIMCA

    San José, 10103, Costa Rica

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, LA Coruna, 15006, Spain

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133, Italy

  • Guys & St Thomas Hospital

    London, SE1 9RT, United Kingdom

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Hemato Oncología de Panamá Especializada

    Panama City, 0801, Panama

  • Hopital Bichat Claude Bernard

    Paris, 75018, France

  • Hopital Tenon

    Paris, 75970, France

  • Hopital de Pontchaillou

    Rennes, 35033, France

  • Hosp Clinico Univ Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital A. C. Camargo

    São Paulo, São Paulo, 01509-010, Brazil

  • Hospital Britanico

    Buenos Aires, C1280AEB, Argentina

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Hôpital Ambroise Paré - Boulogne-Billancourt

    Boulogne-Billancourt, 92100, France

  • Hôpital Louis Pradel, Hospices Civils de Lyon

    Bron, 69677, France

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRCCS Giovanni Paolo II Istituto Oncologico

    Bari, Apulia, 70124, Italy

  • Ico Rene Gauducheau

    Saint-Herblain, 44805, France

  • Insititut Catala D'Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Institut Bergonie CLCC Bordeaux

    Bordeaux, 33000, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141, Italy

  • Istituto Nazionale Tumori Regina Elena

    Rome, Lazio, 00144, Italy

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131, Italy

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kansai Medical University Hospital

    Osaka, 573-1191, Japan

  • Karolinska Universitetssjukhuset, Solna

    Stockholm, 171 76, Sweden

  • Klinik Schillerhöhe

    Stuttgart, 70376, Germany

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Leopoldina-Krankenhaus Medizinische Klinik II

    Schweinfurt, 97422, Germany

  • Maastricht University Medical Center

    Maastricht, 6229 HX, Netherlands

  • NKI/AvL

    Amsterdam, 1066 CX, Netherlands

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

    Warsaw, 02-781, Poland

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520, Japan

  • National Hospital Organization Yamaguchi - Ube Medical Center

    Yamaguchi, 755-0241, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Oslo universitetssykehus HF, Ullevål, Kreftsenteret

    Oslo, 0450, Norway

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100, Italy

  • Ospedale Provinciale Santa Maria Delle Croci

    Ravenna, Emilia-Romagna, 48100, Italy

  • Pius-Hospital

    Oldenburg, 26121, Germany

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • St. James Hospital

    Dublin, D08 HNY1, Ireland

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

  • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13

    Dresden, 01307, Germany

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

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Other studies related to the condition(s) this trial covers.