A study with Repotrectinib compared to Crizotinib in participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive (TRIDENT-3)
Descrizione riassuntiva dello studio
CA1271030 is a randomized (study participants are assigned to a treatment at random, like flipping a coin), open-label (both participants and the study physician know whether they are receiving the experimental or standard treatment) phase 3 (late-phase) study designed to show that the administered treatment is not worse than the current standard treatment in stopping or slowing ROS1-positive non-small cell lung cancer (NSCLC). Approximately 230 eligible participants will be randomized in a 1:1 ratio to receive either the experimental treatment (Repotrectinib) or Crizotinib. Treatment will continue until disease progression per BICR assessment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), until death occurs, unacceptable toxicity, loss to follow-up, withdrawal of consent, or termination of the study by the sponsor, whichever occurs first.
(BASEC)
Intervento studiato
- One group receives Repotrectinib at a fixed dose on fixed days
- One group receives Crizotinib at a fixed dose on fixed days
(BASEC)
Malattie studiate
Non-small cell lung cancer
(BASEC)
• Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC • Participants with ROS1 gene rearrangement/fusion, demonstrated by local testing • At least one measurable lesion per RECIST v1.1 in the investigator's assessment • Participants must not have been pre-treated with TKIs that showed efficacy in ROS1-positive NSCLC • Up to 1 prior systemic therapy line for NSCLC is allowed • ECOG performance status ≤ 2 (BASEC)
Criteri di esclusione
• Symptomatic brain metastases or symptomatic leptomeningeal involvement • History of malignancies requiring therapy within the last 2 years, except for the NSCLC being studied in this trial, a squamous cell or basal cell carcinoma of the skin, or a completely resected in situ carcinoma • Known tumor-directed co-mutations or rearrangements • Clinically significant cardiovascular disease (either active or within 6 months prior to study entry) (BASEC)
Luogo dello studio
Altro
(BASEC)
Baden
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Bristol Myers Squibb SA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. Dr. Sacha Rothschild
+41 61 2655074
Sacha.rothschild@clutterksb.chKantonsspital Baden AG Onkologie Im Ergel 1
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
07.12.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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