Phase 3 study comparing MRTX849 and Docetaxel in patients with pretreated lung cancer with KRAS-G12C mutation
Descrizione riassuntiva dello studio
This is an open-label, randomized study of an (experimental) investigational drug called MRTX849, which is administered alone (as the only active ingredient) compared to chemotherapy with Docetaxel (also known as TAXOTERE®), which is administered as the only active ingredient. The primary objective of this study is to compare the efficacy of MRTX849 with Docetaxel in patients with advanced non-small cell lung cancer (NSCLC) with a specific alteration of tumor genes (KRAS-G12C mutation), in whom there has been disease progression previously during or after chemotherapy and immunotherapy. It is expected that up to 450 patients will participate in this study.
(BASEC)
Intervento studiato
Arm:
Experimental: MRTX849
Active comparator: Docetaxel
Intervention / Treatment:
Drug: MRTX849
21-day cycles
Drug: Docetaxel
21-day cycles
Other name: Taxotere
Treatment:
Patients who meet the eligibility criteria and choose to participate in the study will be randomly assigned (like flipping a coin) to one of the two treatment groups.
Treatment group 1: MRTX849 (investigational drug, experimental treatment)
Treatment group 2: Docetaxel (comparator drug, standard treatment)
(BASEC)
Malattie studiate
Advanced non-small cell lung cancer (NSCLC) with a specific alteration of tumor genes (a KRAS-G12C mutation)
(BASEC)
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC with KRAS-G12C mutation - Intended for treatment with Docetaxel Additional inclusion criteria apply, which will be verified by the physician (BASEC)
Criteri di esclusione
- Prior treatment with a drug targeting the KRAS-G12C tumor mutation (e.g., AMG 510) - Active brain metastases Additional exclusion criteria apply, which will be verified by the physician (BASEC)
Luogo dello studio
Basilea, Winterthur
(BASEC)
Sponsor
PRA Switzerland AG, Lange Gasse 15, 4002 Basel, Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Laetitia Mauti
+41 52 266 23 73
laetitia.mauti@clutterksw.chKantonsspital Winterthur, Medizinische Onkologie und Hämatologie, Brauerstr. 15, 8401 Winterthur, Switzerland
(BASEC)
Informazioni generali
Bristol-Myers Squibb
(ICTRP)
Informazioni scientifiche
Bristol-Myers Squibb
(ICTRP)
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
27.09.2021
(BASEC)
ID di studio ICTRP
NCT04685135 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated4 Non-Small Cell Lung Cancer with KRAS G12C Mutation (BASEC)
Titolo accademico
A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation (ICTRP)
Titolo pubblico
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (ICTRP)
Malattie studiate
Metastatic Non Small Cell Lung Cancer;Advanced Non Small Cell Lung Cancer (ICTRP)
Intervento studiato
Drug: MRTX849;Drug: Docetaxel (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C
mutation.
- Candidacy to receive treatment with docetaxel.
Crossover Inclusion Criteria:
- Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
- ECOG performance status 0-2
Exclusion Criteria:
- Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
- Active brain metastases.
Crossover Exclusion Criteria:
- Receipt of any other systemic anti-cancer therapy after last administration of
docetaxel on the study. (ICTRP)
non disponibile
Endpoint primari e secondari
Progression-Free Survival (PFS) as Per Blinded Independent Central Review (ICTRP)
Overall Survival (OS);Objective Response Rate (ORR) as Per Blinded Independent Central Review;Duration of Response (DOR) as Per Blinded Independent Central Review;1-Year Survival Rate;Number of Participants With Treatment Emergent Adverse Events (TEAEs);Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters;Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters;Plasma Concentration of Adagrasib;Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score;Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score;Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score;Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score;Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score (ICTRP)
Data di registrazione
21.12.2020 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
ID secondari
CA239-0013, 849-012, CA239-0013 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04685135 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile