Phase 3 study comparing MRTX849 and Docetaxel in patients with pretreated lung cancer with KRAS-G12C mutation
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Basel, Winterthur
(BASEC)
Sponsor
PRA Switzerland AG, Lange Gasse 15, 4002 Basel, Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Laetitia Mauti
+41 52 266 23 73
laetitia.mauti@clutterksw.chKantonsspital Winterthur, Medizinische Onkologie und Hämatologie, Brauerstr. 15, 8401 Winterthur, Switzerland
(BASEC)
Allgemeine Auskünfte
Bristol-Myers Squibb
(ICTRP)
Wissenschaftliche Auskünfte
Bristol-Myers Squibb
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
27.09.2021
(BASEC)
ICTRP Studien-ID
NCT04685135 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated4 Non-Small Cell Lung Cancer with KRAS G12C Mutation (BASEC)
Wissenschaftlicher Titel
A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation (ICTRP)
Öffentlicher Titel
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (ICTRP)
Untersuchte Krankheit(en)
Metastatic Non Small Cell Lung Cancer;Advanced Non Small Cell Lung Cancer (ICTRP)
Untersuchte Intervention
Drug: MRTX849;Drug: Docetaxel (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
21.12.2020 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
Sekundäre IDs
CA239-0013, 849-012, CA239-0013 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04685135 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar