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JOURNAL ONKOLOGIE – STUDIE

A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Rekrutierend

NCT-Nummer:
NCT05118789

Studienbeginn:
Januar 2022

Letztes Update:
08.03.2024

Wirkstoff:
NVL-520

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Nuvalent Inc.

Collaborator:
-

Studienleiter

Vivek Upadhyay, MD, MBI
Study Director
Nuvalent Inc.

Kontakt

Studienlocations
(3 von 44)

Cologne University Hospital
Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
UC Davis Comprehensive Cancer Center
95817 Sacramento
United StatesRekrutierend» Google-Maps
University of Colorado Cancer Center
80045 Denver
United StatesRekrutierend» Google-Maps
Georgetown University Medical Center
20007 Washington
United StatesRekrutierend» Google-Maps
University of Miami
33146 Coral Gables
United StatesRekrutierend» Google-Maps
Henry Ford Cancer Institute
48202 Detroit
United StatesRekrutierend» Google-Maps
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Atrium Health Levine Cancer Institute
28204 Charlotte
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
NEXT Oncology - Virginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-Maps
University of Washington / Fred Hutchinson Cancer Center
98109 Seattle
United StatesRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Princess Margaret Cancer Research
M5GG 1L7 Toronto
CanadaRekrutierend» Google-Maps
Hospital Center University De Toulouse
31300 Toulouse
FranceRekrutierend» Google-Maps
National Cancer Center
10408 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Netherlands Cancer Institute
1066 Amsterdam
NetherlandsRekrutierend» Google-Maps
University Medical Centre Groningen
Groningen
NetherlandsRekrutierend» Google-Maps
National University Hospital Singapore
119074 Singapore
SingaporeRekrutierend» Google-Maps
National Cancer Centre Singapore
168583 Singapore
SingaporeRekrutierend» Google-Maps
UOMI Cancer Center - Clinica Tres Torres
08017 Barcelona
SpainRekrutierend» Google-Maps
Vall d'Hebron University Hospital
08035 Barcelona
SpainRekrutierend» Google-Maps
University Hospital of A Coruña
15006 Coruna
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Chung Shan Medical University Hospital
40201 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
704017 Tainan
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts:

- Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy and up

to 1 prior chemotherapy and/or immunotherapy.

- Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy

or immunotherapy.

- Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based

chemotherapy with or without immunotherapy.

- Cohort 2d: ROS1-positive NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior

chemotherapy and/or immunotherapy.

- Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).

2. Disease Criteria:

1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic

solid tumor with documented ROS1 rearrangement.

2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed

locally advanced or metastatic NSCLC with ROS1 rearrangement.

3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or

metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.

3. Prior anticancer treatment (except cohort 2a).

4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1.

Phase 2: Must have measurable disease according to RECIST 1.1.

5. Adequate baseline organ function and bone marrow reserve.

Exclusion Criteria:

1. Patient's cancer has a known oncogenic driver alteration other than ROS1.

2. Known allergy/hypersensitivity to excipients of NVL-520.

3. Major surgery within 4 weeks of first dose of study drug.

4. Ongoing anticancer therapy.

5. Actively receiving systemic treatment or direct medical intervention on another

therapeutic clinical study.

Studien-Rationale

Primary outcome:

1. Maximum Tolerated Dose (MTD) (Phase 1) (Time Frame - Within 28 days of last patient dosed during dose escalation):
Highest dose with dose-limiting toxicity (DLT) rate ≤ 25%

2. Recommended Phase 2 Dose (RP2D) (Time Frame - Within 28 days of last patient dosed during dose escalation.):
To determine the RP2D

3. Objective Response Rate (ORR) (Phase 2) (Time Frame - 2-3 years after first patient dosed.):
To determine ORR as assessed by BICR

Secondary outcome:

1. Number of participants with treatment-emergent adverse events, as assessed by CTCAE, v5.0 (Time Frame - Approximately 3 years.):
Incidence and severity of treatment-emergent adverse events (TEAEs)

2. Maximum plasma concentration (Cmax) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the maximum plasma concentration (Cmax) of NVL-520

3. Plasma concentration at the end of the dosing interval (Ctau) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the plasma concentration at the end of the dosing interval (Ctau) of NVL-520

4. Average plasma concentration (Cavg) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the average plasma concentration (Cavg) of NVL-520

5. Time of maximum concentration (Tmax) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the time of maximum concentration (Tmax) of NVL-520

6. Area under the curve at the end of the dosing interval (AUCtau) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the area under the curve at the end of the dosing interval (AUCtau) of NVL-520

7. Area under the curve from time 0 to 24 (AUC0-24) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the area under the curve from time 0 to 24 (AUC0-24) of NVL-520

8. Area under the curve from time 0 to infinity (AUCinf) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the area under the curve from time 0 to infinity (AUCinf) of NVL-520

9. Oral clearance (CL/F) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the oral clearance (CL/F) of NVL-520

10. Volume of distribution (Vz/F) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the volume of distribution (Vz/F) of NVL-520

11. Half-life (t1/2) of NVL-520 (Time Frame - Pre-dose and up to 24 hours post-dose):
To determine the half-life (t1/2) of NVL-520

12. Objective response rate (ORR) (Time Frame - 2-3 years after first patient dosed):
Determine ORR as assessed by BICR

13. Duration of response (DOR) (Time Frame - 2-3 years after first patient dosed):
Determine DOR of NVL-520 until radiographic disease progression or death

14. Clinical benefit rate (CBR) (Time Frame - 2-3 years after first patient dosed):
Determine CBR of NVL-520

15. Time to response (Time Frame - 2-3 years after first patient dosed):
Determine time to response of NVL-520

16. Progression-free survival (PFS) (Time Frame - Approximately 3 years):
Determine PFS of NVL-520 until radiographic disease progression or death

17. Overall survival (OS) (Time Frame - Approximately 3 years):
Determine OS

18. Rate of CNS progression (Time Frame - Approximately 3 years):
The incidence of CNS as first site of progression, alone or with concurrent extra-CNS progression

19. Intracranial objective response rate (IC-ORR) (Time Frame - Approximately 3 years):
Determine the intracranial objective response rate

20. Quality of life assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (Time Frame - 2-3 years after first patient dosed):
EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.

21. Quality of life assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29) (Time Frame - 2-3 years after first patient dosed):
EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." For symptoms scales, higher scores indicated greater symptom burden.

Studien-Arme

  • Experimental: Phase 1 dose escalation
    NVL-520 oral daily dosing
  • Experimental: Cohort 2a
    ROS1+ NSCLC naïve to TKI therapy and up to 1 prior chemotherapy and/or immunotherapy
  • Experimental: Cohort 2b
    ROS1+ NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy
  • Experimental: Cohort 2c
    ROS1+ NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy
  • Experimental: Cohort 2d
    ROS1+ NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy
  • Experimental: Cohort 2e
    ROS1+ solid tumor and progressed on any prior therapy

Geprüfte Regime

  • NVL-520:
    Oral tablet of NVL-520

Quelle: ClinicalTrials.gov


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