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JOURNAL ONKOLOGIE – STUDIE

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT06116786

Studienbeginn:
November 2023

Letztes Update:
25.04.2024

Wirkstoff:
JNJ-86974680, Cetrelimab

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Johnson & Johnson Enterprise Innovation Inc.

Collaborator:
-

Studienleiter

Johnson & Johnson Enterprise Innovation, Inc Clinical Trial
Study Director
Johnson & Johnson Enterprise Innovation Inc.

Kontakt

Studienlocations
(3 von 9)

Charite Research Organisation GmbH
12203 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Giessen und Marburg GmbH
35392 Giessen
(Hessen)
GermanyRekrutierend» Google-Maps
Roswell Park Comprehensive Cancer Center
14203 Buffalo
United StatesRekrutierend» Google-Maps
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for

further research in combination with cetrelimab and radiation therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Individuals with histologically or cytologically confirmed stage IIIB-IV non-small

cell lung cancer (NSCLC)

- Must have been treated with (a) anti-programmed death protein 1 (anti-PD-1) or

programmed cell death ligand 1 (PD-L1) therapy and (b) platinum-based chemotherapy and

have progressed. Individuals who cannot tolerate or have previously refused

platinum-based chemotherapy are eligible to enroll based on progression after

anti-PD-1/PD-L1 therapy alone

- Can have a prior or concurrent second malignancy (other than the disease under study),

which due to natural history or treatment is unlikely to interfere with any study

endpoints of safety or the efficacy of the study treatment(s)

- Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1

- Adequate liver function:

1. Participants with no underlying hepatic metastases are eligible if they have: i)

aspartate aminotransferase (AST) less than (<)3 x upper limit of normal (ULN),

ii) alanine aminotransferase (ALT) <3 x ULN, and iii) Total bilirubin <1.5 x ULN

2. Participants with known hepatic metastases are eligible if they have: i) AST <5 x

ULN, ii) ALT <5 x ULN, and iii) Total bilirubin <3 x ULN

- Part 1: NSCLC with a known actionable genetic mutation (for example, epidermal growth

factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 [ROS1],

v-raf murine sarcoma viral oncogene homolog B1 [BRAF]) must have received all approved

targeted therapies and have progressed. Participants with unknown mutation status due

to a failed testing status or lack of access to testing are allowed in the study

- Part 2: Participants must have at least 3 lesions on baseline scan, one of which is

evaluable as a target lesion for response assessment per RECIST Version 1.1

- Part 2: Agree to submit tumor samples prior to study treatment which can be an

archival tumor tissue sample obtained within 3 months prior to start of treatment and

without any therapy for NSCLC being administered within these 3 months, or newly

obtained core or incisional biopsy of a tumor lesion during screening

Exclusion Criteria:

- Active disease involvement of the central nervous system with the exception of

definitively locally treated brain metastases that are clinically stable

- Active autoimmune disease that requires systemic immunosuppressive medications (for

example, chronic corticosteroid, methotrexate, or tacrolimus) within the 12 months

prior to signing consent

- Active infection or condition that requires treatment with systemic anti-infective

agents (for example, antibiotics, antifungal or antivirals) within 7 days prior to the

first dose of study treatment or chronic use of anti-infective agents

- History of solid organ or hematologic stem cell transplantation

- Part 2: NSCLC with an actionable genetic mutation for which an approved therapy is

available: EGFR, ALK, ROS1, or BRAF. Confirmation of the absence of actionable

mutations is required

Studien-Rationale

Primary outcome:

1. Number of Participants with Adverse Events (AEs) by Severity (Time Frame - Up to 2 years 5 months):
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

2. Number of Participants with Dose Limiting Toxicities (DLTs) (Time Frame - Up to 2 years 5 months):
The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.

Secondary outcome:

1. Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
Cmax is defined as maximum observed plasma concentration of JNJ-86974680.

2. Minimum Concentration (Cmin) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
Cmin is defined as the minimum observed plasma concentration of JNJ-86974680.

3. Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
Tmax is defined the time to reach the maximum observed plasma concentration of JNJ-86974680.

4. Terminal Elimination Half-life (t1/2) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
T1/2 is defined as terminal elimination half-life of JNJ-86974680.

5. Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
(AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

6. Area Under the Plasma Concentration-time Curve of JNJ-8697468 over the Dosing Interval (tau) (Time Frame - Up to 2 years 5 months):
AUCtau is defined as the area under the plasma concentration-time curve of JNJ-8697468 over the dosing interval (tau).

7. Apparent Clearance (CL/F) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
Apparent clearance of JNJ-86974680 was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

8. Apparent Volume of Distribution (V/F) of JNJ-86974680 (Time Frame - Up to 2 years 5 months):
V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of JNJ-86974680.

9. Part 2: Overall Response Rate (ORR) (Time Frame - Up to 2 years 5 months):
ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks.

10. Part 2: Complete Response Rate (CRR) (Time Frame - Up to 2 years 5 months):
CRR is defined as the proportion of participants with a best response of CR.

11. Part 2: Duration of Response (DOR) (Time Frame - Up to 2 years 5 months):
DoR is defined as the time from the date of first initial documentation of a response to the date of first documented evidence of progression of disease according to immunotherapy response evaluation criteria in solid tumors (iRECIST) or death due to any cause, whichever occurs first.

12. Part 2: Disease Control Rate (DCR) (Time Frame - Up to 2 years 5 months):
DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.

Studien-Arme

  • Experimental: Part 1: JNJ-86974680+Cetrelimab
    Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab.
  • Experimental: Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
    Participants will receive treatment with the identified safe dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.

Geprüfte Regime

  • JNJ-86974680:
    JNJ-86974680 will be administered.
  • Cetrelimab:
    Cetrelimab will be administered.
  • Radiation Therapy:
    Radiation therapy will be administered.

Quelle: ClinicalTrials.gov


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