JOURNAL ONKOLOGIE – STUDIE

A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04267237

Studienbeginn:
März 2021

Letztes Update:
05.01.2021

Wirkstoff:
Atezolizumab, RO7198457

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: GO41836 www.roche.com/about_roche/roche_worldwide.html
Kontakt:
Phone: 888-662-6728 (US Only)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations (3 von 25)

Zentralklinik Bad Berka GmbH; Pneumologie
99437 Bad Berka
(Thüringen)
GermanyRekrutierend» Google-Maps

Interdisziplinäres Brustzentrum am Klinikum Esslingen
Hirschlandstraße 97
73730 Esslingen am Neckar
(Baden-Württemberg)
DeutschlandRekrutierend» Google-Maps

City of Hope
91010 Duarte
United StatesRekrutierend» Google-Maps

UCSF Helen Diller Family CCC
94158 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps

Florida Cancer Specialists - Fort Myers (Broadway)
33901 Fort Myers
United StatesRekrutierend» Google-Maps

Florida Cancer Specialists
33401 West Palm Beach
United StatesRekrutierend» Google-Maps

University Cancer & Blood Center, LLC; Research
30607 Athens
United StatesRekrutierend» Google-Maps

Winship Cancer Institute
30322 Atlanta
United StatesRekrutierend» Google-Maps

St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood
41017 Edgewood
United StatesRekrutierend» Google-Maps

Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps

Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps

Comprehensive Cancer Centers of Nevada
89128 Las Vegas
United StatesRekrutierend» Google-Maps

Oregon Health and Science University Cancer Institute
97239 Portland
United StatesRekrutierend» Google-Maps

Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps

Peter MacCallum Cancer Centre-East Melbourne
3000 Melbourne
AustraliaRekrutierend» Google-Maps

Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaRekrutierend» Google-Maps

Princess Margaret Cancer Center
M5G 1Z5 Toronto
CanadaRekrutierend» Google-Maps

Hospital Teresa Herrera (CHUAC) ; Sala de Sesiones de Oncología
15006 A Coruña
SpainRekrutierend» Google-Maps

Clinica Universitaria de Navarra; Servicio de Oncologia
31008 Pamplona
SpainRekrutierend» Google-Maps

Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps

Clinica Universidad de Navarra Madrid; Servicio de Oncología
28027 Madrid
SpainRekrutierend» Google-Maps

Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia
29010 Malaga
SpainRekrutierend» Google-Maps

Hospital Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps

Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps

Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
50009 Zaragoza
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

This study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and

biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with

Stage II-III non-small cell lung cancer (NSCLC) who are circulating tumor DNA (ctDNA)

positive following surgical resection and have received standard-of-care adjuvant

platinum-doublet chemotherapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age >= 18 years;

- Resected Stage II-III Non-small Cell Lung Cancer (NSCLC) per American Joint Committee

on Cancer staging criteria, 8th revised edition;

- Complete R0 resection of Stage II or III NSCLC prior to enrollment and adequate

recovery from surgery;

- Pathological evaluation of mediastinal lymph nodes preoperatively or intraoperatively;

- ctDNA (circulating tumor DNA) identified in plasma after resection of Stage II-III

NSCLC and prior to start of adjuvant platinum-doublet therapy, as determined by

central testing;

- Treatment with at least two cycles of adjuvant platinum-doublet chemotherapy regimens

for resected NSCLC;

- No unequivocal evidence of disease after surgery and adjuvant platinum-doublet

chemotherapy, as assessed on imaging (computed tomography [CT] scan or magnetic

resonance imaging [MRI]) within 28 days prior to randomization;

- Availability of adequate tumor material;

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;

- Adequate hematologic and end-organ function;

- Negative HIV test at screening;

- Negative hepatitis B test at screening;

- Negative hepatitis C test at screening.

Exclusion Criteria:

- Participants with a known mutation in exons 18-21 of epidermal growth factor receptor

(EGFR) or with a known anaplastic lymphoma kinase (ALK) or reactive oxygen species

(ROS) alteration;

- History of malignancy other than disease under study within 5 years prior to

enrollment, with the exception of malignancies with a negligible risk of metastasis or

death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin

cancer, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine

cancer;

- Induction and neoadjuvant systemic therapy prior to resection of NSCLC;

- Radiotherapy prior to or after resection of NSCLC;

- Prior systemic investigational therapy;

- Prior anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or a cancer

vaccine;

- Treatment with systemic immunostimulatory agents within 6 weeks or 5 drug elimination

half-lives, prior to initiation of study treatment;

- Treatment with systemic immunosuppressive medication within 2 weeks prior to

initiation of study treatment or anticipation of need for systemic immunosuppressive

medication during study treatment;

- Treatment with monoamine oxidase inhibitors (MAOIs) within 3 weeks prior to initiation

of study treatment or requirement for ongoing treatment with MAOIs;

- Active or history of autoimmune disease or immune deficiency;

- Known primary immunodeficiencies, either cellular or combined T-cell and B-cell

immunodeficiencies;

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced

pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening

chest CT scan;

- Significant cardiovascular disease;

- Major surgical procedure, other than for diagnosis or for resection of disease under

current study, within 4 weeks prior to initiation of study treatment, or anticipation

of need for a major surgical procedure during the study;

- Known active or latent tuberculosis infection;

- Recent acute infection;

- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study

treatment, or anticipation of need for such a vaccine during study treatment or within

5 months after the final dose of study treatment;

- Prior allogeneic stem cell or solid organ transplantation;

- Any other disease, metabolic dysfunction, physical examination finding, or clinical

laboratory finding that contraindicates the use of an investigational drug, may affect

the interpretation of the results, or may render the participants at high risk from

treatment complications;

- Known clinically significant liver disease;

- Previous splenectomy;

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies

or fusion proteins;

- Known hypersensitivity to Chinese hamster ovary cell products or any component of the

atezolizumab formulation;

- Known allergy or hypersensitivity to any component of RO7198457;

- Pregnant or lactating women.

Studien-Rationale

Primary outcome:

1. Disease-free Survival (DFS) (Time Frame - Up to 62 months):
DFS as assessed by the investigator, is defined as the time from randomization to the date of first documented recurrence of NSCLC or occurrence of new primary NSCLC or death due to any cause, whichever occurs first.

Secondary outcome:

1. Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) (Time Frame - Up to 90 days after the final dose of study drug or until initiation of another systemic anti-cancer therapy (up to approximately 62 months))

2. Plasma Concentrations of RNA at Specified Timepoints (Time Frame - Arm B: Days 1, 8, 15, 22 of Cycle 1 (each cycle is 28 days), Day 1 of Cycle 2, 3, 5, 7, 9, 11 and treatment discontinuation (TD) visit (up to 12 months))

3. Plasma Concentrations of (R)-N,N,N-trimethyl-2,3-dioleyloxy-1-propanaminium chloride (DOTMA) at Specified Timepoints (Time Frame - Arm B: Days 1, 8, 15, 22 of Cycle 1 (each cycle is 28 days), Day 1 of Cycle 2, 3, 5, 7, 9, 11 and treatment discontinuation (TD) visit (up to 12 months))

4. Maximum Serum Concentration (Cmax) of Atezolizumab at Specified Timepoints (Time Frame - Arm A and Arm B: Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months))

5. Minimum Serum Concentration (Cmin) of Atezolizumab at Specified Timepoints (Time Frame - Arm A and Arm B: Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months))

6. Change from Baseline in Number of Participants With Anti-drug Antibodies (ADA) to Atezolizumab (Time Frame - Arm A and Arm B: Baseline, Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months))

Studien-Arme

Experimental: Atezolizumab
Participants will receive atezolizumab on Day 1 of each 28-day cycle (Q4W) for 12 cycles.
Experimental: Atezolizumab + RO7198457
Participants will receive atezolizumab Q4W along with RO7198457 for 12 cycles.

Geprüfte Regime

Atezolizumab (Tecentriq):
Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
RO7198457:
RO7198457 will be administered by IV infusion at protocol-defined intervals for 12 cycles.

Quelle: ClinicalTrials.gov