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EUCTR2015-004105-16

A Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients with Treatment-Naïve Advanced or Recurrent (Stage IIIB Not Amenable For Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy

Datenbasis: WHO (Import vom 26.01.2020)
Geändert: 15.12.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Non-small cell lung cancer
MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]

Interventions (Datenquelle: WHO)


Trade Name: Tecentriq
Product Name: atezolizumab
Product Code: RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Trade Name: Navelbine
Product Name: vinorelbine 10mg/1ml and 50mg/5ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VINORELBINE TARTRATE
Other descriptive name: vinorelbine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Vinorelbine Sandoz
Product Name: vinorelbine 10mg/1ml and 50mg/5ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VINORELBINE TARTRATE
Other descriptive name: vinorelbine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Vinorelbine NC
Product Name: vinorelbine 10mg/1ml and 50mg/5ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VINORELBINE TARTRATE
Other descriptive name: vinorelbine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Navelbine
Product Name: vinorelbine 10mg/1ml and 50mg/5ml
Pharmaceutical Form: Concentrate for solution for infusion

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
- Male or female, age >= 18 years
- Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the American Joint Committee on Cancer (AJCC) 7th edition
- No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected
- No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC NSCLC as per the AJCC 7th edition
- Life expectancy >= 8 weeks
- Deemed unsuitable for any platinum-doublet chemotherapy by the investigator due to poor performance status (ECOG PS of 2-3) However, patients >= 70 years of age who have an ECOG PS of 0 or 1 may be included due to:
a) substantial comorbidities
b) contraindication(s) for platinum doublet chemotherapy.
- Representative formalin-fixed paraffin-embedded (FPPE) tumor tissue block obtained during course of disease (archival tissue) or at screening (tumor blocks are highly preferred for central analysis of PD-L1 expression and exploratory biomarkers)
- Patients with treated, asymptomatic central nervous system (CNS) metastases
- Measurable disease (by RECIST v1.1)
- Adequate hematologic and end organ function
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use protocol defined methods of contraception and to remain abstinent for at least 5 months after the last dose of atezolizumab, and agreement to refrain from donating eggs during this same period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 221
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion criteria:
Cancer-Specific Exclusion Criteria:
- Patients younger than 70 years who have an ECOG PS of 0 or 1
- Active or untreated central nervous system metastases
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX®) are allowed.
- Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L or calcium > 12 mg/dL or corrected serum calcium > ULN)
- History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy

General Medical Exclusion Criteria:
- Women who are pregnant or lactating, or intending to become pregnant during the study. Women of childbearing potential including women who have had a tubal ligation, must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
- History of autoimmune disease
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded)
- History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Known positivity for human immunodeficiency virus (HIV)
- Known active hepatitis B or known active hepatitis C
- Active tuberculosis
- Severe infections within 4 weeks prior to randomization
- Significant cardiovascular disease
- Major surgical procedure other than for diagnosis within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Any serious medical condition (including metabolic dysfunction, physical examination finding) or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study or that may affect the interpretation of the results or render the patient at high risk for treatment complications
- Patients with an illness or condition that may interfere with capacity or compliance with the study protocol, as per investigator's judgment
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to randomization

Exclusion Criteria Related to Atezolizumab:
- History of severe allergic, anaphylactic, or other hypersensitivity rea

Weitere Angaben zur Studie im WHO-Primärregister

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004105-16

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2015-004105-16-SK

Weitere Informationen zur Studie

Registrationsdatum der Studie

18.08.2017

Einschluss der ersten teilnehmenden Person

05.10.2017

Rekrutierungsstatus

Not Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH TREATMENT-NAÏVE ADVANCED OR RECURRENT (STAGE IIIB NOT AMENABLE FOR MULTIMODALITY TREATMENT) OR METASTATIC (STAGE IV) NON-SMALL CELL LUNG CANCER WHO ARE DEEMED UNSUITABLE FOR PLATINUM-CONTAINING THERAPY

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)


Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

Main Objective: - To evaluate the efficacy of atezolizumab compared with single agent chemotherapy in patients with treatment-naïve locally advanced or metastatic NSCLC who are deemed unsuitable for any platinum doublet chemotherapy, as measured by overall survival (OS).;
Secondary Objective: -To evaluate the efficacy of atezolizumab compared with single agent chemotherapy as measured by OS rates at 6, 12, 18 and 24 months
-To evaluate the efficacy of atezolizumab compared with single agent chemotherapy with respect to antitumor effects as measured by investigator assessed ORR using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
-To evaluate the efficacy of atezolizumab compared with single agent chemotherapy with respect to antitumor effects as measured by investigator assessed progression-free survival (PFS) using RECIST v1.1
-To evaluate the efficacy of atezolizumab compared with single agent chemotherapy with respect to antitumor effects as measured by investigator assessed duration of response (DOR) using RECIST v1.1
-To evaluate the safety and tolerability of atezolizumab compared with single agent chemotherapy
-To evaluate and compare PROs of lung cancer symptoms, patient functioning, and health-related quality of life (HRQoL) between treatment arms
;Primary end point(s): 1. Overall Survival;Timepoint(s) of evaluation of this end point: 1. Time from randomization to death from any cause

Sekundäre Endpunkte (Datenquelle: WHO)


Secondary end point(s): 1. Overall Survival rates at 6, 12, 18 and 24 months
2. Objective Response Rate
3. Progression Free Survival
4. Duration of Response
5. Incidence, nature, and severity of adverse events
6. Changes in vital signs, physical findings, and clinical laboratory results
7. Change from baseline in PROs of lung cancer symptoms, patient functioning, HRQoL as assessed by European Organisation for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ-C30) and its supplementary Lung Cancer module (LC13)
8. Time to deterioration (TTD) in patient-reported lung cancer symptoms of cough, dyspnea (single-item and multi-item subscales), chest pain, arm/shoulder pain, or fatigue using EORTC QLQ-C30 and Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13)
;
Timepoint(s) of evaluation of this end point: 1. At Months 6, 12, 18, and 24
2. Time from initial response (partial or complete response) until documented disease progression, or death from any cause, whichever occurs first
3. Time from randomization to the first occurrence of disease progression, or death from any cause, whichever occurs first
4. Time from the first occurrence of a documented objective response to the time of disease progression, or death from any cause, whichever occurs first
5-8. Screening (Days-28 to -1), baseline, Day 1 of all cycles, = 1 Week after Last Dose, =30 days after the last dose of study drug

Kontakt für Auskünfte (Datenquelle: WHO)

F. Hoffmann-La Roche Ltd

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Argentina, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Germany, India, Ireland, Italy, Kazakhstan, Luxembourg, Mexico, Peru, Poland, Portugal, Romania, Slovakia, Spain, Switzerland, United Kingdom, Vietnam

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Trial Information Support Line-TISL
Grenzacherstrasse 124
F. Hoffmann-La Roche Ltd
global.rochegenentechtrials@roche.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Trial Information Support Line-TISL
Grenzacherstrasse 124
F. Hoffmann-La Roche Ltd
global.rochegenentechtrials@roche.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

F. Hoffmann-La Roche Ltd

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

MO29872;2015-004105-16-DE