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EUCTR2017-000076-28

A Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: blood-first assay screening trial)

Datenbasis: WHO (Import vom 29.03.2024)
Geändert: 19.05.2022, 14:12
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Advanced or metastatic Non-small cell lung cancer (NSCLC)
MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]

Interventions (Datenquelle: WHO)


Product Name: Alectinib
Product Code: RO5424802
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ALECTINIB
Current Sponsor code: Ro542-4802/F03, Ro542-4802/F16
Other descriptive name: ALK INHIBITOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Atezolizumab (MPDL3280A)
Product Code: RO5541267
Pharmaceutical Form: Concentrate for 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: ALIMTA 500 mg powder for concentrate for solution for infusion
Product Name: Pemetrexed
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PEMETREXED
CAS Number: 137281-23-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Gemcitabine Actavis 38 mg/ml powder for solution for infusion
Product Name: Gemcitabine
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Cisplatin NeoCorp 1 mg/ml
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
Other descriptive name: CISPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Trade Name: Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion
Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Carboplatin
Other descriptive name: CARBOPLATIN
Concentration unit: mg/ml milligram(

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Measurable disease (as defined by RECIST, v1.1)
- Adequate recovery from most recent systemic or local treatment for cancer
- Adequate organ function
- Life expectancy >=12 weeks
- For female patients of childbearing potential and male patients, willingness to use acceptable methods of contraception


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 389
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 392

Exclusion criteria:
- Inability to swallow oral medication
- Women who are pregnant or lactating
- Symptomatic, untreated CNS metastases
Patients with treated and/or asymptomatic brain metastases may still be eligible for treatment on the study depending on individual cohort requirements; see the cohort specific appendices for details regarding eligibility
- History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5 year OS rate = 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ of breast, or Stage I uterine cancer
- Significant cardiovascular disease
- Known HIV positivity or AIDS-related illness
- Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
- Inability to comply with other requirements of the protocol


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

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2017-000076-28
Weitere Informationen zur Studie

Datum der Studienregistrierung

10.08.2017

Einschluss der ersten teilnehmenden Person

24.11.2017

Rekrutierungsstatus

Authorised-recruitment may be ongoing or finished

Wissenschaftlicher Titel (Datenquelle: WHO)

A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (B-FAST: BLOOD-FIRST ASSAY SCREENING TRIAL)

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)

Controlled: no
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: no
Placebo: no
Other: no
Number of treatment arms in the trial: 5

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

Main Objective: • To evaluate the efficacy of multiple therapies in patients with NSCLC selected according to results from the FoundationOne Liquid Companion Diagnostic (F1LCDx): alectinib (ALK+; RET+); entrectinib (ROS1+); atezolizumab (atezo) + cobimetinib (cobi) + vemurafenib (vem) (BRAF V600+); atezo + bevacizumab (bev) + carboplatin + pemetrexed (EGFR exon 20+)

• To evaluate the efficacy of atezo compared with platinum-based chemotherapy in treatment-naive patients with inoperable Stage IIIB or Stage IV NSCLC in patients who are blood tumor mutational burden positive according to F1LCDx (Cohort C)

;Secondary Objective: To evaluate:
• The safety and tolerability of alectinib, atezo, entrectinib, atezo + cobi + vem, atezo + bev + carboplatin + pemetrexed (Cohorts A, B, C, D E, F)
• The pharmacokinetic (PK) characteristics of alectinib in RET+ patients (Cohort B), entrectinib in ROS1+ patients (Cohort D), atezo in BRAF V600+ patients (Cohort E) and in patients with EGFR exon 20+ advanced or metastatic NSCLC (Cohort F)
• The impact of study treatment on patient-reported outcome (PROs)
• The efficacy of entrectinib in patients with ROS1+ advanced or metastatic NSCLC, atezo +cobi + vem in patients with BRAF V600+, and atezo + bev + carboplatin + pemetrexed in patients with EGFR exon 20+ advanced or metastatic NSCLC, as determined by the F1LCDx assay
• Prognostic effect and pharmacodynamics of exploratory biomarkers in blood, and their association with disease status, mechanisms of resistance, and/or response to alectinib (Cohorts A, B), atezo (Cohort C, E, and F), entrectinib (Cohort D)
;Primary end point(s): 1. Investigator-assessed ORR based on confirmed objective response (Cohorts A, B, D, and F)
2. Investigator-assessed PFS according to RECIST v1.1 (Cohort C) in bTMB the primary population of patients with a bTMB level equal to or greater than the higher validated cutoff (PP1)
3. Investigator-assessed 12-month time in response (TIR) per RECIST v1.1 (Cohort E)



;Timepoint(s) of evaluation of this end point: 1-3. Up to 6 years

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): 1. Investigator-assessed DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)
2. IRF-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)
3. IRF-assessed PFS, ORR, and DOR according to RECIST v1.1 (Cohort C and F)
4. Investigator-assessed ORR, and DOR according to RECIST v1.1 (Cohort C)
5. Investigator- and IRF-assessed time to CNS progression according to RECIST v1.1 (Cohort D)
6. Investigator-assessed intracranial tumor response rate by RECIST 1.1 in patients with measurable CNS disease at baseline (Cohort D)
7. OS (Cohorts A, B, D, E, and F)
8. Investigator-assessed PFS rates at 6-month and 1-year landmark timepoints (Cohort C)
9. Incidence, type, and severity of adverse events (based on the NCI CTCAE v4.0), including SAEs and AEs of special interest (Cohorts A, B, C, D, E, and F)
10. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified IMPs (Cohorts A, B, D, E, and F)
11. DLTs, if any, associated with alectinib at escalating doses in RET+ patients (Cohort B)
12. PK parameters of alectinib in RET+ patients (Cohort B)
13. Population PK analysis for entrectinib (Cohort D)
14. Proportion of patients who improved compared with baseline in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain and TTD as measured by SILC (Cohorts A, B, C, D, E, and F)
15. Proportion of patients presenting with measurable CNS disease at baseline who improve compared with baseline in patient-reported cognitive function, fatigue, health-related quality of life (HRQoL), headache, and vision disorder per the corresponding scales of the EORTC QLQ-C30 and BN20 (Cohort D)
16. Mean change from baseline in HRQoL, patient functioning, and symptoms as measured by the EORTC
QLQ-C30 (Cohorts A, B, C, D, E, and F)
17. Health status as assessed by the EQ-5D-5L questionnaire (Cohorts A, B, C, D, E, and F)
18. Relationship between circulating biomarkers related to alectinib exposure and efficacy (Cohorts A and B), to atezolizumab efficacy (Cohort C) to entrectinib efficacy (Cohort D), atezo + cobi + vem efficacy (Cohort E), and atezo + bev + carboplatin + pemetrexed efficacy (Cohort F)
19. OS in bTMB PP1 (Cohort C)
20. Investigator-assessed PFS according to RECIST v1.1 in bTMB the secondary population of all patients who are bTMB-positive, which is the intent-to-treat (ITT) population in this cohort (PP2) [Cohort C]
21. OS in bTMB PP2 (Cohort C)
22. Investigator and IRF-assessed -assessed ORR, DOR, and PFS per RECIST v1.1 (Cohort E)
23. Investigator-assessed DOR and PFS per RECIST v1.1 (Cohort F)
24. 9-month TIR (Cohort E)
25. 12-month TIR (Cohort E)
26. Serum concentration of atezo at specified timepoints (Cohort E and F)
27. Presence of ADAs against atezo during the study relative to the presence of ADAs at baseline (Cohort E and F);Timepoint(s) of evaluation of this end point: 1-7. Up to 6 years
8. At 6 month and 1 year
9-10. Up to 6 years
11. From Day 1 (D1) to D28 of Cycle 1 (C1)
12. Dose-Finding Phase: C1D1, C1D8, C2D1, C3D1, C4D1
Expansion Phase: C1D1, C2D1, C3D1, C4D1
13. C1D1, C3D1, C5D1
14- 17. At 3 and 6 months following disease progression up to 6 years
18-23. Up to 6 years
24. 9 months
25. 12 months
26-27. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1 and at treatment discontinuation visit

Kontakt für Auskünfte (Datenquelle: WHO)

F. Hoffmann-La Roche Ltd

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (B-FAST: BLOOD-FIRST ASSAY SCREENING TRIAL)

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Möglicherweise erscheint hier die Schweiz noch nicht als Durchführungsland, weil sie im WHO-Primärregister noch nicht eingetragen wurde.
Argentina, Australia, Belgium, Brazil, Canada, Chile, Costa Rica, France, Germany, Hong Kong, Israel, Italy, Korea, Mexico, New Zealand, Peru, Poland, Republic of, Russian Federation, Serbia, Singapore, Spain, Taiwan, Thailand, Turkey, United States

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

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

BO29554
2017-000076-28-ES
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