A PHASE II/III MULTICENTER STUDY EVALUATING THEEFFICACY AND SAFETY OF MULTIPLE TARGETEDTHERAPIES AS TREATMENTS FOR PATIENTS WITHADVANCED OR METASTATIC NONSMALL CELL LUNGCANCER (NSCLC) HARBORING ACTIONABLE SOMATICMUTATIONS DETECTED IN BLOOD (BFAST: BLOOD FIRSTASSAY SCREENING TRIAL)
- Conditions
- -C349 Bronchus or lung, unspecifiedBronchus or lung, unspecifiedC349
- Registration Number
- PER-030-18
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
Signed informed consent form for the blood-based screening part of the study and
willingness to participate in an assigned cohort based on their identified oncogenic somatic
mutation(s)
Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to
treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic)
NSCLC
Mixed tumors should be categorized according to the predominant cell type.
No prior systemic treatment for unresectable Stage IIIb or IV NSCLC
Age 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 02
Measurable disease (as defined by RECIST, v1.1)
Adequate recovery from most recent systemic or local treatment for cancer
Adequate organ function, as demonstrated by the following clinical laboratory parameters:
Hemoglobin 9 g/dL
ANC 1.0 109/L
Platelet count 75 109/L
Serum AST and ALT 2.5 the upper limit of normal (ULN) or 5 ULN for patients
with concurrent liver metastases
Bilirubin 2 ULN or 5 ULN for patients with concurrent liver metastases
Serum creatinine 2 ULN or creatinine clearance 45 mL/min
Life expectancy 12 weeks
For female patients of childbearing potential and male patients, willingness to use
acceptable methods of contraception
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, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior
to randomization, unstable arrhythmias, or unstable angina
Patients with known coronary artery disease, congestive heart failure not meeting the
above criteria, or known left ventricular ejection fraction 50% must be on a stable
medical regimen that is optimized in the opinion of the treating physician, in
consultation with a cardiologist if appropriate.
Known HIV positivity or AIDS-related illness
Either a concurrent condition (including medical illness, such as active infection requiring
treatment with intravenous antibiotics or the presence of laboratory abnormalities) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Criteria of version 1.1 of the RECIST<br>Measure:COHORT C<br>Investigator-assessed PFS (progression-free survival) according to RECIST v1.1<br>Timepoints:Throughout the study<br>;<br>Outcome name:Criteria of version 1.1 of the RECIST<br>Measure:COHORT D<br>Investigator-assessed ORR (objective response rate) based on confirmed objective response<br>Timepoints:Throughout the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Criteria of version 1.1 of the RECIST<br>Measure:COHORT C<br>PFS (progression-free survival), ORR (objective response rate), and DOR (duration of response) according to RECIST v1.1<br>Timepoints:Throughout the study<br>;<br>Outcome name:Criteria of version 1.1 of the RECIST<br>Measure:COHORT D<br>Investigator-assessed DOR (duration of response), CBR (clinical benefit rate), and PFS (progression-free survival) per RECIST v1.1<br>Timepoints:Throughout the study<br>