MASTER SCREENING STUDY TO DETERMINE BIOMARKER STATUS AND POTENTIAL TRIAL ELIGIBILITY FOR PATIENTS WITH MALIGNANT TUMORS
- Conditions
- biomarker in NSCLC non small cell lung cancer10038666
- Registration Number
- NL-OMON56117
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
General Inclusion Criteria
Patients must meet the following criteria for study entry:
- Signed Informed Consent Form
- Age 18 years or above at time of signing Informed Consent Form
- Given that the aim of Study BX43361 is to assign patients to a
biomarker-appropriate linked Roche clinical trial:
- Awareness of and willingness, in principle, to participate in an assigned
cohort of a linked Roche clinical trial
- Ability to comply with future investigational treatment protocol procedures
in the investigator*s judgment and based on discussion with the patient, for
example, dosing of medication (e.g., oral or IV), tumor assessments, safety
monitoring, agreement to meet contraceptive requirements, and completion of
questionnaires
- Confirmed availability of a representative formalin-fixed, paraffin-embedded
(FFPE) tumor specimen.
- Adequate hematologic and end-organ function by the investigator*s clinical
judgement, including the following:
- No clinically significant hematologic (CBC), coagulation, or biochemistry
test results
- No indications and/or known history of clinically significant acute or
chronic liver, or kidney injury
Stage-Specific Inclusion Criteria
Patients with Stage III NSCLC
Patients with Stage III NSCLC must meet the following criteria for study entry:
- Locally advanced, unresectable Stage III NSCLC of either squamous or
non-squamous histology based on 8th edition of the American Joint Committee on
Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging
system with plans to receive, currently receiving, or received chemoradiation
treatment
- Representative FFPE tumor specimen obtained prior to the start of any
chemoradiotherapy
- Eastern Cooperative Oncology Group (ECOG) Group Performance Status of 0, 1, or
2
Patients with Stage II, IIIA or Select IIIB (T3N2 only) NSCLC Requiring
Adjuvant Treatment
Patients with Stage I to IIIA NSCLC must meet the following criteria for study
entry:
- Stage I to IIIA NSCLC based on the 8th edition of the AJCC and UICC cancer
staging system
- Considered eligible for curative intent surgery (complete resection with all
surgical margins testing negative for tumor).
- Screening within Study BX43361, using a pretreatment biopsy, is encouraged to
be performed as early in the patient treatment pathway as possible to ensure
the patient is potentially eligible for all cohorts
• Representative FFPE tumor specimen obtained prior to the start of
o For patients enrolled following surgery:
These patients should achieve complete resection of histologically confirmed
Stage I to Stage IIIA with all surgical margins testing negative for tumor.
o It is strongly recommended that patients should be enrolled no more than 8
weeks after surgery, and prior to post-operative chemotherapy (as applicable).
Investigators should make reference to the relevant linked Roche clinical trial
protocol to ensure sufficient time is given to subsequently screen the patient
within the linked trial for biomarker-eligible patients identified.
- For patients enrolled prior to surgery:
There must be sufficient tumor biopsy tissue available for evaluation prior to
the start of any anti-cancer treatment (if receiving neoadjuvant therapy).
- Representative FFPE tumor specimen obtained prior to the star
General Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study
entry:
- Pregnant or breastfeeding, or intending to become pregnant during the study
Women of childbearing potential who are required (and have consented) to have a
study-mandated procedure for which pregnancy would impact the risks to the
patient and/or fetus per local guidelines must have a negative serum pregnancy
test result within 7 days prior to the procedure.
- History of malignancy other than NSCLC within 5 years prior to screening,
except for malignancies with a negligible risk of metastasis or death
- 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 patient
at high risk from treatment complications. This includes any of the following:
o Known clinically significant liver disease (e.g., active viral, alcoholic, or
other hepatitis; cirrhosis; current alcohol abuse)
o Significant cardiovascular disease (e.g., New York Heart Association Class II
or greater cardiac disease, myocardial infarction, or cerebrovascular accident)
within 3 months prior to enrollment, unstable arrhythmia, or unstable angina
- Recent major surgical procedure or anticipation of a need for a major
surgical procedure, except for patients who have recently had and have adequate
healing after complete surgical resection of tumor
- Prior allogeneic stem-cell or solid-organ transplantation
- Recent or ongoing severe or clinically significant infection, including but
not limited to, hospitalization for complications of infection, bacteremia, or
severe pneumonia
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Proportion of patients with evaluable biomarker results<br /><br>- Proportion of patients who are identified as being biomarker eligible for a<br /><br>linked Roche clinical trial</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Prevalence of selected biomarkers in the screened population according to<br /><br>disease indication<br /><br>- Prevalence of selected biomarkers in the screened population summarized by<br /><br>demographic or clinical features, including but not limited to, disease<br /><br>indication or stage, geographic location, and prior cancer therapy<br /><br>- Characterization of next treatment according to disease indication and<br /><br>biomarker profile</p><br>