Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Entrectinib: Unit dose strength(s) is 100 or 200 mg/capsule
Adult patients will receive entrectinib at a dose of 600 mg (3x200mg capsules) orally once daily for 12 months. In pediatric
Sponsors
Roche Products (India) Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Potential patients are eligible to be included in the study only if all of the following criteria apply: 1.Age more than equal to 18 years at the time of signing Informed Consent Form 2. Ability to comply with the study protocol, in the investigatorâ??s judgment 3. Ability to swallow entrectinib intact without chewing, crushing, or opening the capsules 4. Patient has a positive benefit/risk profile for treatment with entrectinib by the investigator. COHORT A (ROS1-POSITIVE NSCLC) SPECIFIC INCLUSION CRITERIA: 1. Histologically- or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C, not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement. 2. Documented positivity for ROS1 gene rearrangements must have been determined locally at CLIA-certified or equivalently accredited diagnostic laboratories using nucleic acid-based testing methods that rely on direct assessment of ROS1 gene rearrangements in tumor tissue. Examples of acceptable methods include NGS, Sanger sequencing, reverse transcriptase-polymerase chain reaction, NanoString and EdgeSeq. Fluorescence in situ hybridization is also an acceptable method, with ROS1 positivity, defined as the detection of at least 15 percent of neoplastic nuclei with ROS1 gene rearrangements among a minimum of 50 total neoplastic nuclei. Immunohistochemistry is not an acceptable method. COHORT B (NTRK FUSION POSITIVE SOLID TUMOR) SPECIFIC INCLUSION CRITERIA: 1. Patients who are 12 years of age or older will be enrolled in this cohort. Patient or legal guardian must provide signed assent and informed consent to participate in the study. 2. Documented NTRK1/2/3 gene fusion positivity, as determined by a Clinical Laboratory Improvement Amendments (CLIA) or equivalently certified next-generation sequencing (NGS) assay (tissue). Gene fusion positivity is defined as a 3â?? NTRK1/2/3 fusion with a protein coding 5â?? gene fusion partner, which are predicted to be in-frame with an intact kinase domain.
Exclusion criteria
Exclusion criteria: Potential patients are excluded from the study if any of the following criteria apply: 1. Patients unable to provide consent 2. Patient is not eligible as per local PI and investigators discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will evaluate the safety and tolerability of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterationsTimepoint: Primary endpoint- Incidence and severity of adverse events AEs with severity determined according to NCI CTCAE v5 grading scale Secondary endpoints- Incidence of SAEs, adverse events of special interest AESIs, greater than equal to Grade 3 AEs, AEs leading to discontinuation of treatment, AEs leading to dose reduction, AEs leading to drug interruption, AEs leading to death | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations.Timepoint: Objective ORR, defined as the proportion of participants with a CR or PR on two consecutive occasions 4 weeks apart, as determined by the investigator according to RECIST v1.1. DOR, defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. Duration of Treatment | — |
Countries
India
Contacts
Public ContactHeta Khokhani
Roche Products India Private Limited
Outcome results
None listed