Clinical trial/study for lung cancer patients with ROS1 positive
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2022/04/041861
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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. No prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy, or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
3. Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization. Patients who received brain irradiation must have completed whole brain radiotherapy at least 14 days prior and/or stereotactic radiosurgery at least 7 days prior to the start of entrectinib treatment.
4. Measurable systemic disease according to RECIST v1.1
5. Life expectancy of at least 12 weeks
6. ECOG Performance Status of 0, 1, or 2
7. Adequate hematologic, renal, liver functions
8. Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
9. Ability to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the
capsules
10. Ability to comply with the study protocol, in the investigator’s judgment
11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 5 weeks after the last dose of entrectinib or for at least 90 days after the last dose of crizotinib
12. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
1. Current participation in another therapeutic clinical trial
2. Prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
3. NCI-CTCAE v5.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia, fatigue, nausea and lack of appetite), which have not shown improvement and are strictly considered to interfere with current study drug
4. History of recent (within the past 3 months) symptomatic congestive heart failure or ejection
fraction ? 50% observed during screening for the study
5. History of prolonged corrected QT interval
6. History of additional risk factors for torsades de pointes
7. Grade = 2 peripheral sensory neuropathy
8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
9. Previous malignancy within the past 3 years
10. Incomplete recovery from any surgery prior to the start of study treatment that would
interfere with the determination of safety or efficacy
11. Active GI disease (e.g., Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndrome that would reasonably impact drug absorption
12. History of prior therapy-induced pneumonitis
13. Any condition (in the past 3 months) e.g., myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, stroke, symptomatic bradycardia, or uncontrolled arrhythmias requiring medication
14. Known active infections that would interfere with the assessment of safety or efficacy of
study treatments (bacterial, fungal or viral), with the exceptions of HIV, hepatitis B virus
(HBV), and hepatitis C virus (HCV) infections
15. History of hypersensitivity to any of the additives in the entrectinib and/or crizotinib drug formulations
16. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of entrectinib or crizotinib
17. Any clinically significant concomitant disease or condition that could interfere with, or for
which the treatment might interfere with, the conduct of the study or the absorption of oral
medications or that would, in the opinion of the Principal Investigator, pose an unacceptable
risk to the patient in this study
18. Any psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS (Progression-free survival) defined by RECIST v1.1 <br/ ><br>Timepoint: Screening <br/ ><br>Visit 1 <br/ ><br>Visit 2 <br/ ><br>All subsequent visit after 8 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method CNS-PFS defined by RECIST v1.1Timepoint: Screening <br/ ><br>Visit 1 <br/ ><br>Visit 2 <br/ ><br>All subsequent visit after 8 weeks <br/ ><br>