Phase 2
Completed N=127
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
Non-Small Cell Lung Cancer · ROS1 Proto Oncogene · Crizotinib
Source: ClinicalTrials.gov NCT01945021 ↗
Enrolled (actual)
127
Serious AEs
36.2%
Results posted
Aug 2016
Primary outcomePrimary: Independent Radiology Reviewed Overall Objective Response (ORR) — 88 Participants
Summary
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Independent Radiology Reviewed Overall Objective Response (ORR) |
88 | — |
| SECONDARY IRR-Assessed Duration of Response (DR) |
19.7 | — |
| SECONDARY IRR-Assessed Time to Tumor Response (TTR) |
1.9 | — |
| SECONDARY IRR Assessed Disease Control Rate (DCR) at 8 Weeks |
88.2 | — |
| SECONDARY IRR-Assessed Progression Free Survival (PFS) |
15.9 | — |
| SECONDARY Overall Survival (OS) |
44.2 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs |
127; 46; 124; 11; 68; 41 | — |
| SECONDARY Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 |
0; 0; 0; 2; 1; 5 | — |
| SECONDARY Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Scores |
11.85; 3.08; -0.65; 10.77; 3.20; 5.13 | — |
| SECONDARY Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 Scores |
-4.74; -12.82; -5.12; -1.28; 0.00; 3.85 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
- treatment-naïve or have received no more than 3 systemic treatment regimen(s)
- Positive for translocation or inversion events involving the ROS1 gene
- Negative for translocation or inversion events involving the ALK gene
- Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
- Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
- At least 1 measurable tumor lesion as per RECIST v1.1
- Female or male, 18 years of age or older
- ECOG performance status 0 to 1
- Adequate organ function
- Signed and dated informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
- Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
Exclusion Criteria
- Current treatment on another therapeutic clinical trial
- Prior therapy specifically directed against ALK or ROS1 fusion genes
- Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
- known interstitial fibrosis or interstitial lung disease
- myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
- Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec
- Pregnant or breast feeding
- Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
- Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
- Evidence of active malignancy within last 3 years
Data sourced from ClinicalTrials.gov (NCT01945021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.