ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON-SMALL CELL LUNG CANCER
Conditions
Interventions
AQUA07:Oral
Lorlatinib:Oral
Sponsors
Agajanov, Tamara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >= 18 years (or >= 20 years if required by local regulation) at time of signing Informed Consent Form Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.) Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC Measurable disease per RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Ability and willingness to take oral medication(s) Adequate organ function and bone marrow reserve
Exclusion criteria
Exclusion criteria: Prior toxicities from anti-cancer therapy which have not resolved to Grade <= 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy. Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease Significant cardiovascular disease Inadequately controlled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety To evaluate the safety and tolerability based on NCI CTCAE v5.0, clinical laboratory test results, ECGs, Vital signs and DLT criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy,phamacokinetics To evaluate preliminarry efficacy based on RECIST v1.1. To evaluate PK profile of AQUA07 through assessment of plasma AQUA07 concentration. To evaluate PK profile of AQUA07 when administered in combination with lorlatinib. To evaluate PK profile of lorlatinib when administered in combination with AQUA07. | — |
Countries
Japan, United States of America
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed