D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InventisBio Co., Ltd; InventisBio Inc.

Criteria

Inclusion Criteria:

• Aged at least 18 years.

• Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.

• Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib.

• patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI.

• Eastern cooperative oncology group performance status (ECOG PS) of 0-1.

• a minimum life expectancy of 12 weeks.

• At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.1.

• Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period.

Exclusion Criteria:

• Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI.

• Unresolved toxicities from prior therapy.

• Unstable spinal cord compression/brain metastases.

• Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.

• QTcF≥470 msec（female）or QTcF≥450 msec（male）during the screening period.

• Severe respiratory diseases such as interstitial lung disease, severe asthma, pulmonary embolism, etc.

• previous treatment with 2 or more lines of Chemotherapy or immunotherapy.