Clinical Trials Logo

Clinical Trial Summary

This is a prospective, single arm, phase Ib/IIa study. Up to 25 patients will be enrolled into the study (Part A: 2-18; Part B: 7-19). The study has been designed to allow an investigation of the optimal combination dose and schedule whilst of Osimertinib plus Anlotinib in patients with EGFRm+, treatment-naïve IIIb/IV Non-Small Cell Lung Cancer (NSCLC) ensuring the safety of patients with intensive safety monitoring. There are two main parts to this study; Part A, Combination dose finding and Parts B, Dose expansion.


Clinical Trial Description

Part A has been designed to identify the recommended dose of the combination of Osimertinib plus Anlotinib for further clinical evaluation based upon assessment of the safety and tolerability data collected during the first 21 days (cycle 1, 21 days per cycle). A cycle of study treatment will be defined as 21 days. Dosing will begin at Osimertinib 80mg QD continuously and Anlotinib 8mg QD from day1 to 14 of a 21-day cycle. In the first 6 patients, a delay of at least 21 days (the first group of 3 patients) and a delay of at least 7 days (the second group of 3 patients) will be mandatory between the administration of the first dose to the first patient and administration of first dose to subsequent patients. Patients will be enrolled to ensure a minimum of 3 and a maximum of 6 evaluable patients per cohort. Dose escalation and de-escalation will follow the scheme below, according to the following logic:If no dose-limiting toxicity (DLT) is observed (for definition see Section 4.1.3) in a cohort of 3 evaluable patients then dose escalation may occur. Dose increases will be permitted after review of data from a minimum of 3 evaluable patients has been performed. - If one patient experiences a DLT in a group of 3 evaluable patients then the cohort will be expanded to include 6 evaluable patients. If only one DLT is observed in the complete cohort of 6 evaluable patients then dose escalation may occur. - If 2 or more patients experience a DLT in a group of up to 6 patients, irrespective of the number of patients enrolled, the dose will be considered not tolerated and recruitment to the cohort and dose escalation will cease. Safety will be intensively monitored in part A. If RP2D was not reached in Part A, Part B would not be initiated. If RP2D was reached in Part A, eligible patients in part B will be enrolled and receive Osimertinib (80mg QD, continuously) plus Anlotinib (RP2D, QD from day 1 to 14 of a 21-day cycle) till disease progression (PD) or unacceptable toxicity, with the aim to further evaluate the safety, tolerability and efficacy in terms of ORR, DCR, DOR, PFS, overall survival at 12 months. For all eligible patients (Part A and Part B), tissue and/or blood samples at baseline and PD will be collected to understand the resistance profile. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04770688
Study type Interventional
Source Shanghai Chest Hospital
Contact Baohui Han, DR.
Phone 13817833343
Email hanxkyy@aliyun.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 19, 2020
Completion date November 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Recruiting NCT05798611 - Study of ART0380 in Patients With Biologically Selected Solid Tumors Phase 2
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT05036681 - A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma Phase 2
Withdrawn NCT00005030 - SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver Phase 1
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Recruiting NCT04085029 - Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Not yet recruiting NCT05981170 - Rurality Adapted Physical Activity Sport Health
Not yet recruiting NCT03058809 - Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood Phase 1/Phase 2
Completed NCT02529553 - A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Phase 1
Terminated NCT01929941 - An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies Phase 1
Completed NCT01302808 - Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Phase 1
Terminated NCT00918645 - Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis N/A
Completed NCT00795678 - Chemotherapeutic Agents in Brain/Breast N/A
Withdrawn NCT00769990 - Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases Phase 1/Phase 2
Completed NCT00557102 - Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung Phase 2
Recruiting NCT00398437 - Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer N/A