Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment

NCT04438902 | Terminated Phase 2

• 1 other identifier: TRAIN
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

EGFR T790M gatekeeper mutation accounts for approximately 60% of acquired resistance to the first- or second-generation EGFR-TKI treatment. Osimertinib, a third-generation EGFR TKI, has become the standard therapy for NSCLC patients with acquired EGFR T790M mutation. However, acquired resistance to osimertinib is still inevitable and there is no established targetable agent currently. Thus, treatment strategy for patients with acquire resistance to osimertinib remains an urgent issue. In this study, we aimed to evaluate the efficacy of osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.

Conditions

Non Small Cell Lung Cancer

Keywords

non-small-cell lung cancer; EGFR T790M; osimertinib; anlotinib; acquired resistance

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  PFS is defined as the time from beginning of osimertinib to disease progression on combination treatment of osimertinib and anlotinib.

  from the date of first dose of osimertinib until the date of disease progression，assessed up to 12 months.

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.

• Disease Control Rate (DCR)

  from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.

• Adverse events/Serious adverse events

  From signing ICF to 30 days after the end of treatment.

Study Arms (1)

osimertinib combined with anlotinib

EXPERIMENTAL

Drug: osimertinib mesylate tablets and anlotinib hydrochloride capsules

Interventions

osimertinib mesylate tablets and anlotinib hydrochloride capsules DRUG

osimertinib mesylate tablets 80mg qd and anlotinib hydrochloride capsules 10mg qd day 1-14 of a 21-day cycle

Also known as: TAGRISSO and FOCUS V

osimertinib combined with anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent, complete all study assessments and have complete medical record.
• Age:18-75 years.
• Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC.
• Patients should be confirmed acquired EGFR T790M mutation and received osimertinib as the second line treatment, and they should have the following: (1) benefit from treatment with osimertinib initially ;(2) gradual progression on osimertinib treatment as defined by minor increment of tumor burden (≥10% but \<20% in the sum of target lesions).
• At least one measurable lesion as defined by lesions ≥10mm in long axis according to RECIST 1.1.

You may not qualify if:

• Patients who will be or were involved in any other interventional antitumour clinical studies for locally advanced/metastatic NSCLC currently or previously.
• Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer).
• Patients at risk of bleeding.
• Patients with renal dysfunction.
• Uncontrolled severe hypertension.
• Any concomitant condition evaluated by physicians which is not suitable for osimertinib or anlotinib treatment.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (2)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

The First Affiliated Hospital of Jiaxing College

Jiaxing, Zhejiang, 314001, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuehong Wang

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center, open, single-arm, exploratory phase 2 trial.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: December 12, 2020
• Primary Completion: December 8, 2022
• Study Completion: February 16, 2023
• Last Updated: February 21, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)