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Non Small Cell Lung CancerPhase 2NCT04438902

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

A Phase 2 study testing osimertinib mesylate tablets and anlotinib hydrochloride capsules in people with Non Small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
osimertinib mesylate tablets and anlotinib hydrochloride capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesChina
Study dates
12 Dec 2020to 16 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Jiaxing College

    Jiaxing, Zhejiang, 314001

Other trials in China

About this study

Official title: A Prospective, Multi-center, Interventional Study of Osimertinib Combined With Anlotinib in Acquired EGFR T790M Mutated NSCLC Patients With Gradual Progression on Osimertinib Treatment

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.

Read the detailed description

In current clinical practice, acquired resistance to osimertinib can be divided into three clinical modes: dramatic progression, gradual progression and local progression. For patients with gradual progression,there are various clinical explorations，including the continuation of osimertinib with chemotherapy or radiotherapy, osimertinib combined with antiangiogenic agents. In preclinical studies, an overactive vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) pathway and tumour angiogenesis plays a crucial role in the resistance to EGFR-TKIs, and the dual targeting of both the VEGF and EGFR pathways may prevent resistance.

Anlotinib (AL3818) is an inhibitor targeting multiple receptor tyrosine kinases involved in tumour progression, especially VEGFR 2/3, PDGFRα/β and c-Kit. We suppose that the combination treatment of osimertinib and anlotinib may ameliorate acquired resistance to osimertinib.This is a multi-center, open, single-arm, exploratory phase 2 trial evaluating osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.

Being tested
osimertinib mesylate tablets and anlotinib hydrochloride capsules
Keywords
non-small-cell lung cancer, EGFR T790M, osimertinib, anlotinib, acquired resistance
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • osimertinib mesylate tablets and anlotinib hydrochloride capsulesDrug

    Also called TAGRISSO and FOCUS V

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

Study groups in NCT04438902
Study groupRoleWhat they receive
osimertinib combined with anlotinibExperimentalNot described
Receives: Drug: osimertinib mesylate tablets and anlotinib hydrochloride capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR), is defined as the percentage of patients with complete response or partial response by investigator assessment as recorded in the CRF, which usually refer to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 in clinical practice.

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

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR), is defined as the percentage of patients with complete response or partial response or stable disease by investigator assessment as recorded in the CRF, which usually refer to RECIST v1.1 in clinical practice.

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

  3. Adverse events/Serious adverse events

    Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start12 Dec 2020
  3. Primary completion8 Dec 2022
  4. Study completion16 Feb 2023

Why it stopped: Many patients can't tolerate the combination treatment due to adverse events.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a multi-center, open, single-arm, exploratory phase 2 trial.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04438902
Sponsor's protocol ID
TRAIN
Status last verified
Jun 2021
First submitted
15 Jun 2020
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share participant data of the trial.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing osimertinib mesylate tablets and anlotinib hydrochloride capsules in people with Non Small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Many patients can't tolerate the combination treatment due to adverse events.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (PFS) (time frame: from the date of first dose of osimertinib until the date of disease progression，assessed up to 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04438902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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