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Non-Small-Cell Lung CancerPhase 2FOCUS-ANCT04895930

Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC

A Phase 2 study testing Furmonertinib and Anlotinib in people with Non-Small-Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib combined with Anlotinib as the first-line treatment in locally advanced or metastatic non-small cell lung cancer with sensitive EGFR mutations. 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?
Furmonertinib and Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
12 Oct 2021to 30 Nov 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

  • Subjects have voluntarily participated, signed and dated informed consent;
  • Male or female subjects aged ≥18 and ≤75 years old;
  • Locally advanced or metastatic adenocarcinoma NSCLC confirmed by histology or cytology (according to the 8th Edition of the AJCC Staging system), not suitable for surgery or radiotherapy;
  • ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment;
  • The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
  • According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously;
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  • No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC. For recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs ≥6 months from stopping treatment;
  • Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment;
  • For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

Who cannot join

  • Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc;
  • Subjects are expected to participate in other clinical studies during this trial period;
  • Imaging evidence showed that the tumor had invaded critical blood vessels;
  • Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously;
  • With other malignant tumors at present or history of other malignant tumors within 5 years;
  • Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;
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  • At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1;
  • History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors;
  • Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs;
  • Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation;
  • Presence of bleeding constitution or active bleeding; any bleeding event ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures occurred within 28 days prior to the first dose;
  • Any of the following organ function criteria is met (no blood or blood product transfusions, no hematopoietic stimulating factors, no albumin or blood product transfusions within 7 days prior to examination): Absolute value of neutrophil (NE)<1.5 × 109/L, platelet (PLT) count<90 × 109/L, hemoglobin (HGB)<90 g/L; Serum total bilirubin (TBIL)>1.5 × ULN, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN (for liver metastases or Gilbert Syndrome, TBIL>3 × ULN, and AST and/or ALT>5 × ULN); Serum creatinine (SCr)>1.5 × ULN, or creatinine clearance<60ml/min. (According to the Cockcroft and Gault formula); Urinary protein ≥ ++, or 24-hour urine protein>1.0g; International normalized ratio（INR）>1.5 and activated partial thromboplastin time (APTT)>1.5 ULN; Fasting blood glucose >10mmol/L；
  • Any of the following cardiac criteria is met：
  • At rest, the mean corrected QT interval (QTc) by ECG > 470 msec；
  • Seriously abnormal of heart rhythm, conduction, or morphology of resting ECG;
  • Any factors that may increase the risk of prolonged QTc or risk of arrhythmic events;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Uncontrollable hypertension (systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥100 mmHg);
  • With active infection diseases, such as HBV, HCV and HIV;
  • Known or suspected to be allergic to Furmonertinib and Anlotinib and / or other components of their preparations;
  • Pregnancy or lactation;
  • Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

Trial locations and contacts

1 site in 1 country.

Baohui Han, MD contact

+86 021-22200000

xkyyhan@gmail.com

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200000

    Baohui Han

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, One-arm Clinical Trial of Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC.

The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib combined with Anlotinib as the first-line treatment in locally advanced or metastatic non-small cell lung cancer with sensitive EGFR mutations.

Being tested
Furmonertinib, Anlotinib
Keywords
EGFR mutations; furmonertinib; anlotinib; non-squamous NSCLC
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.

  • FurmonertinibDrug

    Also called AST2818

    80mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (40mg).

  • AnlotinibDrug

    10mg/day orally from day 1 to 14 of a 21-day cycle. If subjects suffer from AEs, they can get declined dosage (8mg).

Study groups in NCT04895930
Study groupRoleWhat they receive
Furmonertinib Plus AnlotinibExperimentalFurmonertinib (80mg) plus Anlotinib (10mg)
Receives: Drug: Furmonertinib; Drug: Anlotinib

What is being measured

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

  1. Objective Response Rate (ORR)

    Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.

    Measured: Approximately 3 years following the first dose of study drugs

Secondary outcomes (4)

  1. Disease Control Rate (DCR)

    Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1.

    Measured: Approximately 3 years following the first dose of study drugs

  2. Duration of Response (DOR)

    The time from objective tumor remission (CR or PR) to the progression of the disease or death for any reason.

    Measured: Approximately 3 years following the first dose of study drugs

  3. Disease progression free survival (PFS)

    The time from the first does of the study drugs to the progression of the disease or death for any reason.

    Measured: Approximately 3 years following the first dose of study drugs

  4. Adverse Events

    Number of participants with adverse events as a measure of safety and tolerability.

    Measured: Until 30 days from the last dose of study drugs or initiation of a new anticancer treatment

Timeline

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

  1. First posted20 May 2021
  2. Study start12 Oct 2021
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

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
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895930
Sponsor's protocol ID
AST-PMR2002
Acronym
FOCUS-A
Status last verified
Jan 2023
First submitted
19 May 2021
Last updated
6 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shi Y, Hu X, Zhang S, Lv D, Wu L, Yu Q, Zhang Y, Liu L, Wang X, Cheng Y, Ma Z, Niu H, Wang D, Feng J, Huang C, Liu C, Zhao H, Li J, Zhang X, Jiang Y, Gu C. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. 2021 Aug;9(8):829-839. doi: 10.1016/S2213-2600(20)30455-0. Epub 2021 Mar 26.

    PubMed 33780662

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib and Anlotinib in people with Non-Small-Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site 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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Baohui Han, MD (+86 021-22200000, xkyyhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Approximately 3 years following the first dose of study drugs). 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 NCT04895930, which also lists 1 linked publication.

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 6 Jan 2023.

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