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Non-Small Cell Lung CancerPhase 2NCT06394674

High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib

A Phase 2 study testing Furmonertinib in people with Non-Small Cell Lung Cancer, run by Changhai 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and… 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
1 May 2024to Sep 2026
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

  • Histologically or cytologically confirmed metastatic lung adenocarcinoma
  • Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
  • Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
  • Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration >6 months);
  • Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
  • Normal functioning of major organs
  • Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
  • Subjects volunteered and signed a written informed consent form.

Who cannot join

  • Previous chemotherapy or immunotherapy
  • Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
  • Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
  • Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
  • Any unrecovered CTCAE > grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
  • Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
  • History of interstitial pneumonia with previous diagnosis
  • Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Changhai Hospital

    Shanghai

    Yuchao Dong, 021-31166666, dongyc1020@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.

Being tested
Furmonertinib
Keywords
furmonertinib
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

    Drug: Furmonertinib

Study groups in NCT06394674
Study groupRoleWhat they receive
Group A: Furmonertinib 160mg QDExperimentalFurmonertinib (AST2818) 160mg QD. All patients enrolled into this group will receive furmonertinib 160mg daily.
Receives: Drug: Furmonertinib
Group B: Furmonertinib 240mg QDExperimentalFurmonertinib (AST2818) 240mg QD. All patients enrolled into this group will receive furmonertinib 240mg daily.
Receives: Drug: Furmonertinib

What is being measured

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

  1. Objective Response Rate(ORR)

    Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response

    Measured: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.

    Measured: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment

  2. Disease Control Rate (DCR)

    Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator.

    Measured: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment

  3. Duration of Response (DoR)

    Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

    Measured: Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 12 months from the first patient begin study treatment

Timeline

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

  1. First posted1 May 2024
  2. Study start1 May 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionSep 2026 (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
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06394674
Sponsor's protocol ID
CHEC2023-155
Status last verified
May 2024
First submitted
27 Apr 2024
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib in people with Non-Small Cell Lung Cancer, run by Changhai 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 8 inclusion and 8 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 26 Jul 2024. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment). 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 NCT06394674.

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 26 Jul 2024.

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