AzTrials
AzTrials

Lung Adenocarcinoma Stage IIIPhase 2NCT05503667

Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma

A Phase 2 study testing Furmonertinib and Bevacizumab in people with Lung Adenocarcinoma Stage III and Lung Adenocarcinoma Stage IV, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To explore the efficacy and safety of neoadjuvant furmonertinib combined with bevacizumab in the treatment of resectable and potentially resectable stage III-IVA EGFR mutation-positive lung adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Furmonertinib and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteChina
Study dates
1 Feb 2022to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;
  • At stage III-IVA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
  • No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
  • With the feasiblility or potential feasibility to receive radical surgery (radical lung lobectomy+systematic lymph node dissection);
  • Good lung function that could tolerate surgical treatment;
  • Aged >= 18 years;
Show all 11Show fewer
  • At least one measurable tumor foci (the longest diameter measured by CT shall be > 10 mm);
  • Other major organs shall function well (liver, kidney, blood system, etc.):
  • ECOG PS score shall be 0-1;
  • The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
  • The patient shall sign the Informed Consent Form.

Who cannot join

  • The patient has undergone any systemic anti-cancer treatment for NSCLC, including cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
  • The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
  • The patient is a carrier of HIV;
  • The patient is currently suffering from interstitial lung disease;
  • The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
  • The patient is allergic to furmonertinib or its any excipients;
Show all 9Show fewer
  • The patient is allergic to bevacizumab or its any excipients;
  • The female patient is in pregnancy or lactation period;
  • There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peng Zhang, MD,PhD contact

+8613512185932

zhangpeng1121@outlook.com

China1 site, 1 recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Peng Zhang, MD,PhD, zhangpeng1121@outlook.com

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma: A Randomized, Controlled, Open-label, Single-center Phase II Clinical Trial

To explore the efficacy and safety of neoadjuvant furmonertinib combined with bevacizumab in the treatment of resectable and potentially resectable stage III-IVA EGFR mutation-positive lung adenocarcinoma.

Read the detailed description

The best treatment for lung cancer is still radical resection, which is indicated for stage I-II and some stage III patients, but surgery is only suitable for 20-25% of NSCLC patients. Furmonertinib is a third-generation TKI drug. Compared with first and second-generation TKI drugs, it has good benefits in the Chinese population, patients with brain metastases, and patients with 19del/L858R mutation, with better and longer-lasting effects, and can significantly improve the progression-free survival of patients. Neoadjuvant therapy can shrink the tumor, increase the rate of complete surgical resection, remove micrometastases, and reduce the risk of recurrence. Cases of patients with locally advanced (IIIA-N2) NSCLC have been reported with neoadjuvant TKI therapy, and it has been found that neoadjuvant TKI therapy can downgrade or even complete tumor remission. However, for locally advanced potentially resectable, or EGFR mutation-positive NSCLC patients with single-organ metastasis, the efficacy of third-generation EGFR-TKI combined with VEFGR inhibitor combined with targeted therapy after induction and surgery is still unclear. Limited clinical research data suggest that this new treatment mode (induction therapy-surgery-adjuvant therapy) can significantly improve the progression-free survival of patients. However, the overall survival rate under the new treatment mode and the promotion of clinical work urgently need higher-level clinical evidence to support clinical decision-making.

Being tested
Furmonertinib, Bevacizumab
Keywords
neoadjuvant chemoimmunotherapy
Medical subject headings
Adenocarcinoma of Lung

What participants receive

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

  • FurmonertinibDrug

    Also called Ivesa

    Furmonertinib 80 mg/day for 16 weeks

  • BevacizumabDrug

    Also called Avastin

    bevacizumab 400 mg/4 weeks i.v. for 4 times

Study groups in NCT05503667
Study groupRoleWhat they receive
Furmonertinib Plus BevacizumabExperimentalFurmonertinib Plus Bevacizumab
Receives: Drug: Furmonertinib; Drug: Bevacizumab
FurmonertinibActive comparatorFurmonertinib monotherapy
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)

    It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.

    Measured: up to 21 months

Secondary outcomes (8)

  1. Disease-free survival (DFS)

    It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).

    Measured: up to 54 months

  2. Overall survival (OS)

    It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).

    Measured: up to 60 months

  3. Health related quality of life (HRQol)

    The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.

    Measured: up to 6 months

  4. Progression-free survival (PFS)

    It refers to the time from the first administration of SHR1316 in this study to the disease progression or death (including any cause of death in the case of no progression) , regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

    Measured: up to 54 months

  5. R0 resection

    It is defined as the proportion of patients with negative surgical margin and no residual found under microscope after resection in all patients who have completed the treatment.

    Measured: up to 24 months

  6. Pathological downstaging rate

    It is defined as the proportion of patients who have completed the 8-week treatment with afatinib before operation and have achieved a T stage downing of the tumor as confirmed by CT evaluation after 3 weeks in all patients who have completed the treatment.

    Measured: up to 24 months

  7. Treatment-related adverse events (AEs)

    It refers to the number of adverse events related to furmonertinib plus bevacizumab therapy or furmonertinib monotherapy as evaluated according to CTCAE v4.0.

    Measured: up to 6 months

  8. Pathological complete response rate (pCR)

    It refers to the number of cases with no residual invasive cancer in the primary tumor and lymph node HE staining accounted for the proportion of all patients who completed the treatment.

    Measured: up to 24 months

Timeline

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

  1. First posted17 Aug 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion31 Dec 2028 (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
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503667
Sponsor's protocol ID
LungMate-012
Status last verified
Aug 2022
First submitted
13 Aug 2022
Last updated
17 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib and Bevacizumab in people with Lung Adenocarcinoma Stage III and Lung Adenocarcinoma Stage IV, run by Shanghai Pulmonary Hospital, Shanghai, China 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Aug 2022. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Peng Zhang, MD,PhD (+8613512185932, zhangpeng1121@outlook.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: up to 21 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 NCT05503667.

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 17 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in