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NSCLC (Non-small Cell Lung Cancer)Phase 2NCT07807722

Neoadjuvant Therapy With Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy for Resectable EGFR-Mutated NSCLC

A Phase 2 study testing Firmonertinib combined anlotinib and chemotehrapy in people with NSCLC (Non-small Cell Lung Cancer) and EGFR, run by Hubei Cancer Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Exploring the efficacy and safety of firmonertinib combined with anlotinib and platinum-based doublet chemotherapy as neoadjuvant therapy in patients with EGFR-mutant resectable NSCLC Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Firmonertinib combined anlotinib and chemotehrapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
21 Sep 2026to Sep 2030
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • EGFR mutation positive non-small cell lung cancer (including 19Del and 21L858R) confirmed by biopsy
  • Resectable stage IIA-IIIB (8th edition TNM staging) non-small cell lung cancer diagnosed by chest CT, PET-CT, or/and EBUS
  • No systemic metastasis (head MRI, whole-body bone scan PET-CT、 Liver and adrenal CT scans, etc
  • Good lung function, able to tolerate surgical treatment
  • Age 18 and above
  • At least one measurable tumor lesion (with a maximum diameter of 10mm or more as measured by CT)
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  • Other major organs (liver, kidney, blood system, etc.) are functioning normally:
  • 1）Hemoglobin ≥ 9.0 g/dL (or can be maintained through blood transfusion or exceed this standard) 2）Red blood cell count ≥ 2.0 × 10^9/L 3）Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L 4）Platelet count ≥ 100 × 10^9/L 5）Total bilirubin is within the normal range 6）Alanine transaminase, aspartate transaminase, and alkaline phosphatase ≤ 2.5 times the upper limit of normal values 7）Creatinine ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60ml/min 8）The international normalized ratio (INR) of prothrombin time to activated partial thromboplastin time for patients who have not received anticoagulant therapy is ≤ 1.5 times the upper limit of normal. Patients who have received comprehensive or intravenous anticoagulant therapy can only participate in clinical trials if the dosage of anticoagulant drugs is stable for more than 2 weeks and the coagulation test results are within the local treatment range.
  • 8. ECOG PS score is 0-1 9. Women of childbearing age must undergo a pregnancy test within 7 days before treatment, and the result is negative. During the trial period and within 30 days after the end of the trial, reliable contraceptive measures such as intrauterine devices, birth control pills, condoms, etc. should be taken. During the trial period and within 30 days after the end of the trial, men of childbearing age should use condoms for contraception; 10. Patients should sign an informed consent form

Who cannot join

  • The patient has received systemic anti-cancer treatment for non-small cell lung cancer, including surgical treatment, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, etc
  • Patients with other cancers (excluding cervical cancer in situ, cured basal cell carcinoma, and bladder epithelial tumors [including Ta and Tis]) within the 5 years prior to the trial, unless they have small cell lung cancer
  • The patient has any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina that has started to occur in the past 3 months, congestive heart failure [≥ NYHA Grade II], myocardial infarction (6 months prior to enrollment), severe arrhythmia, and liver, kidney, or metabolic diseases that require medication treatment)
  • The patient is an active hepatitis B, hepatitis C or HIV carrier
  • Severe or newly diagnosed gastrointestinal disease patients with diarrhea as the main symptom
  • The patient is receiving treatment with P-glycoprotein inhibitors
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  • Individuals who have previously suffered or are currently suffering from cardiovascular malformations
  • The patient has previously suffered from or is currently suffering from interstitial lung disease
  • The patient has undergone other major systemic surgeries or suffered severe trauma within the 3 months prior to the trial
  • Suffering from neurological or psychiatric disorders
  • The patient has malabsorption
  • Female patients in pregnancy or lactation period
  • Other researchers believe that patients are not suitable for inclusion in the study

Trial locations and contacts

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

Sheng Wang contact

15871415599

wangshenghbch@163.com

China1 site

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Sheng Wang, 15871415599

Other trials in China

About this study

Official title: Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy in Patients With EGFR-mutant Resectable NSCLC : A Prospective, Multicenter, Single Arm, Phase II Exploratory Clinical Study

Exploring the efficacy and safety of firmonertinib combined with anlotinib and platinum-based doublet chemotherapy as neoadjuvant therapy in patients with EGFR-mutant resectable NSCLC

Read the detailed description

Multiple ongoing clinical trials are investigating the efficacy and safety of the new generation EGFR-TKI in neoadjuvant therapy. The research on neoadjuvant targeted therapy is still in its early stages, and the optimal treatment time is still unclear. Additional data from ongoing clinical trials will be crucial in determining the optimal duration of neoadjuvant targeted therapy. Compared with neoadjuvant immunotherapy, preliminary data suggest that the MPR or pathological complete response (pCR) rate of neoadjuvant targeted therapy may be lower, while other efficacy endpoints (R0 resection rate, reduction in progression, Event Free Survival (EFS), DFS, PFS) are comparable.

Firmonertinib is a third-generation EGFR-TKI developed by Shanghai Ailisi Pharmaceutical Technology Co., Ltd. It can simultaneously target EGFR sensitive mutations and Thr790Met mutations [37]. FURLONG research has shown that in the first-line treatment of EGFR mutation positive NSCLC patients in China, fumatinib is superior to first generation EGFR-TKI gefitinib in terms of PFS, and patients have better tolerance. This benefit is consistent in most pre-designated subgroups, including patients with central nervous system metastases.

Anlotinib is a small molecule multi-target TKI independently developed by China Zhengda Tianqing Pharmaceutical Group Co., Ltd. It can effectively inhibit kinases such as VEGFR, PDGFR, FGFR, and c-Kit, and has anti-tumor angiogenesis and tumor growth inhibition effects. The oral presentation of the FLALTER study at the 2022 European Society for Medical Oncology (ESMO) annual meeting showed that the combination of anlotinib and gefitinib significantly prolonged the median progression free survival (PFS) of patients with metastatic EGFR mutant NSCLC compared to the gefitinib monotherapy group.

The preliminary results of multiple ongoing clinical trials indicate that the ORR of anlotinib combined with third-generation EGFR-TKI for the treatment of EGFR mutant advanced NSCLC ranges from 65.20% to 96.15%, demonstrating the enormous potential of the combination therapy. The aim of this study is to investigate the efficacy and safety of neoadjuvant firmonertinib combined with anlotinib and chemotherapy in the treatment of resectable EGFR mutation positive NSCLC.

Being tested
Firmonertinib combined anlotinib and chemotehrapy
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.

  • Firmonertinib combined anlotinib and chemotehrapyDrug

    EGFR-TKI: Firmonertinib 80mg daily Antiangiogenic drugs: Anlotinib 8-12mg daily, D1-14 and of 21-day cycles Chemotherapy: pemetrexed plus carboplatin on Day 1 and of 21-day cycles (every 3 weeks) for 3 cycles

Study groups in NCT07807722
Study groupRoleWhat they receive
Experimental GroupExperimentalFirmonertinib combined with anlotinib and chemotherapy
Receives: Drug: Firmonertinib combined anlotinib and chemotehrapy

What is being measured

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

  1. MPR rate

    The proportion of patients with ≤10% residual viable tumor cells in the primary tumor, as assessed by histopathological examination of the resected surgical specimen.

    Measured: At the time of definitive surgery

Secondary outcomes (5)

  1. pCR rate

    The proportion of patients with no residual invasive tumor in the primary tumor and all sampled lymph nodes, as assessed by histopathological examination of the resected surgical specimen.

    Measured: At the time of definitive surgery

  2. Complete resection rate (R0 resection)

    The proportion of patients who achieve a complete (R0) resection of all known disease, as determined by the surgeon and pathologist at the time of definitive surgical resection.

    Measured: At the time of definitive surgery

  3. Event-Free Survival (EFS)

    Patients alive and free from disease recurrence, progression, or death from any cause after study enrollment

    Measured: Through study completion, an average of 4 years

  4. Overall Survival (OS)

    Patients alive after study enrollment

    Measured: Through study completion, an average of 4 years

  5. AE

    The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From the first dose of study treatment up to 30 days after the last dose of 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 posted8 Sep 2026
  2. Study start21 Sep 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionSep 2030 (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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807722
Sponsor's protocol ID
LCKY2026007
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Firmonertinib combined anlotinib and chemotehrapy in people with NSCLC (Non-small Cell Lung Cancer) and EGFR, run by Hubei Cancer 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 13 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: opening soon, as of the sponsor's last update on 8 Sep 2026. 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 Sheng Wang (15871415599, wangshenghbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR rate (time frame: At the time of definitive surgery). 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 NCT07807722.

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 8 Sep 2026.

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