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

September 3, 2026 updated by: Sheng Wang, Hubei Cancer Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Cancer Hospital
        • Contact:
          • Sheng Wang
          • Phone Number: 15871415599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. EGFR mutation positive non-small cell lung cancer (including 19Del and 21L858R) confirmed by biopsy
  2. Resectable stage IIA-IIIB (8th edition TNM staging) non-small cell lung cancer diagnosed by chest CT, PET-CT, or/and EBUS
  3. No systemic metastasis (head MRI, whole-body bone scan PET-CT、 Liver and adrenal CT scans, etc
  4. Good lung function, able to tolerate surgical treatment
  5. Age 18 and above
  6. At least one measurable tumor lesion (with a maximum diameter of 10mm or more as measured by CT)
  7. 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

Exclusion Criteria:

  1. 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
  2. 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
  3. 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)
  4. The patient is an active hepatitis B, hepatitis C or HIV carrier
  5. Severe or newly diagnosed gastrointestinal disease patients with diarrhea as the main symptom
  6. The patient is receiving treatment with P-glycoprotein inhibitors
  7. Individuals who have previously suffered or are currently suffering from cardiovascular malformations
  8. The patient has previously suffered from or is currently suffering from interstitial lung disease
  9. The patient has undergone other major systemic surgeries or suffered severe trauma within the 3 months prior to the trial
  10. Suffering from neurological or psychiatric disorders
  11. The patient has malabsorption
  12. Female patients in pregnancy or lactation period
  13. Other researchers believe that patients are not suitable for inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Firmonertinib combined with anlotinib and chemotherapy
Drug: Firmonertinib combined anlotinib and chemotehrapy
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MPR rate
Time Frame: At the time of definitive surgery
The proportion of patients with ≤10% residual viable tumor cells in the primary tumor, as assessed by histopathological examination of the resected surgical specimen.
At the time of definitive surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete resection rate (R0 resection)
Time Frame: At the time of definitive surgery
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.
At the time of definitive surgery
pCR rate
Time Frame: At the time of definitive surgery
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.
At the time of definitive surgery
Event-Free Survival (EFS)
Time Frame: Through study completion, an average of 4 years
Patients alive and free from disease recurrence, progression, or death from any cause after study enrollment
Through study completion, an average of 4 years
Overall Survival (OS)
Time Frame: Through study completion, an average of 4 years
Patients alive after study enrollment
Through study completion, an average of 4 years
AE
Time Frame: From the first dose of study treatment up to 30 days after the last dose of study treatment
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.
From the first dose of study treatment up to 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hubei Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCKY2026007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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