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.
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
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), EGFR, Neoadjuvant Therapy
- 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
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)
Show all 9Show fewer
- 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
Show all 13Show fewer
- 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.
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 group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Firmonertinib 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.
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)
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
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
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
Overall Survival (OS)
Patients alive after study enrollment
Measured: Through study completion, an average of 4 years
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.
- First posted8 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Wang, Hubei Cancer Hospital
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