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

NCT07807722 | Not Yet Recruiting Phase 2

• 1 other identifier: LCKY2026007
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

NSCLC (Non-small Cell Lung Cancer); EGFR; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (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.

  At the time of definitive surgery

Secondary Outcomes (5)

• pCR rate

  At the time of definitive surgery

• Complete resection rate (R0 resection)

  At the time of definitive surgery

• Event-Free Survival (EFS)

  Through study completion, an average of 4 years

• Overall Survival (OS)

  Through study completion, an average of 4 years

• AE

  From the first dose of study treatment up to 30 days after the last dose of study treatment

Study Arms (1)

Experimental Group

EXPERIMENTAL

Firmonertinib combined with anlotinib and chemotherapy

Drug: Firmonertinib combined anlotinib and chemotehrapy

Interventions

Firmonertinib combined anlotinib and chemotehrapy DRUG

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Other major organs (liver, kidney, blood system, etc.) are functioning normally:
• ）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.
• \. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sheng Wang

CONTACT

15871415599; wangshenghbch@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physicians

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 8, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 8, 2026

Record last verified: 2026-08

Locations

CN (1)