Furmonertinib Combined With Local Therapy in Inoperable or Surgery-Refusing Early-Stage Non-Small Cell Lung Cancer:A Single-arm, Phase II Study

Plain English Summary

Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial is a Phase 2 clinical trial sponsored by Shanghai Pulmonary Hospital, Shanghai, China studying Non-small Cell Lung Cancer. This trial tests a new drug called furmonertinib along with local treatments like ablation or radiation for early-stage lung cancer. It is for patients with inoperable or surgery-refusing early-stage non-small cell lung cancer who have specific genetic mutations. Participation involves taking furmonertinib daily for 3 years and undergoing local therapy (ablation or radiation). Alternatives may include standard chemotherapy, immunotherapy, or other targeted therapies depending on the specific cancer. The trial aims to enroll 45 participants.

Official Summary

The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery. The main purposes of this study is to answer: Can ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients aged 18 or older with early-stage non-small cell lung cancer (NSCLC) that has not spread. Must have specific EGFR gene mutations (like Exon 19 deletion or L858R) confirmed by genetic testing. Patients must be medically unable to have surgery or choose not to have it. Cannot have had recent radiation therapy, major surgery, or be currently participating in another trial. This trial is studying Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how many patients are still alive and free from cancer progression for at least two years, indicating the treatment's effectiveness in controlling the disease. The specific primary outcome measures are: 2-year EFS rate (Within two years after the treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to fill a treatment gap for early-stage lung cancer patients who cannot undergo surgery by exploring a combination therapy that may improve outcomes. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial focuses on a specific subset of lung cancer patients, potentially opening a new treatment avenue if successful, which could represent a significant market opportunity for furmonertinib. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your specific lung cancer has the required EGFR mutations. Understand the daily commitment of taking furmonertinib for three years and the potential side effects of local therapies. Discuss how this treatment might affect your daily life and any necessary follow-up appointments. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 45 participants

Interventions

• DRUG: furmonertinib — furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years
• PROCEDURE: ablation — 1. Immobilization and image guidance: Supine or prone position; vacuum cushion or mask to limit motion. CT guidance for entry point, angle, and depth; ultrasound for selected peripheral lesions. 2. Ablation target planning: Ablation zone should cover GTV with ≥5-10 mm margin. For tumors near critical structures, pursue adequate margin when safe; consider heat sink or thermal isolation. 3. Ablation procedure: Choose MWA, RFA, or cryoablation based on tumor size, location, anatomy, and resources.
• RADIATION: stereotactic body radiotherapy — 1. Immobilization: Use a thermoplastic mask or vacuum cushion for immobilization based on the treatment site. 2. CT simulation: After immobilization and stabilization of breathing, laser alignment is performed, followed by 4D-CT simulation (preferred) or conventional CT simulation. 3. Radiotherapy target delineation and dose: GTV includes the primary lung tumor and metastatic lymph nodes after chemotherapy. A 5-mm margin is added to form the PTV. 4. Radiotherapy plan: For peripheral lesions: 48

Primary Outcomes

• 2-year EFS rate (Within two years after the treatment)

Secondary Outcomes

• 3-year EFS rate (Within three years after the treatment)
• overall survival (through study completion, an average of 5 year)
• Local control rate (LCR) (through study completion, an average of 1 year)
• Time to distant metastasis (through study completion, an average of 1 year)

Full Eligibility Criteria

Inclusion Criteria:

* Voluntarily participate in the clinical study
* Aged ≥ 18 years at the time of signing the informed consent form
* Histologically or cytologically confirmed early-stage T1-3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence
* Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations
* ECOG performance status score of 0-2
* Deemed medically inoperable or refuse surgery after multidisciplinary evaluation
* Pulmonary lesions suitable for ablation or radiotherapy (either modality)
* Adequate major organ function

Exclusion Criteria:

* Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug
* Known contraindications to ablation or radiotherapy
* Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan
* Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose
* Patients with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV-RNA indicating viral replication)
* Receipt of curative-intent radiotherapy within 3 months prior to the first dose
* Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered)
* Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer
* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

Trial Locations

• Shanghai Pulmonary Hospital, Shanghai, China

Frequently Asked Questions

Related Conditions

• Non-small Cell Lung Cancer
• Lung Adenocarcinoma
• EGFR-mutated Lung Cancer
• Early-stage Lung Cancer
• Inoperable Lung Cancer
• Recurrent Lung Cancer
• Pulmonary Nodules
• Thoracic Oncology
• Targeted Cancer Therapy
• Radiation Oncology

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