Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC

NCT07742332 | Recruiting Phase 2 DMC

• 1 other identifier: LungMate-030
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.

Conditions

EGFR; Radiotherapy; Chemotherapy; NSCLC (Non-small Cell Lung Cancer); Locally Advanced Non-Small Cell Lung Cancer

Keywords

Chemotherapy; EGFR; NSCLC (non-small cell lung cancer); radiotherapy; Locally Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

  up to 60 months

Secondary Outcomes (1)

• Major pathologic response (MPR)

  up to 4 months

Other Outcomes (5)

• Objective response rate (ORR)

  Up to 4 months

• Event-free survival (EFS)

  Up to 60 months

• Disease-free survival (DFS)

  up to 60 months

Study Arms (2)

Fumetinib combined platinum-based double chemotherapy

EXPERIMENTAL

Fumetinib combined platinum-based double chemotherapy

Drug: Fumetinib combined platinum-based double chemotherapy

Concurrent Radiochemotherapy

PLACEBO COMPARATOR

Concurrent Radiochemotherapy

Combination Product: Concurrent Radiochemotherapy

Interventions

Fumetinib combined platinum-based double chemotherapy DRUG

Fumetinib combined platinum-based double chemotherapy

Fumetinib combined platinum-based double chemotherapy

Concurrent Radiochemotherapy COMBINATION_PRODUCT

Concurrent Radiochemotherapy

Concurrent Radiochemotherapy

Eligibility Criteria

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

You may qualify if:

• NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
• At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
• No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
• With the feasibility to receive radical surgery ;
• Good lung function that could tolerate surgical treatment;
• Minimum age: 18 years;
• At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm);
• Other major organs shall function well (liver, kidney, blood system, etc.):
• ECOG PS score shall be 0-1;
• The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
• The patient shall sign the Informed Consent Form.

You may not qualify if:

• The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
• The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
• The patient is a carrier of HIV;
• The patient has had or is currently suffering from interstitial lung disease;
• The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
• The patient is allergic to befotertinib or its any excipients;
• The patient is allergic to bevacizumab or its any excipients;
• The patient is allergic to platinum-based double chemotherapy or its any excipients;
• The female patient is in pregnancy or lactation period;
• There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Sponsors & Collaborators

• Peng Zhang: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Peng Zhang

CONTACT

02165115006; zhangpeng1121@tongji.edu.cn

Yue Liu

CONTACT

02165115006; liuyue199608@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Archiater

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: November 25, 2025
• Primary Completion (Estimated): November 25, 2027
• Study Completion (Estimated): November 25, 2032
• Last Updated: August 3, 2026

Record last verified: 2025-07

Locations

CN (1)