EGFRPhase 2NCT07742332

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC

A Phase 2 study testing Fumetinib combined platinum-based double chemotherapy and Concurrent Radiochemotherapy in people with EGFR and NSCLC (Non-small Cell Lung Cancer), run by Peng Zhang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: EGFR, NSCLC (Non-small Cell Lung Cancer), Locally Advanced Non-Small Cell Lung Cancer
What is being tested?: Fumetinib combined platinum-based double chemotherapy and Concurrent Radiochemotherapy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteChina
Study dates: 25 Nov 2025to 25 Nov 2032
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peng Zhang contact

02165115006

zhangpeng1121@tongji.edu.cn

Yue Liu contact

02165115006

liuyue199608@163.com

China1 site, 1 recruiting

Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Yue Liu, 02165115006, liuyue199608@163.com
Recruiting

Other trials in China

About this study

Official title: Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC: a Single-center, Randomized Controlled Trial

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

Conditions: EGFR, NSCLC (Non-small Cell Lung Cancer), Locally Advanced Non-Small Cell Lung Cancer, Radiotherapy, Chemotherapy
Being tested: Fumetinib combined platinum-based double chemotherapy, Concurrent Radiochemotherapy
Keywords: Chemotherapy, EGFR, NSCLC (non-small cell lung cancer), radiotherapy, Locally Advanced Non-Small Cell Lung Cancer
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.

Fumetinib combined platinum-based double chemotherapyDrug
Fumetinib combined platinum-based double chemotherapy
Concurrent RadiochemotherapyCombination product
Concurrent Radiochemotherapy

Study groups in NCT07742332
Study group	Role	What they receive
Fumetinib combined platinum-based double chemotherapy	Experimental	Fumetinib combined platinum-based double chemotherapy Receives: Drug: Fumetinib combined platinum-based double chemotherapy
Concurrent Radiochemotherapy	Placebo comparator	Concurrent Radiochemotherapy Receives: Combination Product: Concurrent Radiochemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 60 months

Secondary outcomes (1)

Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 202525 Nov 2032

First posted3 Aug 2026
Study start25 Nov 2025
Primary completion25 Nov 2027 (estimated)
Study completion25 Nov 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EGFRStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07742332
Sponsor's protocol ID: LungMate-030
Status last verified: Jul 2025
First submitted: 29 Jul 2026
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Peng Zhang

02165115006

zhangpeng1121@tongji.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Advanced Non-small Cell Lung Cancer, EGFR Mutation
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Evaluation of the Efficacy and Safety of Befotertinib Combined With Bevacizumab as First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer With Brain Metastases: A Single-Arm, Open-Label, Prospective Phase II Clinical Study
Non-small Cell Lung Cancer (NSCLC), EGFR Mutation-Positive Lung Cancer
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Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study
Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative
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CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease
EGFR Activating Mutation, Leptomeningeal Metastasis
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Firmonertinib Plus Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Cancer: A Phase II Study
Lung Adenocarcinoma, Stage III Lung Cancer

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