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Recruiting Phase 2

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC

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About this study

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

Condition
EGFR, NSCLC (Non-small Cell Lung Cancer), Locally Advanced Non-Small Cell Lung Cancer, Radiotherapy, Chemotherapy
Tested
Fumetinib combined platinum-based double chemotherapy, Concurrent Radiochemotherapy
Sponsor
Peng Zhang

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Study condition: EGFR, NSCLC (Non-small Cell Lung Cancer), Locally Advanced Non-Small Cell Lung Cancer, Radiotherapy, Chemotherapy
  • 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.

Exclusion 10

  • 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.

Where

1 site, 1 recruiting

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.