Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    56
  • sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
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Updated on 21 April 2022
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Summary

This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as neoadjuvant and adjuvant therapy for resectable stage III EGFR mutation-positive lung adenocarcinoma.

Details
Condition Lung Adenocarcinoma Stage III
Treatment HS-10296 (Almonertinib)
Clinical Study IdentifierNCT04685070
SponsorShanghai Pulmonary Hospital, Shanghai, China
Last Modified on21 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy
At stage III (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
Aged 18-75 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 Criteria

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 suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the trial
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 active hepatitis B, hepatitis C or HIV
The patient suffers from severe or new-onset gastrointestinal diseases with diarrhea as the main symptom
The patient has had or is currently suffering from cardiovascular malformation
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 afatinib or its any excipients
The patient suffers from nervous system diseases or mental diseases and cannot keep compliance with the trial
The patient has any malabsorption condition
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
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