Clinical trial NCT04685070: Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer
Official title: Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer: A Single-Arm, Open-Label, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage III
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 potential resectable stage III EGFR mutation-positive Non-small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

* NSCLC 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 4 months
Secondary outcomes:
measure: Major pathologic response (MPR)
timeFrame: up to 5 months
measure: Event free survival (EFS)
timeFrame: up to 60 months
measure: Overall survival (OS)
timeFrame: up to 60 months
measure: R0 resection rate
timeFrame: up to 6 months
measure: Treatment-related adverse events
timeFrame: up to 13 months
measure: Pathological complete response rate (pCR)
timeFrame: up to 24 months
Other outcomes:
measure: Potential biomarkers
timeFrame: up to 24 months
measure: Tumor microenvironment dynamics
timeFrame: up to 24 months
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References: