Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Stage III Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04685070
• Other study ID #: LungMate-007
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 14, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Non-small Cell Lung Cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage III

Intervention

Drug:
• HS-10296 (Almonertinib)
Neoadjuvant treatment stage: HS-10296 110mg, qd, po, 4 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: HS-10296 110mg, qd, po, up to 48 weeks (including neoadjuvant stage). PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is defined as the proportion of patients who have completed the neoadjuvant treatment before operation and have achieved CR or PR as confirmed by CT evaluation in all patients.	up to 4 months
Secondary	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.	up to 5 months
Secondary	Disease free survival (DFS)	It refers to the time from radical surgery to relapse or death of a participant due to disease progression	up to 60 months
Secondary	Overall survival (OS)	It is defined as the time from random enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.	up to 60 months
Secondary	Progression-free survival (PFS)	It refers to the time from the first administration of HS-10296 in this study to the disease progression or death (including any cause of death in fthe 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	Treatment-related adverse events	It refers to the number of adverse events related to HS-10296 as evaluated according to CTCAE v4.0.	up to 13 months
Secondary	Pathological complete response rate (pCR)	It refers to the number of cases with no residual invasive cancer in the primary tumor and lymph node HE staining accounted for the proportion of all patients who completed the treatment.	up to 24 months