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

Primary Purpose

Lung Adenocarcinoma Stage III

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HS-10296 (Almonertinib)
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma Stage III

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HS-10296 (Almonertinib)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Disease free survival (DFS)
It refers to the time from radical surgery to relapse or death of a participant due to disease progression
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.
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.
Treatment-related adverse events
It refers to the number of adverse events related to HS-10296 as evaluated according to CTCAE v4.0.

Full Information

First Posted
December 5, 2020
Last Updated
March 17, 2022
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT04685070
Brief Title
Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
Official Title
Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma: A Single-Arm, Open-Label, Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 resectable stage III EGFR mutation-positive lung adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma Stage III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HS-10296 (Almonertinib)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HS-10296 (Almonertinib)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
Major pathologic response (MPR)
Description
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.
Time Frame
up to 5 months
Title
Disease free survival (DFS)
Description
It refers to the time from radical surgery to relapse or death of a participant due to disease progression
Time Frame
up to 60 months
Title
Overall survival (OS)
Description
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.
Time Frame
up to 60 months
Title
Progression-free survival (PFS)
Description
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.
Time Frame
up to 60 months
Title
Treatment-related adverse events
Description
It refers to the number of adverse events related to HS-10296 as evaluated according to CTCAE v4.0.
Time Frame
up to 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhang, MD
Phone
13512185932
Email
zhangpeng1121@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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