Lung CancerPhase 2GALAXY-02NCT06383728
Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
A Phase 2 study testing Osimertinib in people with Lung Cancer and Carcinoma, Squamous Cell, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Carcinoma, Squamous Cell
- What is being tested?
- Osimertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;
- Gene text confirmed EGFR mutation;
- PET-CT confirmed no metastasis;
- ECOG physical status score 0-1;
- Age ≥ 18 years;
- Have one measurable lesion at least;
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- Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
- Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after treatment, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after treatment;
- Sign informed consent.
Who cannot join
- Patients with other malignant tumors in the five years before the start of this trial.
- Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
- Allergic to experimental drugs;
- Complicated with HIV infection or active hepatitis.
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- Vaccination within 4 weeks before the start of this trial;
- Those who had undergone other major operations or severe injuries within the previous 2 months;
- Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
- Pregnant or lactating women;
- Those with neurological diseases or mental disorders;
- Participated in another therapeutic clinical study at the same time;
- Other researchers did not consider it appropriate to enroll in the group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Shuben Li, Doctor, 13500030280@163.com
About this study
Official title: Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma: A Single-centre, Single-arm, Phase 2 Trial
Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.
Read the detailed description
This trial aims to investigated the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma.
- Conditions
- Lung Cancer, Carcinoma, Squamous Cell
- Being tested
- Osimertinib
- Keywords
- neoadjuvant targeted therapy, EGFR-mutated lung squamous cell carcinoma, surgery
- Medical subject headings
- Lung Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called Tagrisso
Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks). Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate, ORR
Defined as the proportion of participants who had a complete response (CR) or partial response (PR) according to RECIST version 1.1 after treatment.
Measured: analysis is completed 4 weeks after neoadjuvant treatment
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
Measured: from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
Secondary outcomes (6)
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.
Measured: analysis is completed 4 weeks after surgery
R0 rate
There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope.
Measured: analysis is completed 4 weeks after surgery
Progression-free survival (PFS)
PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.
Measured: 2 years
Overall survival (OS)
It is defined as the time from 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. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
Measured: 5 years
Disease control rate (DCR)
The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation
Measured: 2 years
Duration of remission (DOR)
According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1, whichever occurs first.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive osimertinib (80mg/d, ≥9 weeks)
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuben Li, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- shuben Li, Doctor, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383728
- Sponsor's protocol ID
- ES-2024-014-02
- Acronym
- GALAXY-02
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma: A Single-centre, Single-arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT06383728
- Acronym / sponsor ID
- GALAXY-02 / ES-2024-014-02
- Conditions
- Lung Cancer, Carcinoma, Squamous Cell
- Keywords
- neoadjuvant targeted therapy, EGFR-mutated lung squamous cell carcinoma, surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.
Detailed description
This trial aims to investigated the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive osimertinib (80mg/d, ≥9 weeks)
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: OsimertinibPatients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;
- Gene text confirmed EGFR mutation;
- PET-CT confirmed no metastasis;
- ECOG physical status score 0-1;
- Age ≥ 18 years;
Key exclusion criteria (13 listed)
- Patients with other malignant tumors in the five years before the start of this trial.
- Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
- Allergic to experimental drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: TagrissoPatients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks). | Drug | Osimertinib |
Primary outcome
Objective Response Rate, ORR
Time frame: analysis is completed 4 weeks after neoadjuvant treatment
Defined as the proportion of participants who had a complete response (CR) or partial response (PR) according to RECIST version 1.1 after treatment.
Safety: frequency of severe adverse events
Time frame: from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
6 secondary outcomes
Major pathologic response, MPR
Time frame: analysis is completed 4 weeks after surgery
R0 rate
Time frame: analysis is completed 4 weeks after surgery
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 5 years
Disease control rate (DCR)
Time frame: 2 years
Duration of remission (DOR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
shuben Li, Doctor study director
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib in people with Lung Cancer and Carcinoma, Squamous Cell, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuben Li, Doctor (13500030280, 13500030280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, ORR (time frame: analysis is completed 4 weeks after neoadjuvant treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.