Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

NCT06383728 | Recruiting Phase 2

• 1 other identifier: ES-2024-014-02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer; Carcinoma, Squamous Cell

Keywords

neoadjuvant targeted therapy; EGFR-mutated lung squamous cell carcinoma; surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.

Secondary Outcomes (6)

• Major pathologic response, MPR

  analysis is completed 4 weeks after surgery

• R0 rate

  analysis is completed 4 weeks after surgery

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  5 years

• Disease control rate (DCR)

  2 years

Study Arms (1)

Osimertinib

EXPERIMENTAL

Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks).

Drug: Osimertinib

Interventions

Osimertinib DRUG

Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks).

Also known as: Tagrisso

Osimertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Squamous Cell

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• shuben Li, Doctor

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Shuben Li, Doctor

CONTACT

13500030280; 13500030280@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Administrative Director of thoracic surgery

Model Details: Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive osimertinib (80mg/d, ≥9 weeks)

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)