Rezeke Edilebilir ve Potansiyel Olarak Rezeke Edilebilir Evre III-IVA EGFR Mutasyon-Pozitif Akciğer Adenokanserinde Neoadjuvan Furmonertinib ile Bevacizumab veya Tek Başına Furmonertinib

Sade dilde özet

Bu çalışma, EGFR mutasyonu pozitif, evre III-IVA akciğer adenokanserinde (lung adenocarcinoma) ameliyat öncesi (neoadjuvan) verilen Furmonertinib ile Bevacizumab kombinasyonunu ya da tek başına Furmonertinib'i incelemektedir. Çalışmaya, EGFR duyarlı mutasyonu doğrulanmış, ameliyat şansı olan veya olabilecek 18 yaş üzeri hastalar alınmaktadır. Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Müdahale

Furmonertinib, Bevacizumab

Başlangıç

01.02.2022

Tahmini bitiş

31.12.2028

Ülkeler

China

İlgili genler

Merkezler

• Shanghai, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;
* At stage III-IVA (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 feasiblility or potential feasibility to receive radical surgery (radical lung lobectomy+systematic lymph node dissection);
* Good lung function that could tolerate surgical treatment;
* Aged \>= 18 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 cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
* 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 HIV;
* The patient 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 furmonertinib or its any excipients;
* The patient is allergic to bevacizumab or its any excipients;
* 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.