RECRUITINGPhase 2INTERVENTIONAL
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer, a Single Arm, Phase II Study
About This Trial
Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Male or female，Age: 18 Years and older,
2. Subjects voluntarily joined the study and signed willing to sign a consent form,
3. pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
4. ECOG PS=0 or 1,
5. resectable or potentially resectable, or resectability discussed by MDT,
6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
7. measurable lesion as per RECIST1.1.
Who Should NOT Join This Trial:
1. pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
2. non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
3. with malignant plural effusion,
4. previous treatment to non small cell lung cancer other than this regimen,
5. received thoracic radiotherapy,
6. currently enrolled in other clinical trial,
7. active or known or suspected autoimmune conditions (where your immune system attacks your own body).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Male or female，Age: 18 Years and older,
2. Subjects voluntarily joined the study and signed informed consent,
3. pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
4. ECOG PS=0 or 1,
5. resectable or potentially resectable, or resectability discussed by MDT,
6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
7. measurable lesion as per RECIST1.1.
Exclusion Criteria:
1. pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
2. non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
3. with malignant plural effusion,
4. previous treatment to non small cell lung cancer other than this regimen,
5. received thoracic radiotherapy,
6. currently enrolled in other clinical trial,
7. active or known or suspected autoimmune disease.
Treatments Being Tested
DRUG
almonertinib
110mg qd
DRUG
Carboplatin
AUC 5, d1 every 3 weeks
DRUG
Nab paclitaxel
135 mg/m2, d1,d8 every 3 weeks
Locations (1)
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China