Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
- Conditions
- Non Small Cell Lung CancerEGFR Gene Mutation
- Interventions
- Registration Number
- NCT06300424
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
This study plans to include 32 eligible II-IIIB non small cell lung cancer (NSCLC), patients will receive 6 weeks of almonertinib, and to avoid overlap of interstitial lung disease (ILD) and immune-related pneumonitis, 2 weeks of washout period was designed before 3 cycles of adebrelimab + doublet platinum-based chemotherapy is administered. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients with local disease and resectable or potentially resectable NSCLC will receive anatomic resection. Patients who progress upon neoadjuvant treatment and further assessed as unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will undergo optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) or immunotherapy upon investigators' consideration or CT surveillance. Patients will be follow-up within 5 years after surgery. The primary endpoint of this study is major pathological response (MPR) defined as no more than 10% residual tumor found in primary lung cancer as per International Association for the Study of Lung Cancer (IASLC) criteria.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- Male or female，Age: 18 Years and older,
- Subjects voluntarily joined the study and signed informed consent,
- pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
- ECOG PS=0 or 1,
- resectable or potentially resectable, or resectability discussed by MDT,
- harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
- measurable lesion as per RECIST1.1.
- pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
- non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
- with malignant plural effusion,
- previous treatment to non small cell lung cancer other than this regimen,
- received thoracic radiotherapy,
- currently enrolled in other clinical trial,
- active or known or suspected autoimmune disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Almonertinib and Chemo-immunotherapy Nab paclitaxel 6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity. Almonertinib and Chemo-immunotherapy almonertinib 6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity. Almonertinib and Chemo-immunotherapy Carboplatin 6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Major Pathological Response (MPR) MPR will be assessed within 2 weeks after surgery MPR was defined as percentage of tumor cells within tumor bed less than 10% for primary lung lesions
- Secondary Outcome Measures
Name Time Method Pathological Complete Response (pCR) pCR will be assessed within 2 weeks after surgery The pathological complete response is defined as the absence of residual tumor in both lung and lymph nodes after neoadjuvant treatment.
Objective Response Rate (ORR) Tumor response will be evaluated within 2 weeks after almonertinib, and within 3-4 weeks after last dose of neoadjuvant treatment ORR is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of participants. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Trial Locations
- Locations (1)
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
🇨🇳Guangzhou, Guangdong, China