Clinical Trials in China / NCT06300424
Active, not recruiting
Phase 2
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
NCT06300424 · tracked via the Priya Life Science China tracker
Condition(s) studied
Non Small Cell Lung CancerEGFR Gene Mutation
Investigational drug(s) / intervention(s)
almonertinib: 110mg qd
Carboplatin: AUC 5, d1 every 3 weeks
Nab paclitaxel: 135 mg/m2, d1,d8 every 3 weeks
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences | Guangzhou | Guangdong |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06300424 on ClinicalTrials.gov ↗ ← All trials in China