Clinical trial · Interventional
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
NCT06300424CI-TRIAL-00109773NEOVADEactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Gene Mutation | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| almonertinib | Drug | Aumolertinib | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Almonertinib and Chemo-immunotherapy
- description
- 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.
- interventionNames
- Drug: almonertinib
- Drug: Carboplatin
- Drug: Nab paclitaxel
Primary outcomes (1)
- measure
- Major Pathological Response (MPR)
- timeFrame
- MPR will be assessed within 2 weeks after surgery
- description
- MPR was defined as percentage of tumor cells within tumor bed less than 10% for primary lung lesions
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.