Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Plain-language summary

This study examines pre-surgery (neoadjuvant) almonertinib followed by chemo-immunotherapy (Carboplatin and Nab paclitaxel) in patients with resectable stage II-IIIB EGFR-mutant non-small cell lung cancer. It enrolls patients aged 18 and older whose tumors carry an EGFR mutation (Ex19del, L858R, T790M, G719X, exon 20 insertions, S768I, or L861Q). The study is in Phase 2 and is active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

Guangdong Provincial People's Hospital

Intervention

almonertinib, Carboplatin, Nab paclitaxel

Start date

4/1/2024

Estimated completion

4/30/2026

Countries

China

Related genes

Locations

• Guangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.