Neoadjuvant treatment for EGFR-mutant non-small cell lung cancer

Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer, a Single Arm, Phase II Study

This study is testing if a new drug called almonertinib, followed by chemotherapy and immunotherapy, can help people with certain types of lung cancer shrink their tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Drugs / interventions: adebrelimab, almonertinib, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06300424 on ClinicalTrials.gov

What this trial studies

This Phase II, single-arm, open-label study evaluates the safety and feasibility of using almonertinib as a neoadjuvant therapy followed by chemotherapy and immunotherapy in patients with resectable stage IIA-IIIB non-small cell lung cancer (NSCLC) harboring EGFR mutations. Participants will receive 6 weeks of almonertinib, followed by a 2-week washout period, and then 3 cycles of adebrelimab combined with platinum-based chemotherapy. The primary goal is to achieve a major pathological response, defined as having no more than 10% residual tumor in the primary lung cancer. Patients will be monitored for 5 years post-surgery to assess outcomes and any further treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with resectable stage II-IIIB non-small cell lung cancer and specific EGFR mutations.

Not a fit: Patients with small cell lung cancer, other driver gene alterations, or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and overall survival for patients with EGFR-mutant NSCLC.

How similar studies have performed: Other studies have shown promising results with neoadjuvant therapies in NSCLC, but this specific combination approach is novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Wen-zhao Zhong, PhD — Guangdong Provincial People's Hospital
• Study coordinator: Wen-zhao Zhong, PhD

Conditions Non Small Cell Lung Cancer; EGFR Gene Mutation; non small cell lung cancer; neoadjuvant therapy; immunotherapy; EGFR