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

NCT06300424 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: KY2024-162
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; EGFR Gene Mutation

Keywords

non small cell lung cancer; neoadjuvant therapy; immunotherapy; EGFR

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR)

  MPR was defined as percentage of tumor cells within tumor bed less than 10% for primary lung lesions

  MPR will be assessed within 2 weeks after surgery

Secondary Outcomes (2)

• Pathological Complete Response (pCR)

  pCR will be assessed within 2 weeks after surgery

• 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

Other Outcomes (3)

• Overall Survival (OS)

  up to 60 months.

• Event Free Survival (EFS)

  From date of initiation of neoadjuvant treatment till the date of first documented disease progression or death, whichever came first, assessed up to 60 months

• Incidence of Adverse Events (AEs)

  up to 90 days.

Study Arms (1)

Almonertinib and Chemo-immunotherapy

EXPERIMENTAL

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.

Drug: almonertinib; Drug: Carboplatin; Drug: Nab paclitaxel

Interventions

almonertinib DRUG

110mg qd

Almonertinib and Chemo-immunotherapy

Carboplatin DRUG

AUC 5, d1 every 3 weeks

Almonertinib and Chemo-immunotherapy

Nab paclitaxel DRUG

135 mg/m2, d1,d8 every 3 weeks

Almonertinib and Chemo-immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib; Carboplatin; Taxes

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations

Study Officials

• Wen-zhao Zhong, PhD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: January 26, 2026
• Study Completion: April 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)