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NCT Number: NCT06300424

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Gene Mutation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guangzhou, Guangdong, 510080, China

About this study

This study plans to include 32 eligible II-IIIB non small cell lung cancer (NSCLC), patients will receive 6 weeks of almonertinib, and to avoid overlap of interstitial lung disease (ILD) and immune-related pneumonitis, 2 weeks of washout period was designed before 3 cycles of adebrelimab + doublet platinum-based chemotherapy is administered. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients with local disease and resectable or potentially resectable NSCLC will receive anatomic resection. Patients who progress upon neoadjuvant treatment and further assessed as unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will undergo optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) or immunotherapy upon investigators' consideration or CT surveillance. Patients will be follow-up within 5 years after surgery. The primary endpoint of this study is major pathological response (MPR) defined as no more than 10% residual tumor found in primary lung cancer as per International Association for the Study of Lung Cancer (IASLC) criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Almonertinib

Drug

110mg qd

carboplatin

Drug

AUC 5, d1 every 3 weeks

Nab paclitaxel

Drug

135 mg/m2, d1,d8 every 3 weeks

Primary outcomes

  1. Major Pathological Response (MPR)

    Time frame: 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

Secondary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: pCR will be assessed within 2 weeks after surgery

    The pathological complete response is defined as the absence of residual tumor in both lung and lymph nodes after neoadjuvant treatment.

  2. Objective Response Rate (ORR)

    Time frame: Tumor response will be evaluated within 2 weeks after almonertinib, and within 3-4 weeks after last dose of neoadjuvant treatment

    ORR is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of participants. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.

Other outcomes

  1. Overall Survival (OS)

    Time frame: up to 60 months.

    From date of initiation of neoadjuvant treatment till the date of all-cause death, assessed up to 60 months.

  2. Event Free Survival (EFS)

    Time frame: 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

    Time from initiation of neoadjuvant treatment to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause.

  3. Incidence of Adverse Events (AEs)

    Time frame: up to 90 days.

    Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: NEOVADE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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