Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06300424

Recruiting

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

Interventional

Phase 2

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

Sponsor: Guangdong Provincial People's Hospital

Last Updated: April 17, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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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Treatment Category

Chemotherapy, Targeted Therapy

Required Mutations

None

Trial Started

April 3, 2024

Last Updated by Sponsor

April 17, 2024

Estimated Completion

March 1, 2026

Contact Study

Name:Wen-zhao Zhong, PhD

Email:syzhongwenzhao@scut.edu.cn

Phone:+862083827812

Name:Jun-Tao Lin, PhD

Email:237801160@qq.com

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.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll32

Arms & Interventions

Arms

Interventions

Type: Experimental

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.

Interventions:

Carboplatin
Nab paclitaxel
almonertinib

Outcome Measures

Primary Outcome Measures

Major Pathological Response (MPR)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 Outcome Measures

Pathological Complete Response (pCR)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.

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

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.

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Trial Sites

This study has 1 trial site

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

Guangzhou, Guangdong, CN

Name:Wen-zhao Zhong, PhD

Email:syzhongwenzhao@scut.edu.cn

Phone:+86 20 83827812

Recruiting

Guangzhou, Guangdong, 510080 CN

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

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