Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer Stages IIB-IIIB

NCT04197076 | Unknown

• 1 other identifier: Neoadjuvant study of NSCLC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy and safety of targeted therapy and chemotherapy±immunotherapy as neoadjuvant therapy in stage IIB-IIIB NSCLC patients.（observational study）

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• DFS: disease free survival

  The time length from randomization(mainly from the receipt of pathology and genetic diagnosis reports)to any of the following events: disease progression, disease recurrence or death from any cause. Disease progression or relapse will be assessed according to RECIST 1.1

  36 months

• pCR: pathologic complete response

  the proportion of patients achieved pathologic complete response（lung and lymph node without tumor residual assessed by pathology review)

  36 months

Secondary Outcomes (1)

• OS: Overall survival

  36 months

Other Outcomes (3)

• cRR rates

  approximately 10 weeks After surgery

• Safty AEs

  36 months

• Qol Quality of Life

  36 months

Study Arms (3)

Neoadjuvant immunotherapy

pd-1 or pd-l1 inhabitors

Drug: anti-PD-1 or anti-PD-L1

Neoadjuvant targeted therapy

TKIs

Drug: EGFR-TKI, ALK inhibitor, ROS1 inhibitor

Neoadjuvant chemotherapy

chemotherapy

Drug: investigator decided

Interventions

anti-PD-1 or anti-PD-L1 DRUG

immunotherapy anti-PD-1 or anti-PD-L1

Also known as: Neoadjuvant immunotherapy

Neoadjuvant immunotherapy

EGFR-TKI, ALK inhibitor, ROS1 inhibitor DRUG

targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor

Also known as: Neoadjuvant targeted therapy

Neoadjuvant targeted therapy

investigator decided DRUG

chemotherapy

Also known as: Neoadjuvant chemotherapy

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NSCLC participants in stage IIB-IIIB(American Joint Committee on Cancer 8th edition criteria)

You may qualify if:

• Primary non-small cell lung cancer confirmed by cytology or histology
• According to the TNM stage (8th Edition) of IASLC lung cancer, it is determined to be IIB-IIIB stage non-small cell lung cancer, which is considered to be resectable;
• There must be at least one evaluable focus judged according to recist1.1 standard (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on general CT is at least 20 mm)
• ECOG PS 0 or 1
• There are tumor samples available for gene detection (EGFR / ALK / ros1) and PD-L1 immunohistochemistry (IHC) in the subjects, and the tumor samples should be obtained within 3 months before enrollment.
• If all suspected mediastinal lymph nodes (including those with pathological enlargement or FDG concentration on PET / CT) can be examined by EBUS, thoracoscopy or mediastinoscopy, further sampling is required for pathological confirmation.
• Male or female, ≥ 18 years old
• Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl
• Adequate liver function: total bilirubin ≤ upper limit of normal value (ULN); AST and alt ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)
• Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN) or calculated creatinine clearance ≥ 60ml / min
• No anti-tumor drug treatment in the past
• For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of study treatment, and the patients have recovered
• Women with a full uterus must have negative pregnancy test results within 28 days before entering the study (unless it is 24 months after amenorrhea). If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for verification (within 7 days before the first administration)
• Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)

You may not qualify if:

• Have other malignant tumors in the last 5 years
• AST and / or ALT \> 2.5 times of the upper limit of normal value (ULN), with alkaline phosphatase \> 5 times of the upper limit of normal value (ULN)
• Previously received radiotherapy
• Previously used chemotherapy drugs, targeted and immunotherapy drugs (except bisphosphonates)
• There are any uncontrolled systemic diseases, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, myocardial infarction (within 1 year before treatment), serious arrhythmia requiring drug treatment, liver, kidney and metabolic diseases
• Women in pregnancy or lactation
• The patient (male or female) has the possibility of childbearing but is unwilling or does not take effective contraceptive measures
• Receive the experimental treatment of other clinical studies at the same time (in the treatment period of clinical studies)
• Known to be allergic to possible chemotherapy drugs
• There is evidence of other diseases, neurological or metabolic dysfunction, abnormal physical examination or laboratory examination, and it is suspected that there may be a high risk of contraindications to the study drug or complications related to treatment

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Oncology Department, Shanghai Chest Hospital

Shanghai, China

RECRUITING

Related Publications (2)

• Qi Y, Gu L, Shen J, Yao Y, Zhao Y, Lu S, Chen Z. An open, observational clinical study of neoadjuvant therapy in resectable stage III non-small cell lung cancer. Front Oncol. 2023 Aug 16;13:1194100. doi: 10.3389/fonc.2023.1194100. eCollection 2023.

  PMID: 37655106 DERIVED

• Gu L, Wang X, Sun Y, Xu Y, Niu X, Zhao R, Yao Y, Jian H, Han Y, Wei J, Chen Z, Lu S. An open, observational, three-arm clinical study of 2-3 cycles of treatment as neoadjuvant therapy in operable locally advanced non-small cell lung cancer: An interim analysis. Front Immunol. 2022 Aug 19;13:938269. doi: 10.3389/fimmu.2022.938269. eCollection 2022.

  PMID: 36059450 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Subject's tumor sample obtained within 3 months before enrollment is suitable to be used for gene testing（EGFR/ALK/ROS1）and PD-L1 testing with Immunohistochemistry (IHC)。

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Neoadjuvant Therapy

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)

Combined Modality Therapy; Therapeutics

Study Officials

• Shun Lu

  Shanghai Chest Hospital

  STUDY CHAIR

Central Study Contacts

Shun D Lu

CONTACT

86-21-62821990; shunlu@sjtu.edu.cn

Yaxian Yao

CONTACT

15216769608; yaxianyao@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncology

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: December 12, 2019
• Study Start: February 25, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)