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Non Small Cell Lung CancerNCT04197076

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

An observational study of Non Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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） Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
anti-PD-1 or anti-PD-L1, EGFR-TKI, ALK inhibitor, ROS1 inhibitor and investigator decided
How many people
200 participants
Where
1 siteChina
Study dates
25 Feb 2019to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Shun D Lu contact

86-21-62821990 ext. 15216769608

shunlu@sjtu.edu.cn

Yaxian Yao contact

15216769608

yaxianyao@hotmail.com

China1 site, 1 recruiting

  • Oncology Department, Shanghai Chest Hospital

    Shanghai

    Yaxian Yao, 15216769608

    Recruiting

Other trials in China

About this study

Official title: An Open, Observational Clinical Study, 2-3 Cycles Treatment as Neoadjuvant Therapy for NSCLC With Stage IIB-IIIB

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）

Read the detailed description

This is an open, observational clinical study, 2-3 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage IIB-IIIB.

Study design:

Newly diagnosed Resectable IIB-IIIB NSCLC EGFR/ALK/ROS1 TEST PD-L1 TEST Collect puncture biopsy tissue/ Blood sample in screening period Chest enhanced CT Conditions allowed， whole body PETCT Exam; Group A：Targeted therapy Tumors with Driver genes （EGFR/ALK/ROS1 Positive） 2 cycles（42 days; Group B：Immunotherapy Enroll Patients from 816 Research treated with Neoadjuvant immunotherapy Or, treated with immunotherapy in practice（with approval） Group C：Routine Chemotherapy Driver genes（EGFR/ALK/ROS1 Negative） and PD-L1 Test negative or unknown; Operation （within 6 Ws postoperation） Standard treatment， Allow adjuvant chemotherapy±radio therapy Collect resected tissue sample(Tumor T and Node N) /Blood sample; comparisons before and after treatment: Imaging：CT、PET-CT Sample：Tumor tissue、blood

Objective and End point:

  1. Main objective and end point：DFS，pCR rate
  2. Second objective and end point：OS
  3. Exploratory objective and end point：cRR rate、relevant AE、Change of Scoring Scale、exploration for relevant biological indicators
Being tested
anti-PD-1 or anti-PD-L1, EGFR-TKI, ALK inhibitor, ROS1 inhibitor, investigator decided
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-PD-1 or anti-PD-L1Drug

    Also called Neoadjuvant immunotherapy

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

  • EGFR-TKI, ALK inhibitor, ROS1 inhibitorDrug

    Also called Neoadjuvant targeted therapy

    targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor

  • investigator decidedDrug

    Also called Neoadjuvant chemotherapy

    chemotherapy

Study groups in NCT04197076
Study groupRoleWhat they receive
Neoadjuvant immunotherapypd-1 or pd-l1 inhabitors
Receives: Drug: anti-PD-1 or anti-PD-L1
Neoadjuvant targeted therapyTKIs
Receives: Drug: EGFR-TKI, ALK inhibitor, ROS1 inhibitor
Neoadjuvant chemotherapychemotherapy
Receives: Drug: investigator decided

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 36 months

  2. pCR: pathologic complete response

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

    Measured: 36 months

Secondary outcomes (1)

  1. OS: Overall survival

    The time length from the date of randomization (according to the received pathology and genetic diagnosis report) to the date of death.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2019
  2. Study start25 Feb 2019
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197076
Sponsor's protocol ID
Neoadjuvant study of NSCLC
Status last verified
Jul 2022
First submitted
27 Apr 2019
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37655106

  • 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.

    PubMed 36059450

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shun D Lu (86-21-62821990 ext. 15216769608, shunlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS: disease free survival (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197076, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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