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AzTrials

Lung AdenocarcinomaNCT05527808

A Single-arm Exploratory Study of Neoadjuvant Therapy

A study testing Tislelizumab, pemetrexed and cis-platemum in people with Lung Adenocarcinoma, run by Jun Liu 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Adenocarcinoma
What is being tested?
Tislelizumab, pemetrexed and cis-platemum
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
1 Aug 2022to 30 Dec 2025
Phase
Interventional
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

Who may be able to join

  • Volunteer to participate in clinical research;Fully understand and be Informed of the study and sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures;
  • Age 18-75 (boundary value included), no gender limitation;
  • Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition);
  • EGFR gene mutation positive (can be tested by tissue or blood samples);
  • PD-L1 ≥ 1%
  • ECOG PS score 0-1 (including boundary value);
Show all 9Show fewer
  • Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
  • Meet the conditions for receiving platinum containing two-drug chemotherapy;
  • The expected survival time is ≥3 months, and feasible surgery is planned;

Who cannot join

  • Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
  • there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).
  • A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Patients with any severe and/or uncontrolled disease or symptom

Trial locations and contacts

1 site in 1 country.

Henry liang, Dr contact

15625064712

hengrui_liang@163.com

China1 site, 1 recruiting

  • First Affiliated Hospital, Guangzhou Medical University

    Guangzhou, Please Select, 510000

    hengrui liang, 15625064712, hengrui_liang@163.com

    jun liu

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Tislelizumab and Platinum-Based Doublet Chemotherapy in Stage II-IIIB EGFR-Mutated Lung Adenocarcinoma With PD-L1 Positive Expression -- A Phase II Study (DuoVitality)"

Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.

Being tested
Tislelizumab, pemetrexed, cis-platemum, or carboplatin
Keywords
Resectable II-IIIB, EGFR mutation and PD-L1≥1%, NSCLC, Neoadjuvant immunotherapy
Medical subject headings
Adenocarcinoma of Lung

What participants receive

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

  • TislelizumabDrug

    200 mg ,intravenous injection ,Q3W 2-4 cycles

  • pemetrexedDrug

    500 mg/m2,intravenous injection ,Q3W 2-4 cycles

  • cis-platemumDrug

    60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles

  • or carboplatinDrug

    AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles

Study groups in NCT05527808
Study groupRoleWhat they receive
Neoadjuvant ICI combined with chemotheroryExperimentalintravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
Receives: Drug: Tislelizumab; Drug: pemetrexed; Drug: cis-platemum; Drug: or carboplatin

What is being measured

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

  1. Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）

    MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

    Measured: 15-18 weeks after enrollment

Secondary outcomes (6)

  1. ORR: Proportion of patients who achieved complete response (CR) or partial response (PR) among all randomized patients with measurable disease at baseline assessed according to RECIST version 1.1

    To evaluate objective response rate (ORR) in neoadjuvant treatment

    Measured: 6-12weeks after enrollment

  2. pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes

    pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

    Measured: 15-18 weeks after enrollment

  3. Descending rate of lymph nodes

    Proportion of patients whose pathologic lymph node stage was reduced to N1/N0 by baseline radiographic assessment of N2 or N1

    Measured: 15-18 weeks after enrollment

  4. Number of Participants with Adverse Events

    To evaluate the safety profile(Number of Participants with Adverse Events)

    Measured: through study completion, an average of 35weeks

  5. The time of surgery delay

    evaluate the interval time from the completation of last neoadjuvant therapy to surgery

    Measured: 4-6weeks after completation of the last neoadjuvant therapy

  6. minimally invasive surgery rate

    explore different surgery manner rate after neoadjuvant

    Measured: 4-6weeks after completation of the last neoadjuvant therapy

Timeline

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

  1. First posted6 Sep 2022
  2. Study start1 Aug 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05527808
Sponsor's protocol ID
Tislelizumab-Neoadjuvant
Status last verified
Jun 2023
First submitted
3 Aug 2022
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chansky K, Detterbeck FC, Nicholson AG, Rusch VW, Vallieres E, Groome P, Kennedy C, Krasnik M, Peake M, Shemanski L, Bolejack V, Crowley JJ, Asamura H, Rami-Porta R; IASLC Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions. The IASLC Lung Cancer Staging Project: External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2017 Jul;12(7):1109-1121. doi: 10.1016/j.jtho.2017.04.011. Epub 2017 Apr 28.

    PubMed 28461257

  • Wozniak AJ, Gadgeel SM. Adjuvant therapy for resected non-small cell lung cancer. Ther Adv Med Oncol. 2009 Sep;1(2):109-18. doi: 10.1177/1758834009338634.

    PubMed 21789116

  • Rosell R, Lopez-Cabrerizo MP, Astudillo J. Preoperative chemotherapy for stage IIIA non-small cell lung cancer. Curr Opin Oncol. 1997 Mar;9(2):149-55. doi: 10.1097/00001622-199703000-00008.

    PubMed 9161793

  • Zhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13.

    PubMed 31194613

  • NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25.

    PubMed 24576776

Questions about this trial

What is this clinical trial studying?

A study testing Tislelizumab, pemetrexed and cis-platemum in people with Lung Adenocarcinoma, run by Jun Liu 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 9 inclusion and 3 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 8 Jun 2023. 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 Henry liang, Dr (15625064712, hengrui_liang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes） (time frame: 15-18 weeks after enrollment). 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 NCT05527808, which also lists 5 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 8 Jun 2023.

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