Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC

  • STATUS
    Recruiting
  • End date
    Jun 10, 2023
  • participants needed
    9
  • sponsor
    Juan LI, MD
Updated on 26 December 2021

Summary

Introduction: Although PACIFIC regimen definitive concurrent chemoradiotherapy (CRT) followed by Durvalumab consolidation therapy is considered the standard of care for most of stage III NSCLC patients, neoadjuvant immunotherapy combined with chemotherapy followed by surgery has shown the trend to be considered for some potentially resectable patients. The rationales for neoadjuvant treatment are tumor regression effect before surgery, early eradication of micrometastasis. Recently the investigators also find some clinical trials exploring the adding of 45 Gy in 25 fractions radiation to the combination of chemotherapy and immunotherapy neoadjuvant therapy and the investigators could see the safety is the most concern, especially the pneumonitis incidence. Low dose radiation could help control the toxicity induced by radiation and has synergic effect with immunotherapy. The aim of this phase Ib study is to assess the safety and feasibility of the combination of the concurrent low dose radiation, chemotherapy and Durvalumab neoadjuvant therapy, to explore which radiation dose is the best among our three-dose designs and evaluate if the combining neoadjuvant therapy could further improve MPR in the meantime no severe toxicities especially the grade 3-4 pneumonitis would happen.

Method: 9 eligible patients with histologically confirmed NSCLC (potentially resectable clinical stage III according to the American Joint Committee on Cancer 8th staging system) are enrolled. Patients receive Chemo (Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mg/m2 and carboplatin AUC 5 ) and durvalumab (Day 1 and 22, 1500mg) and radiotherapy of 10 Gy in 5 fractions, 20 Gy in 10 fractions, 30 Gy in 15 fractions respectively in our three groups from Day1, followed by surgery. After surgery, patients are suggested to be treated with durvalumab for one year (every 4weeks, 1500 mg). The primary endpoints are safety and tolerability. The secondary endpoints are objective response rate (ORR), event-free survival EFS), overall survival (OS), pathologic complete response (pCR), and major pathologic response(MPR) in the primary tumor. biomarker analysis of PD-L1 using cancer tissue and LIPI, ctDNA using blood sample will be conducted pre-and post- neoadjuvant and post-surgery.

Details
Condition Stage III Non-small Cell Lung Cancer
Treatment durvalumab, Low Dose Radiation Therapy, nanoparticle albumin bound paclitaxel
Clinical Study IdentifierNCT05157542
SponsorJuan LI, MD
Last Modified on26 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 ≥ years
Histological or cytological diagnosis of NSCLC by needle biopsy, and potentially resectable stage III confirmed by image logical examinations (CT, PET-CT or EBUS)
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1
Life expectancy is at least 12 weeks
At least 1 measurable lesion according to RECIST 1.1
With the feasibility or anticipated feasibility after neoadjuvant therapy to receive radical surgery
Patients with good function of other main organs (liver, kidney, blood system, etc.)
ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L,hemoglobin ≥90 g/L; 2) the international standard ratio of prothrombin time (INR) and prothrombin time (PT) < 1.5 times of upper limit of normal (ULN); 3) Partial thromboplastin time (APTT) ≤1.5×ULN; 4) Total bilirubin ≤1.5×ULN; 5) Alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor
Patients with normal lung function can tolerate surgery; 9. Without systematic metastasis (including M1a, M1b and M1c); 10. The patient shall sign the Informed Consent Form

Exclusion Criteria

Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment
Administration of any Chinese medicine against cancer before administration of the drug
Participants with other cancer within five years before the start of this study
Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases
With activate or suspectable autoimmune disease, or autoimmune para cancer syndrome requiring systemic treatment
Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial
Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted
Participants who are allergic to the test drug or any auxiliary materials
Participants with active hepatitis B, hepatitis C or HIV
The vaccine was administered within 4 weeks of the start of the trial
Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial
Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion
The patients have active pia meningioma, uncontrolled or untreated brain metastases
Pregnant or lactating women
Participants suffering from nervous system diseases or mental diseases that cannot cooperate
Participated in another therapeutic clinical study
Other factors that researchers think it is not suitable for enrollment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note