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Stage III Non-small Cell Lung CancerPhase 1NCT05157542

Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC

A Phase 1 study testing Durvalumab, nanoparticle albumin bound paclitaxel and low dose radiation therapy in people with Stage III Non-small Cell Lung Cancer, run by Juan LI, MD 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stage III Non-small Cell Lung Cancer
What is being tested?
Durvalumab, nanoparticle albumin bound paclitaxel and low dose radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
10 Jun 2021to 10 Jun 2023
Phase
Phase 1
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

  • 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;
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  • Patients with good function of other main organs (liver, kidney, blood system, etc.):
  • 1) 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.
  • 8. 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Juan Li, Doctor, +86 13880276636, dr.lijuan@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib Trial on the Safety and Feasibility of Neoadjuvant Low Dose Radiation, Chemotherapy and Durvalumab for Potentially Resectable Stage III Non-small Cell Lung Cancer (NSCLC)

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.

Being tested
Durvalumab, nanoparticle albumin bound paclitaxel, low dose radiation therapy
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.

  • DurvalumabDrug

    Day 1 and 22, 1500mg

  • nanoparticle albumin bound paclitaxelDrug

    Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mg/m2 and carboplatin AUC 5

  • low dose radiation therapyRadiation

    10 Gy in 5 fractions, 20 Gy in 10 fractions, 30 Gy in 15 fractions respectively in our three groups from Day1

Study groups in NCT05157542
Study groupRoleWhat they receive
ArmExperimentalDurvalumab 1500mg, IV, Q3W, 2 cycles Albumin paclitaxel 260 mg/m2 + Carboplatin AUC5, IV, Q3W, 2 cycles Chemoradiotherapy(CRT): Cohort 1: 2 Gy in 5 Fraction Cohort 2: 2 Gy in 10 Fraction Cohort 3: 2 Gy in 15 Fraction
Receives: Drug: Durvalumab; Drug: nanoparticle albumin bound paclitaxel; Radiation: low dose radiation therapy

What is being measured

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

  1. Incidence of treatment-emergent adverse events

    Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit. AEs and SAEs will be examined with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.

    Measured: 30 days after last dose up to 36 months

Secondary outcomes (4)

  1. ORR

    Objective Response Rate determined by Response Evaluation Criteria in Solid Tumors

    Measured: 36 months

  2. EFS

    Event-free survival

    Measured: 36 months

  3. MPR

    Major pathological response rate

    Measured: 36 months

  4. pCR

    Pathological complete response rate

    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 posted15 Dec 2021
  2. Study start10 Jun 2021
  3. Primary completion10 Jun 2023 (estimated)
  4. Study completion10 Jun 2023 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157542
Sponsor's protocol ID
EK2021001
Status last verified
Dec 2021
First submitted
24 May 2021
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Durvalumab, nanoparticle albumin bound paclitaxel and low dose radiation therapy in people with Stage III Non-small Cell Lung Cancer, run by Juan LI, MD 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 17 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 15 Dec 2021. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: 30 days after last dose up to 36 months). 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 NCT05157542.

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 15 Dec 2021.

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