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Non-Small Cell Lung CancerPhase 2NeoIpowerNCT05104788

A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

A Phase 2 study testing Icotinib, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer 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?
Icotinib, Cisplatin and Carboplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
25 Oct 2021to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • Male or female, at least 18 years of age.
  • Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.
  • Clinical stage IIA/IIB/IIIA/IIIB assessed by EBUS-TBNA or PET(positron emission tomography)/CT can be resected.
  • EGFR mutation was detected by Amplification Refractory Mutation System(ARMS) and confirmed to be one of the 2 common EGFR mutations known to be associated with EGFR-TKI （epidermal growth factor receptor tyrosine kinase inhibitors）sensitivity (Ex19del, L858R).
  • Presence of at least one accurately measurable lesion, CT showing a maximum diameter of 10mm at baseline (except for lymph nodes with a short axis of 15mm required) and suitable for accurate repeat measurements.
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  • Eastern Cooperative Oncology Group (ECOG) performance status （PS） of 0 or 1 at enrolment.
  • Hematology , liver and kidney function are adequate for neoadjuvant therapy.
  • Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis).
  • Serum pregnancy test (for females of childbearing potential) negative at screening.Female patients of non-childbearing potential must meet at least 1 of the following criteria:
  • ① Achieved postmenopausal status, defined as follows: cessation of regular menses forat least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle- stimulating hormone (FSH)level confirming the postmenopausal state;
  • ② Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • ③ Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations） are considered to be of childbearing potential.
  • Male subjects must be willing to use barrier contraception

Who cannot join

  • Mixed squamous cell carcinoma, large cell carcinoma，small cell lung cancer.
  • Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
  • Pregnant female patients; breastfeeding female patients.
  • Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of Cytochrome P450 3A4(CYP3A4)(at least 3 weeks prior).
  • Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (e.g., in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Clinically significant cardiovascular disease, that is, active or within 3 months prior to enrollment: cerebral vascular accident/stroke, myocardial infarction, unstable angina,congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree Atrioventricular（AV）block (unless paced) or any AV block with PR >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc(corrected QT interval) >470 msec, or congenital long QT syndrome.
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  • A history of hypersensitivity to Icotinib with or without active excipients or to drugs of similar chemical structure or class, and uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated drugs, or having undergone major bowel resection that would interfere with adequate absorption of Icotinib.
  • Past medical history of Interstitial lung disease（ ILD）, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • Inadequate bone marrow reserve (a leukocyte count less than 4000 mm3, a platelet count less than 100,000 mm3, and a hemoglobin level less than 10 g/dL); adequate renal function deficiency(not normal serum creatinine and blood urea nitrogen levels, and a creatinine clearance level 60 mg/minute); and an inadequate serum aspartate aminotransferase level more than 2.5 times the upper normal limit (UNL) and a serum alanine aminotransferase level more than 2.5 times the UNL.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

NAN Wu, M.D. contact

8613466692698

nanwu@bjmu.edu.cn

China1 site, 1 recruiting

  • BeijingCancerH

    Beijing, 100176

    NAN Wu, nanwu@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Single-Arm, Prospective Study of Neoadjuvant Icotinib With Chemotherapy for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable for Stage II to IIIB(N2) Non-small Cell Lung Cancer

This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

Being tested
Icotinib, Cisplatin, Carboplatin, Pemetrexed
Keywords
Resectable, NSCLC, Icotinib, EGFRm Positive, Neoadjuvant
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.

  • IcotinibDrug

    Oral

  • CisplatinDrug

    Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.

  • CarboplatinDrug

    Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles

  • PemetrexedDrug

    Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 2 cycles

Study groups in NCT05104788
Study groupRoleWhat they receive
Icotinib with platinum-based chemotherapyExperimentalIcotinib 125 mg TID plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Receives: Drug: Icotinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. Major Pathological Response (MPR)

    Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery

    Measured: From date of randomization to an average of 12 weeks after the first dose

Secondary outcomes (7)

  1. Pathological complete response (pCR)

    Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

    Measured: From date of randomization to an average of 12 weeks after the first dose

  2. Overall Survival (OS)

    Defined as the time from the date of entry to the date of death from any cause.

    Measured: Up to approximately 5.5 years after the last patient is randomized

  3. Disease free survival (DFS)

    DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.

    Measured: From date of randomization up to approximately 42 months after date of resection

  4. Objective response rate(ORR)

    ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.

    Measured: Baseline (Prior to surgery)

  5. Disease control rate(DCR)

    DCR is defined as the percentage of participants having a complete response , a partial response and disease stability measured by RECIST 1.1.

    Measured: Baseline (Prior to surgery)

  6. R0 surgical resection rate

    the proportion of resection margin without macroscopic or microscopic tumor residue (negative resection margin)

    Measured: Post surgery (within one week)

  7. Incidence of Adverse Events

    AE captured by CYCAE 5.0

    Measured: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery

Timeline

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

  1. First posted3 Nov 2021
  2. Study start25 Oct 2021 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05104788
Sponsor's protocol ID
BD-IC-IV102
Acronym
NeoIpower
Status last verified
Nov 2021
First submitted
26 Oct 2021
Last updated
3 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Icotinib, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute 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 9 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact NAN Wu, M.D. (8613466692698, nanwu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response (MPR) (time frame: From date of randomization to an average of 12 weeks after the first dose). 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 NCT05104788.

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 3 Nov 2021.

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