AzTrials
AzTrials

Non Small Cell Lung CancerPhase 2NCT02771314

Liquid Biopsy as a Tool to Evaluate Resistance to First and Third (AZD9291) (EGFR) (TKIs) in (EGFR) Mutant NSCLC

A Phase 2 study testing AZD9291 in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 13 sites in Greece.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Based on the possibilities that both plasma and circulating tumor cells (CTCs) (the "liquid biopsy") may offer, we consider that it could be feasible to longitudinally monitor the genetic evolution and the biologic characteristics of CTCs, by using Circulating tumor DNA (ctDNA) and CTCs as a source of biologic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
AZD9291
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
13 sitesGreece
Study dates
2 Aug 2016to Dec 2020
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years
  • Both sexes
  • Histologically or cytologically documented NSCLC
  • Stage 3b (IIIb) not amenable to radical therapy or stage IV
  • Presence of EGFR activating mutations (exon 19 deletion or L858R in exon 21)
  • First or second line treatment with EGFR TKIs
Show all 14Show fewer
  • Performance status (ECOG): 0-1
  • Measurable or evaluable disease
  • Adequate organ function tests (Hb>=10g/dL, white blood cell (WBC) >=3.0 x 10^9/L, neutrophils count >=1.5 x 10^9/L, platelets≥100 x 10^9/L, Creatinine clearance >=50 mL/min, Total bilirubin=<1.5 X UNL, aspartate aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphatase (ALP) =<2.5 x UNL)
  • Normal QT interval in ECG
  • Central nervous system (CNS) metastases are allowed provided that they have been irradiated and the patient is clinically stable
  • Women of child bearing potential and all men will be required to use adequate contraceptive measures
  • Life expectancy of at least 3 months
  • Written informed consent

Who cannot join

  • History of serious drug allergy
  • Refractory nausea, vomiting and chronic gastrointestinal diseases
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
Show all 10Show fewer
  • Severe or uncontrolled systemic liver disease, including those with known hepatitis B, hepatitis C, and Human Immunodeficiency virus (HIV) infection
  • Interstitial lung disease or pulmonary fibrosis
  • Pregnancy, lactation or other concomitant serious medical condition
  • Other concurrent active malignancy

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Greece13 sites

  • 251 Air Forces Military Hospital of Athens

    Athens

  • Anticancer Hospital of Athens "Agios Savvas"

    Athens

  • Athens Hospital "Mitera" Hygia Polis

    Athens

  • General Hospital of Athens "Aretaieio"

    Athens

  • General Hospital of Athens "Evangelismos"

    Athens

  • General Oncology Hospital of Athens "Ag. Anargiroi"

    Athens

  • IASO General Hospital

    Athens

  • Universtiy Hospital of Athens "Attikon"

    Athens

  • University Hospital of Heraklion Crete

    Heraklion, Crete, 71110

  • University Hospital of Patra-Rio

    Rio, 26504

  • Diabalkaniko General Hospital of Thessaloniki

    Thessaloniki

  • General Hospital of Thesaloniki "G. Papanikolaou"

    Thessaloniki

  • Thessaloniki Bioclinic

    Thessaloniki

Other trials in Greece

About this study

Official title: A Longitudinal Study Evaluating Molecular Changes Associated With Resistance to First and Third (AZD9291) Generation EGFR TKIs in Patients With EGFR Mutant NSCLC Using "Liquid Biopsy"

Based on the possibilities that both plasma and circulating tumor cells (CTCs) (the "liquid biopsy") may offer, we consider that it could be feasible to longitudinally monitor the genetic evolution and the biologic characteristics of CTCs, by using Circulating tumor DNA (ctDNA) and CTCs as a source of biologic material. This approach could provide information regarding the genetic/molecular changes associated with primary and acquired resistance to AZD9291 and, thus, to facilitate to more appropriately adapt the tailored treatment in this particular group of NSCLC patients. It has been recently reported that the detection of resistant clones, based on the tumor-associated genetic aberrations in the blood, can identify treatment resistance up to 10 months earlier than the radiological methods providing, thus, the potential for an early switch to a non cross-resistant therapy in order to improve patients' outcome.

Read the detailed description

Lung cancer is among the most common tumor types representing 13% of the newly diagnosed cancers worldwide. Both the absolute and relative frequency of lung cancer has risen dramatically. Unfortunately, lung cancer remains by far the leading cause of cancer-related deaths, accounting for 18% of the total number of deaths. Non Small Lung Cancer (NSCLC) accounts for 85% of all cases of lung cancer and is further classified in several subtypes based on various molecular and histological features.

The initial dose of 80 mg AZD9291 administered once daily orally in the fasted state can be reduced to 40 mg AZD9291 once daily under circumstances

Single arm, open-label, phase II, multicenter study. NSCLC patients with activating EGFR mutations, who are under front line treatment with first generation EGFR TKIs according to the physicians' choice and present disease progression, will be treated with single agent AZD9291. The patients will be followed every 3 months for the detection of mutations (T790M), (C797S), (L858R), del 19 EGFR mutations as well as the mutations [(KRAS)/(NRAS), (BRAF), (PI3K)] in the serum/plasma, the determination of the serum levels of Hepatocyte Growth Factor (HGF), the presence of T790M (+) and C797S(+) CTCs as well as the molecular (c-MET) and (HER2 amplification) and phenotypic characterization of CTCs using the filtration platform (ISET). The elimination or the emergence of each of these circulating tumor biomarkers will be correlated with patients' clinical outcome [objective response to treatment (ORR), (PFS) and (OS)].

There is no specific control group in this study. Biomarkers profile at baseline will be used as internal control for each patient to monitor changes throughout treatment.

Being tested
AZD9291
Keywords
NSCLC, AZD9291, >= 2nd line, liquid biopsy, EGFR TKIs, EGFR mutant
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.

  • AZD9291Drug

    Also called Tagrisso, Osimertinib

    AZD9291, 80 mg (tablets) once daily, administered orally in the fasted state

Study groups in NCT02771314
Study groupRoleWhat they receive
AZD9291ExperimentalAZD9291
Receives: Drug: AZD9291

What is being measured

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

  1. Biomarkers of resistance to first and third (AZD9291) generation EGFR TKIs, explored by studying baseline serial serum or plasma DNA specimens and baseline Circulating Tumor Cells (CTCs)

    Measured: Up to 2.5 years

Secondary outcomes (3)

  1. Progression free survival (PFS)

    Measured: Up to 2.5 years

  2. Overall Survival

    Measured: Up to 2.5 years

  3. Response rate, assessed using RECIST 1.1

    Measured: Up to 2.5 years

Timeline

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

  1. First posted13 May 2016 (estimated)
  2. Study start2 Aug 2016
  3. Primary completionJun 2020 (estimated)
  4. Study completionDec 2020 (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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771314
Sponsor's protocol ID
D5160C00030
Status last verified
Feb 2019
First submitted
12 Apr 2016
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Ntzifa A, Themistokli E, Strati A, Zavridou M, Tsaroucha E, Sfika A, Psyrri A, Balgouranidou I, Kotsakis A, Georgoulias V, Lianidou E. AXL-mRNA Overexpression in Size-Based Enriched Circulating Tumor Cells as a Potential Biomarker for Anti-AXL Targeted Therapies in Non-Small-Cell Lung Cancer. Cancers (Basel). 2026 May 28;18(11):1759. doi: 10.3390/cancers18111759.

    PubMed 42279342

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD9291 in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 13 sites in Greece.

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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Greece. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarkers of resistance to first and third (AZD9291) generation EGFR TKIs, explored by studying baseline serial serum or plasma DNA specimens and baseline Circulating Tumor Cells (CTCs) (time frame: Up to 2.5 years). 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 NCT02771314, which also lists 1 linked publication.

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 22 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in