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Squamous Cell Lung CancerPhase 2NCT02423590

Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung Cancers

A Phase 2 study testing Apatorsen (OGX-427), Gemcitabine and Carboplatin in people with Squamous Cell Lung Cancer, run by Queen Mary University of London at 20 sites in United Kingdom.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is being carried out to see if a new drug called Apatorsen in combination with standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Lung Cancer
What is being tested?
Apatorsen (OGX-427), Gemcitabine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
20 sitesUnited Kingdom
Study dates
Jun 2014to Jun 2018
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

  • Written informed consent prior to admission to this study
  • Histological or cytological diagnosis of squamous non-small cell lung cancer. Patients with adenosquamous or mixed histology are not eligible for this study.
  • Stage IIIB disease that is unsuitable to radio-chemotherapy or Stage IV disease or recurrent NSCLC; recurrent disease must not be amenable to resection or radical radiotherapy with curative intent.
  • Patients must have:
  • at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) OR
  • lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above
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  • Willing to donate archival diagnostic tissue for translational research, if available.
  • Haematologic and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to randomisation
  • ANC ≥1.5 x 109/L;, platelet count ≥100 x 109/L,
  • Serum creatinine < 1.5 times the upper limit of normal (ULN)
  • Bilirubin level < 1.5 X ULN
  • AST or ALT <3.0 X ULN or <5 X ULN in the presence of liver metastases
  • ECOG performance status 0-2
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant)
  • Male or Female aged ≥18 years

Who cannot join

  • Symptomatic CNS involvement or CNS involvement requiring steroid therapy; patients with treated brain metastases that are asymptomatic and have been clinically stable for 1 month will be eligible for protocol participation
  • Previous systemic treatment for lung cancer (exception for patients who have previously received immunotherapy without chemotherapy, and for patients with recurrent disease: adjuvant chemotherapy is allowed as long as this was finished at least 1 year prior to enrolment and did not contain gemcitabine)
  • Known tumour EGFR mutation, unless contraindication to EGFR-directed therapy
  • Known tumour ALK rearrangements, unless contraindication to Alk-directed therapy or Alk-directed therapy not available 1
  • Pre-existing sensory or motor polyneuropathy >Grade 2 according to NCI CTCAE
  • Significant cardiovascular disease, such as
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  • History of myocardial infarction, acute coronary syndromes (including unstable angina), or history of coronary angioplasty/stenting/bypass grafting within past 6 months.
  • History of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) Classes III-IV.
  • Severe cardiac arrhythmia requiring medication or severe conduction abnormalities
  • Poorly controlled hypertension (resting diastolic blood pressure >115 mmHg)
  • Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy
  • Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
  • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
  • Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United Kingdom20 sites

  • Heart of England NHS Foundation Trust

    Birmingham, B9 5SS

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Colchester Hospital University NHs Foundation Trust

    Colchester, CO3 3NB

  • Betsi Cadwaladr University Health Board

    Denbighshire, LL18 5UJ

  • NHS Tayside

    Dundee, DD2 1UB

  • Medway NHS Foundation Trust

    Gillingham, Kent, ME7 5NY

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford, GU2 7XX

  • NHS Highland

    Inverness, IV2 3UJ

  • Barts Health NHS Trust

    London, EC1M 6BQ

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Lewisham and Greenwich NHS Trust

    London, SE13 6LH

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN

  • Abertawe Bro Morgannwg University Health Board

    Swansea, SA2 8QA

  • Royal Cornwall Hospitals NHS Trust

    Truro, Cornwall, TR1 3LQ

  • Weston Area Health NHS Trust

    Weston-super-Mare, BS23 4TQ

  • Yeovil District Hospital NHS Foundation Trust

    Yeovil, BA21 4AT

Other trials in United Kingdom

About this study

Official title: A Phase II Randomised, Open-label Study of Gemcitabine/Carboplatin First-line Chemotherapy in Combination With or Without the Antisense Oligonucleotide Apatorsen (OGX-427) in Advanced Squamous Cell Lung Cancers

This study is being carried out to see if a new drug called Apatorsen in combination with standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung cancer.

This study is part of a research project for collecting information about the effectiveness and safety of Apatorsen when used with gemcitabine/carboplatin chemotherapy. The main purpose of this study is to see if Apatorsen, when combined with gemcitabine/carboplatin, is an effective treatment for squamous cell lung cancer.

Read more

Recent research has found that a protein called Hsp27 can help cancer cells protect themselves against the effects of cancer treatments. Hsp27 is only found in some lung cancers but when it is present, cancer drugs might not work as well as they would without Hsp27 being present. Blocking the action of Hsp27 or removing Hsp27 from cancer cells with Apatorsen may slow down or stop the cancer growing. This study will therefore look at the relationship between the Hsp27 levels in tumour and blood and the effect of the treatment.

The development of Apatorsen is intended to provide a new treatment option for patients with cancer. Apatorsen may also make the cancer more sensitive to gemcitabine and carboplatin and so make this chemotherapy treatment more effective.

Read the detailed description

This is an open-label, multicentre, 2-arm randomised phase II trial of gemcitabine/carboplatin + Apatorsen (OGX-427) versus gemcitabine/carboplatin alone in patients with previously untreated advanced squamous cell lung cancers. Patients will be randomised (1:1) to one of the two treatment arms:

  • Gemcitabine/carboplatin
  • Gemcitabine/carboplatin + Apatorsen (OGX-427)

Randomisation will be stratified by the following criteria:

  • Stage (IIIB versus IV versus recurrent disease)
  • Performance status (0 or 1 versus 2)

Gemcitabine/carboplatin chemotherapy will be continued for 4-6 cycles unless there is evidence of unacceptable toxicity, disease progression, or if the patient requests that study treatment be discontinued or to be withdrawn from the study. If chemotherapy is discontinued prior to disease progression, patients in the combination arm should be continued on Apatorsen (OGX-427) single agent therapy until disease progression unless there is evidence of unacceptable toxicity, patient withdrawal of consent or termination of the study, whichever occurs first. All patients will be followed for disease progression. Tumour evaluations will be performed before the initiation of treatment and every 6 weeks during and after completion of chemotherapy. Once disease progression is documented, patients will enter a Survival Follow-up Period during which data will be collected every two months regarding further cancer therapy, secondary malignancy and survival status. The study will also assess the relationship between the anticipated anti-tumour activity of the treatment regimen and biological characteristics of patients' tumours at baseline.

Being tested
Apatorsen (OGX-427), Gemcitabine, Carboplatin
Keywords
Squamous, Lung, Apatorsen

What participants receive

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

  • Apatorsen (OGX-427)Drug

    Also called Apatorsen, OGX-427

    Apatorsen (OGX-427) is a second generation antisense oligonucleotide designed to bind to Hsp27 mRNA

  • GemcitabineDrug

    Also called US Brand Name: Gemzar

    Gemcitabine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Gemcitabine is classified as an antimetabolite

  • CarboplatinDrug

    Also called Trade name: Paraplatin ®

    Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."

Study groups in NCT02423590
Study groupRoleWhat they receive
Gemcitabine/CarboplatinActive comparatorGemcitabine/carboplatin will be administered as standard 21-day treatment cycles according to normal clinical practice. * Gemcitabine will be given by 30 minute intravenous infusions on Day 1 and Day 8 of each 21-day Cycle. * On Day 1, carboplatin (AUC5) will be given by infusion over 30-60 minutes.
Receives: Drug: Gemcitabine; Drug: Carboplatin
Gemcitabine/carboplatin + ApatorsenExperimental* Apatorsen (OGX-427) will be administered as an intravenous infusion over 2 hours. * Apatorsen (OGX-427) treatment will begin with a loading dose period prior to the initiation of chemotherapy. Patients will receive three loading doses of 400 mg within a 9-day period with at least 48 hours between infusions and between the last loading dose infusion and Day 1 of initiating chemotherapy. Chemotherapy must be initiated within 7 calendar days once the last loading dose infusion has been completed. * Following the loading dose period, Apatorsen (OGX-427) will be given weekly at a dose of 400 mg by 2 hour intravenous infusions. On days when both chemotherapy and Apatorsen (OGX-427) are given, Apatorsen (OGX-427) should be given first followed by chemotherapy.
Receives: Drug: Apatorsen (OGX-427); Drug: Gemcitabine; Drug: Carboplatin

What is being measured

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

  1. Progression-Free Survival as measured by investigator-assessed (using RECIST 1.1) progression-free survival

    Progression-free survival, defined as the time from the date of randomisation to the date of first documented tumour progression based on investigator assessment (using RECIST 1.1) or death from any cause, whichever occurs first.

    Measured: Date of patient randomisation to the date of first documented tumour progression (estimated 7.5 months) or death

Secondary outcomes (6)

  1. Clinical Activity as measured by response rate (RECIST 1.1), change in tumour size, disease control rate, and duration of response of gemcitabine/carboplatin + Apatorsen relative to gemcitabine/carboplatin alone

    Assess the clinical activity, as measured by response rate (RECIST 1.1), change in tumour size, disease control rate, and duration of response of gemcitabine/carboplatin + Apatorsen (OGX-427) relative to gemcitabine/carboplatin alone

    Measured: At 12 weeks and 24 weeks post-randomisation until disease progression (estimated 7.5 months)

  2. Overall survival benefit of gemcitabine/carboplatin + Apatorsen relative to gemcitabine/carboplatin alone

    Estimate the overall survival benefit of gemcitabine/carboplatin + Apatorsen (OGX-427) relative to gemcitabine/carboplatin alone

    Measured: Date of randomisation to date of death (expected average 12 months)

  3. Clinical benefit as measured by investigator assessment using RECIST 1.1

    Estimate the clinical benefit of gemcitabine/carboplatin + Apatorsen (OGX-427) relative to gemcitabine/carboplatin alone, as measured by investigator-assessed PFS rate at 12 and 24 weeks

    Measured: At 12 and 24 weeks post-randomisation

  4. Drug exposure measured as average dose per week

    Evaluate drug exposure of gemcitabine/carboplatin + Apatorsen (OGX-427). Exposure is defined as average gemcitabine/carboplatin + Apatorsen (OGX-427) dose per week over whole treatment period.

    Gemcitabine/carboplatin chemotherapy will be continued for 6 cycles (each cycle is 21 days) unless there is evidence of unacceptable toxicity, disease progression, or if the patient requests that study treatment be discontinued or to be withdrawn from the study. If chemotherapy is discontinued prior to disease progression, patients in the combination arm should be continued on Apatorsen (OGX-427) single agent therapy until disease progression unless there is evidence of unacceptable toxicity, patient withdrawal of consent or termination of the study, whichever occurs first.

    Measured: 4-6 cycles of treatment (12-18 weeks) and for apatorsen arm until disease progression (estimated 7.5 months)

  5. Compare the differences in health-related Quality of Life (HRQL) and symptoms for patients by treatment assignment as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, and the Euro-QOL 5D (EQ-5D)

    Compare the differences in health-related quality of life (HRQL) and symptoms for patients by treatment assignment

    Measured: Baseline, once every 3 weeks for 18 weeks and 4 weeks after last dose (estimated 8.8 months)

  6. Establish the safety and tolerability of gemcitabine/carboplatin + Apatorsen relative to gemcitabine/carboplatin alone

    Establish the safety and tolerability of gemcitabine/carboplatin + apatorsen (OGX-427) relative to gemcitabine/carboplatin alone.

    This will include:

    • Incidence of serious adverse events
    • Incidence of grade 3 or higher adverse events (CTCAE, version 4.0)
    • Incidence of all adverse events of all grades
    • Incidence of infusion reactions and infusion-related adverse events
    • Adverse events leading to discontinuation of the study medication
    • Incidence of Grade 3 and 4 clinical laboratory results following study drug administration (CTCAE, version 4.0.3)

    Measured: 3 weeks before treatment to 4 weeks after last dose (estimated 8.5 months)

Timeline

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

  1. First posted22 Apr 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2018 (estimated)
  4. Study completionJun 2018 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02423590
Sponsor's protocol ID
009436QM
Status last verified
Aug 2017
First submitted
11 Jul 2014
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatorsen (OGX-427), Gemcitabine and Carboplatin in people with Squamous Cell Lung Cancer, run by Queen Mary University of London at 20 sites in United Kingdom.

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 15 inclusion and 15 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United Kingdom. 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?

Progression-Free Survival as measured by investigator-assessed (using RECIST 1.1) progression-free survival (time frame: Date of patient randomisation to the date of first documented tumour progression (estimated 7.5 months) or death). 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 NCT02423590.

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 Aug 2017.

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