Small Cell Lung CancerPhase 2NCT02722369
STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
A Phase 2 study testing Gemcitabine, Carboplatin and Etoposide in people with Small Cell Lung Cancer, run by University College, London at 13 sites in United Kingdom.
Trial summary
To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Gemcitabine, Carboplatin and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 14 Mar 2017to 12 Mar 2021
- 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
- Histologically or cytologically confirmed SCLC
- Stage IV disease
- Performance status ECOG 0-2
- Life expectancy >8 weeks
- Age 18 or over
- Willing and able to give informed consent
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- Patient considered able to tolerate chemotherapy
- Adequate renal function - defined by GFR ≥50mL/min as measured by EDTA or C\&G
- Adequate bone marrow reserve: Absolute neutrophil count ≥1.5 x 109/L, haemoglobin ≥90 g/L, platelet count ≥100 x 109/L
- Negative pregnancy test for WCBP
- Highly effective contraception is mandatory for all patients of reproductive potential
- At least one site of measurable disease (target lesion) for RECIST 1.1 evaluation
- Hypersensitivity or history of severe allergic reaction to any of the IMPs
- Able to swallow medication
Who cannot join
- Mixed cell histology (i.e. NSCLC and SCLC)
- Prior macular degeneration or diabetic retinopathy
- History of glaucoma
- Patients with abnormal LFTs (ALP, ALT/AST*) that are ≥3 x ULN (≥5 x ULN for patients with liver metastases)
- Patients with abnormal bilirubin levels that are ≥1.5 x ULN
- Prior treatment for this disease e.g. chemotherapy, surgery, radiotherapy (except palliative radiotherapy to bone metastases)
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- Documented side effects to chloroquine or related agents
- Treatment with chloroquine or related agents within the last year prior to randomisation
- Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
- Previous medical history of prolonged QT interval
- A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
- Patients with symptomatic brain metastases
- Women who are breastfeeding
- Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs e.g. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine
- Patients who are unable to have their digoxin levels regularly monitored
- if both ALT and AST performed then both need to be recorded
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Dorset County Hospital NHS Foundation Trust
Dorchester
Royal Surrey County Hospital
Guildford
The Princess Alexandra Hospital NHS Trust
Harlow
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster
University Hospital Leicester NHS Trust
Leicester
Guy's and St Thomas' Hospitals NHS Foundation Trust
London
UCLH
London
The Christie
Manchester
East and North Herts NHS Foundation Trust
Northwood
Nottingham University Hospitals NHS Trust
Nottingham
North West Anglia NHS Trust
Peterborough
Betsi Cadwaladr University Health Board
Rhyl
Airedale NHS Foundation Trust
Steeton
About this study
Official title: A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC)
Read the detailed description
This is a multicentre, randomised, phase II trial which aims to compare the combination of hydroxychloroquine and gemcitabine/carboplatin versus standard carboplatin/etoposide chemotherapy, as first line treat in patients with stage IV disease.
The standard first line chemotherapy treatment remains a platinum-based chemotherapy and this has been unchanged for 20 years. Novel active treatment approaches are urgently needed to improve survival in SCLC.
Patients are randomised to one of two treatment arms; carboplatin/etoposide or gemcitabine/carboplatin/hydroxychloroquine.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Gemcitabine, Carboplatin, Etoposide, Hydroxychloroquine
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Chemotherapy
CarboplatinDrug
Chemotherapy
EtoposideDrug
Chemotherapy
Maintenance Agent
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | * IV carboplatin AUC5 (area under curve) on Day1
* IV etoposide 120mg/m2 Day 1, followed by oral etoposide 100mg BD (twice daily) on Day 2 and Day 3 Receives: Drug: Carboplatin; Drug: Etoposide |
| Investigational Arm | Experimental | * IV gemcitabine 1200mg/m2 on Day 1 and Day 8
* IV carboplatin AUC5 on Day 1
* Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months) Receives: Drug: Gemcitabine; Drug: Carboplatin; Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months
Secondary outcomes (8)
Overall survival
Measured: From date of randomisation to death due to any cause, assessed up to 41 months
Objective response as measured by Response Evaluation Criteria in Solid Tumours (RECIST) v.1.1
Complete Response (CR)/ Partial Response (PR)/ Progressive Disease (PD)/ Stable Disease (SD)
Measured: From first tumour assessment to progression/trial end (whichever is first), assessed up to 41 months
Adverse events
Including ophthalmologic and treatment specific toxicities
Measured: From date of consent to 30 days after final trial treatment
Quality of life as measured by EQ-5D
The questionnaire is a standardised questionnaire
Measured: From baseline to progression/trial end (whichever is first), assessed up to 41 months
Quality of life as measured by QLQC-30
The questionnaire is a standardised questionnaire
Measured: From baseline to progression/trial end (whichever is first), assessed up to 41 months
Quality of life as measured by QLQ-LC-13
The questionnaire is a standardised questionnaire
Measured: From baseline to progression/trial end (whicenver is first), assessed up to 41 months
Compliance measured by dose intensity
Capturing dose delays, modifications and omissions
Measured: From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months
Compliance measured by dose exposure
Capturing dose delays, modifications and omissions
Measured: From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start14 Mar 2017
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Why it stopped: Low recruitment, lack of efficacy and increased adverse events in investigational arm.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722369
- Sponsor's protocol ID
- UCL/12/0515
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On receipt of a request the recipient will consider the proposal, ensure relevant Chief Investigator/Trial Management Group are consulted and, if necessary, Trial Steering Committee and/or Cancer Trials Centre (CTC) Senior Management Group. Any shared data will be in an anonymised format
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT02722369
- Acronym / sponsor ID
- UCL/12/0515
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment, lack of efficacy and increased adverse events in investigational arm.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC)
Detailed description
This is a multicentre, randomised, phase II trial which aims to compare the combination of hydroxychloroquine and gemcitabine/carboplatin versus standard carboplatin/etoposide chemotherapy, as first line treat in patients with stage IV disease.
The standard first line chemotherapy treatment remains a platinum-based chemotherapy and this has been unchanged for 20 years. Novel active treatment approaches are urgently needed to improve survival in SCLC.
Patients are randomised to one of two treatment arms; carboplatin/etoposide or gemcitabine/carboplatin/hydroxychloroquine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Carboplatin, Drug: Etoposide* IV carboplatin AUC5 (area under curve) on Day1 * IV etoposide 120mg/m2 Day 1, followed by oral etoposide 100mg BD (twice daily) on Day 2 and Day 3 |
| Investigational Arm | Experimental | Drug: Gemcitabine, Drug: Carboplatin, Drug: Hydroxychloroquine* IV gemcitabine 1200mg/m2 on Day 1 and Day 8 * IV carboplatin AUC5 on Day 1 * Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed SCLC
- Stage IV disease
- Performance status ECOG 0-2
- Life expectancy >8 weeks
- Age 18 or over
Key exclusion criteria (16 listed)
- Mixed cell histology (i.e. NSCLC and SCLC)
- Prior macular degeneration or diabetic retinopathy
- History of glaucoma
- Patients with abnormal LFTs (ALP, ALT/AST*) that are ≥3 x ULN (≥5 x ULN for patients with liver metastases)
- Patients with abnormal bilirubin levels that are ≥1.5 x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineChemotherapy | Drug | Investigational Arm |
| CarboplatinChemotherapy | Drug | Control Arm, Investigational Arm |
| EtoposideChemotherapy | Drug | Control Arm |
| HydroxychloroquineMaintenance Agent | Drug | Investigational Arm |
Primary outcome
Progression free survival
Time frame: Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months
8 secondary outcomes
Overall survival
Time frame: From date of randomisation to death due to any cause, assessed up to 41 months
Objective response as measured by Response Evaluation Criteria in Solid Tumours (RECIST) v.1.1
Time frame: From first tumour assessment to progression/trial end (whichever is first), assessed up to 41 months
Adverse events
Time frame: From date of consent to 30 days after final trial treatment
Quality of life as measured by EQ-5D
Time frame: From baseline to progression/trial end (whichever is first), assessed up to 41 months
Quality of life as measured by QLQC-30
Time frame: From baseline to progression/trial end (whichever is first), assessed up to 41 months
Quality of life as measured by QLQ-LC-13
Time frame: From baseline to progression/trial end (whicenver is first), assessed up to 41 months
Compliance measured by dose intensity
Time frame: From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months
Compliance measured by dose exposure
Time frame: From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months
Results and safety
The study was stopped early (reason given: Low recruitment, lack of efficacy and increased adverse events in investigational arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Yes. On receipt of a request the recipient will consider the proposal, ensure relevant Chief Investigator/Trial Management Group are consulted and, if necessary, Trial Steering Committee and/or Cancer Trials Centre (CTC) Senior Management Group. Any shared data will be in an anonymised format
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Carboplatin and Etoposide in people with Small Cell Lung Cancer, run by University College, London at 13 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 14 inclusion and 16 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: stopped early, as of the sponsor's last update on 18 Mar 2021. 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 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?
The study was stopped early (reason given: Low recruitment, lack of efficacy and increased adverse events in investigational arm.). 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 (time frame: Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.