Lung Cancer, Non-Small CellPhase 2PEARLNCT01853878
A Study to Demonstrate the Benefit of a New Kind of Anti-cancer Treatment [PReferentially Expressed Antigen of MElanoma (PRAME) Immunotherapy] for Patients With Non-Small Cell Lung Cancer (NSCLC), After Removal of Their Tumor
A Phase 2 study testing Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 39 sites in 9 countries.
Trial summary
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer. Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell
- What is being tested?
- Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 39 sitesin 9 countries
- Study dates
- 12 Jun 2013to 24 Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient has radically resected NSCLC
- The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy The patient's tumor shows expression of PRAME.
- The patient is ≥ 18 years of age at the time of first consent.
- Written informed consent has been obtained from the patient prior to performance of any study-specific procedure.
- The patient is free of disease (no residual tumor, no loco-regional recurrence, no distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be performed as clinically indicated.
- Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 at the time of randomization
Show all 9Show fewer
- Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessed by standard laboratory criteria
- If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study product, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after last treatment administration.
- Patients who the investigator believes can and will comply with the requirements of this protocol (e.g. return for active follow-up visits).
Who cannot join
- The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years. Patients with effectively treated non - melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of which in remission for less than 5 years will be eligible.
- The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except for:
- Administration of adjuvant platinum-based doublet chemotherapy for the treatment of the current NSCLC allowed between surgery and randomization.
- Treatment of previous malignancies as allowed by the protocol.
- The patient has been diagnosed with a Potential Immune-Mediated Disease (pIMD). Patients with vitiligo are not excluded from the study.
- The patient has a history of confirmed adrenal dysfunction.
Show all 16Show fewer
- The patient requires concomitant treatment with any immunosuppressive agent, or with systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive days).
- The patient needs chronic long term oxygen therapy (LTOT). The patient has medically uncontrolled congestive heart failure or hypertension, unstable heart disease or uncontrolled arrhythmia at the time of randomization.
- The patient has an uncontrolled bleeding disorder.
- The patient has undergone splenectomy.
- The patient is known to be Human Immunodeficiency Virus (HIV)-positive.
- The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
- The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- The patient has received any investigational or non-registered product within the 30 days preceding randomization, or planned use during the study period.
- For female patients: the patient is pregnant or lactating or is planning to become pregnant.
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
Germany10 sites
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51109
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69126
GSK Investigational Site
Herne, North Rhine-Westphalia, 44623
GSK Investigational Site
Immenhausen, Hesse, 34376
GSK Investigational Site
Moers, North Rhine-Westphalia, 47441
GSK Investigational Site
Munich, Bavaria, 81925
GSK Investigational Site
Münster, North Rhine-Westphalia, 48153
GSK Investigational Site
Velbert, North Rhine-Westphalia, 42551
United States8 sites
GSK Investigational Site
Everett, Washington, 98201
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Paterson, New Jersey, 08759
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Springfield, Illinois, 62702
United Kingdom5 sites
GSK Investigational Site
Birmingham, B9 5SS
GSK Investigational Site
Cambridge, Cambridgeshire, CB23 3RE
GSK Investigational Site
Edinburgh, Midlothian, EH4 2XU
GSK Investigational Site
Manchester, M23 9LT
GSK Investigational Site
Sheffield, S10 2SJ
France4 sites
GSK Investigational Site
Créteil, 94010
GSK Investigational Site
Lyon, 69373
GSK Investigational Site
Marseille, 13915
GSK Investigational Site
Montpellier, 34295
Japan4 sites
GSK Investigational Site
Hyōgo, 673-8558
GSK Investigational Site
Kanagawa, 232-0024
GSK Investigational Site
Kanagawa, 241-8515
GSK Investigational Site
Shizuoka, 411-8777
Russia3 sites
GSK Investigational Site
Chelyabinsk, 454087
GSK Investigational Site
Saint Petersburg, 197 089
GSK Investigational Site
Saint Petersburg, 197758
Estonia2 sites
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 51014
Poland2 sites
GSK Investigational Site
Szczecin, 70-891
GSK Investigational Site
Zakopane, 34-500
About this study
Official title: GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.
Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. The participants were no longer enrolled in the study, the follow ups on subjects were stopped and the collection and analysis of samples for further research purposes was stopped.
Read more
After the stop to recruitment, the study was unblinded, as per the amended protocol, the study treatment was continued and completed with the subjects of the active treatment group who were willing to continue. Subjects in the placebo group were withdrawn.
There was no longer an active follow-up of patients after discontinuation or completion of the treatment. The study ended 30 days after the last dose was administered.
As a result, primary and secondary objectives were not assessed as planned. All clinical and safety data collected in the study were analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing was not performed by default, except if a scientific rationale remained relevant despite the premature termination of the study.
Read the detailed description
During the treatment period, safety monitoring continued as initially foreseen. Reporting of post-study adverse events (AEs) and serious AEs (SAEs) continued as per protocol. In the best interest of the patient, no more biological samples for protocol research purposes (i.e. serum sampling for humoral immunity, whole blood sampling for pharmacogenetics) were taken.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A, Placebo
- Keywords
- Non-Small Cell Lung Cancer, Immunotherapy, Antigen-Specific
- 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.
Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032ABiological
Intramuscular administration
PlaceboBiological
Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| GSK2302032A Group | Experimental | The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks. Receives: Biological: Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A |
| Placebo group | Placebo comparator | The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Occurrence of Any Recurrence of Disease
Time to occurrence of any recurrence of disease was expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T[year)]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies.
Measured: During the entire study (From Week 1 to Week 112)
Secondary outcomes (9)
Overall Survival (OS)
OS was defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive were censored at the last visit they are known to be alive. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.
Measured: During the entire study (From Week 1 to Week 112)
Lung-cancer-specific Survival
Lung-cancer specific survival was defined as defined as the interval from randomization to the date of death due to lung cancer; deaths due to other or unknown causes were censored at the date of death. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.
Measured: During the entire study (From Week 1 to Week 112)
Disease-free Specific Survival (DFSS)
DFSS was defined as the interval from randomization to the date of first recurrence of disease or date of death due to lung cancer, whichever occurs first. Patients without recurrence or death due to lung cancer were censored at the date of last assessment. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.
Measured: During the entire study (From Week 1 to Week 112)
DFS (Disease-free Survival) at 2, 3, 4 and 5 Years After Randomization
Defined as the time from randomization to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurred first. The 5-year active follow-up period planned in the initial study protocol was cancelled per Protocol Amendment 2, hence this analysis was not performed.
Measured: During the entire follow-up period (From year 2 to Year 5)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within the 31-day (Days 0-30) post-vaccine administration period
Anti-PRAME Antibody Concentrations
Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.
Measured: At each defined time point from Week 0 till Concluding Visit (Week 112)
Number of Subjects With Any Abnormal Hematological and Biochemical Parameters
Hematological and biochemical parameters assessed were tabulated by maximum grade versus baseline, by CTCAE = Common Terminology Criteria for Adverse Events version 4.0 (Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; Grade 5 = death; Grade Unknown) and by the type of abnormality (e.g. increased, decreased, prolonged, etc.). Some parameters (e.g. Anemia) already comprise within their definition the type of abnormality presented.
Measured: During the entire study period (From Week 1 to Week 112)
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE.
Measured: During the entire study (From Week 1 to Week 112)
Number of Subjects With Any Adverse Events (AEs) by Intensity Grade.
Grading was done as per the Common Terminology Criteria for Adverse Events (CTCAE) of the U.S. National Cancer Institute, version 4.0. The intensity grades assessed were: 1, 2, 3, 4, 5 and Unknown.
Measured: From Week 0 to Week 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study start12 Jun 2013
- Primary completion24 Aug 2016
- Study completion24 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853878
- Sponsor's protocol ID
- 116389
- Other IDs
- 2012-002790-55
- Acronym
- PEARL
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2013
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below).
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01853878
- Acronym / sponsor ID
- PEARL / 116389
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- Non-Small Cell Lung Cancer, Immunotherapy, Antigen-Specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 24 Aug 2016 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.
Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. The participants were no longer enrolled in the study, the follow ups on subjects were stopped and the collection and analysis of samples for further research purposes was stopped.
After the stop to recruitment, the study was unblinded, as per the amended protocol, the study treatment was continued and completed with the subjects of the active treatment group who were willing to continue. Subjects in the placebo group were withdrawn.
There was no longer an active follow-up of patients after discontinuation or completion of the treatment. The study ended 30 days after the last dose was administered.
As a result, primary and secondary objectives were not assessed as planned. All clinical and safety data collected in the study were analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing was not performed by default, except if a scientific rationale remained relevant despite the premature termination of the study.
Detailed description
During the treatment period, safety monitoring continued as initially foreseen. Reporting of post-study adverse events (AEs) and serious AEs (SAEs) continued as per protocol. In the best interest of the patient, no more biological samples for protocol research purposes (i.e. serum sampling for humoral immunity, whole blood sampling for pharmacogenetics) were taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2302032A Group | Experimental | Biological: Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032AThe patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks. |
| Placebo group | Placebo comparator | Biological: PlaceboThe patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient has radically resected NSCLC
- The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy The patient's tumor shows expression of PRAME.
- The patient is ≥ 18 years of age at the time of first consent.
- Written informed consent has been obtained from the patient prior to performance of any study-specific procedure.
- The patient is free of disease (no residual tumor, no loco-regional recurrence, no distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be performed as clinically indicated.
Key exclusion criteria (16 listed)
- The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years. Patients with effectively treated non - melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of which in remission for less than 5 years will be eligible.
- The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except for:
- The patient has been diagnosed with a Potential Immune-Mediated Disease (pIMD). Patients with vitiligo are not excluded from the study.
- The patient has a history of confirmed adrenal dysfunction.
- The patient requires concomitant treatment with any immunosuppressive agent, or with systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive days).
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 |
|---|---|---|
| Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032AIntramuscular administration | Biological | GSK2302032A Group |
| PlaceboIntramuscular administration | Biological | Placebo group |
Primary outcome
Time to Occurrence of Any Recurrence of Disease
Time frame: During the entire study (From Week 1 to Week 112)
Time to occurrence of any recurrence of disease was expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T[year)]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies.
9 secondary outcomes
Overall Survival (OS)
Time frame: During the entire study (From Week 1 to Week 112)
Lung-cancer-specific Survival
Time frame: During the entire study (From Week 1 to Week 112)
Disease-free Specific Survival (DFSS)
Time frame: During the entire study (From Week 1 to Week 112)
DFS (Disease-free Survival) at 2, 3, 4 and 5 Years After Randomization
Time frame: During the entire follow-up period (From year 2 to Year 5)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) post-vaccine administration period
Anti-PRAME Antibody Concentrations
Time frame: At each defined time point from Week 0 till Concluding Visit (Week 112)
Number of Subjects With Any Abnormal Hematological and Biochemical Parameters
Time frame: During the entire study period (From Week 1 to Week 112)
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: During the entire study (From Week 1 to Week 112)
Number of Subjects With Any Adverse Events (AEs) by Intensity Grade.
Time frame: From Week 0 to Week 112
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below).
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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.
GSK Clinical Trials study director
GlaxoSmithKline
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 39 sites in 9 countries.
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 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: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, United States, United Kingdom, France, Japan and 4 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Occurrence of Any Recurrence of Disease (time frame: During the entire study (From Week 1 to Week 112)). 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 28 Aug 2019.