Lung Cancer, Non-Small CellPhase 1NCT00455572
Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer
A Phase 1 study testing Immunotherapeutic GSK1572932A, Cisplatin (CDDP) and Vinorelbine in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 26 sites in 6 countries.
Trial summary
The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. 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?
- Immunotherapeutic GSK1572932A, Cisplatin (CDDP) and Vinorelbine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 11 May 2007to 8 Aug 2013
- Phase
- Phase 1
- 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 obtained,
- Aged 18 or more,
- Pathologically proven stage IB, II or III NSCLC,
- Tumor expresses MAGE-A3,
- Free of distant metastasis,
- For Cohort 1, all of the following:
Show all 37Show fewer
- Completely resected stage IB, II or IIIA NSCLC,
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG performance status = 0 or 1
- Due to receive adjuvant chemotherapy as permitted in the protocol
- Not received, not receiving, and not due to receive adjuvant radiotherapy (except stage III patients)
- First administration of chemotherapy can be scheduled within 4-12 weeks after surgery
- For Cohort 2, all of the following:
- Resected stage IB, II or IIIA NSCLC,
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG PS = 0 or 1
- Due to receive, or receiving, adjuvant chemotherapy as permitted in the protocol
- Not received, not receiving, and not due to receive, adjuvant radiotherapy (except stage III patients)
- First administration of ASCI treatment can be scheduled within 2-4 weeks after the last administration of chemotherapy
- Received at least 2 cycles of standard chemotherapy before ASCI treatment is initiated, whereafter no further chemotherapy is planned
- For Cohort 3, all of the following:
- Resected stage IB, II or IIIA NSCLC
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG PS = 0 or 1 or 2
- Not received, not receiving, and not due to receive, adjuvant chemotherapy
- Not received, not receiving, and not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III)
- First administration of ASCI treatment can be scheduled within 4-8 weeks after surgery
- For Cohort 4, all of the following:
- Unresectable stage III NSCLC
- ECOG PS = 0 or 1 or 2
- Due to receive, or receiving, chemo- and radiotherapy according to institution standard
- Received at least 2 cycles of standard chemotherapy before the initiation of ASCI treatment, whereafter no further chemo-/radiotherapy is planned
- Stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy
- Administration of ASCI treatment can be scheduled within 2-6 weeks after the last administration of chemo-/radiotherapy
- Laboratory criteria: adequate bone-marrow reserve, adequate renal function, adequate hepatic function.
- For females: EITHER not of child-bearing potential, OR sexually abstinent, OR negative urine pregnancy test + use of adequate contraceptive precautions from 30 days before first study treatment till 2 months after completion of study treatment course
- In the view of the investigator, the patient can and will comply with the requirements of the protocol
Who cannot join
- Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
- Pregnant or lactating
- History of anaphylaxis or severe allergic reaction
- Concurrent severe medical problems, unrelated to the malignancy, limiting full compliance with the study or exposing the patient to unacceptable risk
- Psychiatric or addictive disorders compromising the ability to give informed consent, or to comply with the trial procedures
- HIV-positive
Show all 10Show fewer
- Require treatment with systemic corticosteroids, or other immunosuppressive agents
- Need home oxygenation
- Received or plan to receive investigational or non-registered product other than the study medication from 30 days before first dose of study medication and during whole study period
- History of chronic alcohol consumption and/or drug abuse
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
Germany6 sites
GSK Investigational Site
Bad Berka, Thuringia, 99437
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Halle, Saxony-Anhalt, 06120
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Hemer, North Rhine-Westphalia, 58675
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
Italy5 sites
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Milan, Lombardy, 20141
GSK Investigational Site
Rome, Lazio, 00152
GSK Investigational Site
Udine, Friuli Venezia Giulia, 33100
United Kingdom5 sites
GSK Investigational Site
Bebington, Wirral, CH63 4JY
GSK Investigational Site
London, SE1 9RT
GSK Investigational Site
Nottingham, NG5 1PB
GSK Investigational Site
Southampton, SO16 6YD
GSK Investigational Site
Wythenshawe, Greater Manchester, M23 9LT
France4 sites
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Saint-Herblain, 44805
GSK Investigational Site
Strasbourg, 67091
Belgium3 sites
GSK Investigational Site
Genk, 3600
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
Canada3 sites
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1
GSK Investigational Site
Montreal, Quebec, H4J 1C5
About this study
Official title: Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer
The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
This is an open, four-arm, parallel-group study, to be conducted at approximately 20 centers in Europe and Canada. All patients will receive the same immunotherapeutic treatment with GSK1572932A, but they will be recruited into four cohorts according to the details of their disease. Cohort 1: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel. Cohort 2: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy.
Cohort 3: Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. Cohort 4: Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. Immunotherapeutic treatment will comprise eight doses of GSK1572932A. Doses will be administered at three-week intervals; in Cohort 1 this may be adapted to fit in with the patient's chemotherapy. During the study, adjuvant radiotherapy is allowed in Cohorts 1, 2 and 3 for patients in stage III only and is prohibited in Cohort 4. Chemotherapy during the study is allowed in Cohort 1 only as described above, and is prohibited in Cohorts 2-4. The total maximum duration of the study for a patient will be 30-35 weeks.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Immunotherapeutic GSK1572932A, Cisplatin (CDDP), Vinorelbine, Radiotherapy
- Keywords
- Immunotherapeutic, Adjuvant cancer therapy, Non-small-cell lung cancer, ASCI
- 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.
Immunotherapeutic GSK1572932ABiological
Intramuscular injection, 8 doses
Cisplatin (CDDP)Drug
Four cycles with doses based on patient's body surface area, intravenous administration
VinorelbineDrug
Four cycles with doses based on patient's body surface area , intravenous administration
RadiotherapyProcedure or surgery
Regimen will be based upon the site's own standard procedures
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel. Receives: Biological: Immunotherapeutic GSK1572932A; Drug: Cisplatin (CDDP); Drug: Vinorelbine |
| Cohort 2 | Experimental | Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy Receives: Biological: Immunotherapeutic GSK1572932A; Drug: Cisplatin (CDDP); Drug: Vinorelbine |
| Cohort 3 | Experimental | Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. Receives: Biological: Immunotherapeutic GSK1572932A |
| Cohort 4 | Experimental | Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. Receives: Biological: Immunotherapeutic GSK1572932A; Drug: Cisplatin (CDDP); Drug: Vinorelbine; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anti-MAGE-A3 seroconversion
Measured: After the fourth dose of ASCI and at the end of treatment
The anti-protein D seroconversion
Measured: After the fourth dose of ASCI and at the end of treatment
The anti-CpG seroconversion
Measured: After the fourth dose of ASCI and at the end of treatment
The MAGE-A3 cellular (T cell) response
Measured: After the fourth dose of ASCI and at the end of treatment
Occurrence of adverse events, including abnormal hematological and biochemical laboratory values
Measured: During the study
Occurrence of serious adverse events
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study start11 May 2007
- Primary completion4 Aug 2013
- Study completion8 Aug 2013
Why it stopped: Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 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
- NCT00455572
- Sponsor's protocol ID
- 107240
- Status last verified
- May 2017
- First submitted
- 2 Apr 2007
- Last updated
- 15 May 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquee L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.
PubMed 26309191
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00455572
- Acronym / sponsor ID
- 107240
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- Immunotherapeutic, Adjuvant cancer therapy, Non-small-cell lung cancer, ASCI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 May 2007 (actual)
- Primary completion
- 4 Aug 2013 (actual)
- Study completion
- 8 Aug 2013 (actual)
- First posted
- 3 Apr 2007 (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.
The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This is an open, four-arm, parallel-group study, to be conducted at approximately 20 centers in Europe and Canada. All patients will receive the same immunotherapeutic treatment with GSK1572932A, but they will be recruited into four cohorts according to the details of their disease. Cohort 1: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel. Cohort 2: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy.
Cohort 3: Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. Cohort 4: Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. Immunotherapeutic treatment will comprise eight doses of GSK1572932A. Doses will be administered at three-week intervals; in Cohort 1 this may be adapted to fit in with the patient's chemotherapy. During the study, adjuvant radiotherapy is allowed in Cohorts 1, 2 and 3 for patients in stage III only and is prohibited in Cohort 4. Chemotherapy during the study is allowed in Cohort 1 only as described above, and is prohibited in Cohorts 2-4. The total maximum duration of the study for a patient will be 30-35 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Immunotherapeutic GSK1572932A, Drug: Cisplatin (CDDP), Drug: VinorelbinePatients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel. |
| Cohort 2 | Experimental | Biological: Immunotherapeutic GSK1572932A, Drug: Cisplatin (CDDP), Drug: VinorelbinePatients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy |
| Cohort 3 | Experimental | Biological: Immunotherapeutic GSK1572932APatients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. |
| Cohort 4 | Experimental | Biological: Immunotherapeutic GSK1572932A, Drug: Cisplatin (CDDP), Drug: Vinorelbine, Procedure: RadiotherapyPatients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Written informed consent obtained,
- Aged 18 or more,
- Pathologically proven stage IB, II or III NSCLC,
- Tumor expresses MAGE-A3,
- Free of distant metastasis,
Key exclusion criteria (10 listed)
- Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
- Pregnant or lactating
- History of anaphylaxis or severe allergic reaction
- Concurrent severe medical problems, unrelated to the malignancy, limiting full compliance with the study or exposing the patient to unacceptable risk
- Psychiatric or addictive disorders compromising the ability to give informed consent, or to comply with the trial procedures
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 |
|---|---|---|
| Immunotherapeutic GSK1572932AIntramuscular injection, 8 doses | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Cisplatin (CDDP)Four cycles with doses based on patient's body surface area, intravenous administration | Drug | Cohort 1, Cohort 2, Cohort 4 |
| VinorelbineFour cycles with doses based on patient's body surface area , intravenous administration | Drug | Cohort 1, Cohort 2, Cohort 4 |
| RadiotherapyRegimen will be based upon the site's own standard procedures | Procedure or surgery | Cohort 4 |
Primary outcome
The anti-MAGE-A3 seroconversion
Time frame: After the fourth dose of ASCI and at the end of treatment
The anti-protein D seroconversion
Time frame: After the fourth dose of ASCI and at the end of treatment
The anti-CpG seroconversion
Time frame: After the fourth dose of ASCI and at the end of treatment
The MAGE-A3 cellular (T cell) response
Time frame: After the fourth dose of ASCI and at the end of treatment
Occurrence of adverse events, including abnormal hematological and biochemical laboratory values
Time frame: During the study
Occurrence of serious adverse events
Time frame: During the study
Results and safety
The study was stopped early (reason given: Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 26309191Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquee L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.
- Results for study 107240 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- 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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immunotherapeutic GSK1572932A, Cisplatin (CDDP) and Vinorelbine in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 26 sites in 6 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 37 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: stopped early, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Italy, United Kingdom, France, Belgium and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the 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?
The anti-MAGE-A3 seroconversion (time frame: After the fourth dose of ASCI and at the end of treatment). The study lists 6 primary outcomes in all. 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 NCT00455572, 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 15 May 2017.