Non Small Cell Lung CancerPhase 2CSET 1437NCT01159288
Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes
A Phase 2 study testing Dex2 in people with Non Small Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Dex2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2010to 19 Dec 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced unresectable non small cell lung cancer
- responding or stabilizer after induction chemotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes on Patients With Unresectable Non Small Cell Lung Cancer Responding to Induction Chemotherapy
Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Dex2
- Keywords
- Advanced unresectable non small cell lung cancer, Responding or stabilized after induction chemotherapy
- 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.
Dex2Biological
- Metronomic dosage of Cyclophosphamide during 3 weeks (50mg/day orally) as reported 15, before specific treatment.
- Induction immunotherapyIntradermal injections of Dex once a week during 4 consecutive weeks.(Peptides pulsed onto DC, sources of Dex: PRS pan-DR, MAGE-3 DP04, MAGE-1 A2, MAGE-3 A2, NY-ESO-1 A2 et MART-1 A2)
- Continuation Immunotherapy: Intradermal injections of Dex every two weeks during 6 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study start19 May 2010
- Primary completion19 Dec 2015
- Study completion19 Dec 2015
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 Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159288
- Sponsor's protocol ID
- IGR Dex2
- Acronym
- CSET 1437
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2010
- Last updated
- 17 Aug 2026
- Results posted
- No
Publications
Besse B, Charrier M, Lapierre V, Dansin E, Lantz O, Planchard D, Le Chevalier T, Livartoski A, Barlesi F, Laplanche A, Ploix S, Vimond N, Peguillet I, Thery C, Lacroix L, Zoernig I, Dhodapkar K, Dhodapkar M, Viaud S, Soria JC, Reiners KS, Pogge von Strandmann E, Vely F, Rusakiewicz S, Eggermont A, Pitt JM, Zitvogel L, Chaput N. Dendritic cell-derived exosomes as maintenance immunotherapy after first line chemotherapy in NSCLC. Oncoimmunology. 2015 Aug 12;5(4):e1071008. doi: 10.1080/2162402X.2015.1071008. eCollection 2016 Apr.
PubMed 27141373
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes on Patients With Unresectable Non Small Cell Lung Cancer Responding to Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT01159288
- Acronym / sponsor ID
- CSET 1437 / IGR Dex2
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Advanced unresectable non small cell lung cancer, Responding or stabilized after induction chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 19 May 2010 (actual)
- Primary completion
- 19 Dec 2015 (actual)
- Study completion
- 19 Dec 2015 (actual)
- First posted
- 9 Jul 2010 (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.
Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- advanced unresectable non small cell lung cancer
- responding or stabilizer after induction chemotherapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dex2* Metronomic dosage of Cyclophosphamide during 3 weeks (50mg/day orally) as reported 15, before specific treatment. * Induction immunotherapyIntradermal injections of Dex once a week during 4 consecutive weeks.(Peptides pulsed onto DC, sources of Dex: PRS pan-DR, MAGE-3 DP04, MAGE-1 A2, MAGE-3 A2, NY-ESO-1 A2 et MART-1 A2) * Continuation Immunotherapy: Intradermal injections of Dex every two weeks during 6 weeks. | Biological | – |
Primary outcome
Progression free survival
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 27141373Besse B, Charrier M, Lapierre V, Dansin E, Lantz O, Planchard D, Le Chevalier T, Livartoski A, Barlesi F, Laplanche A, Ploix S, Vimond N, Peguillet I, Thery C, Lacroix L, Zoernig I, Dhodapkar K, Dhodapkar M, Viaud S, Soria JC, Reiners KS, Pogge von Strandmann E, Vely F, Rusakiewicz S, Eggermont A, Pitt JM, Zitvogel L, Chaput N. Dendritic cell-derived exosomes as maintenance immunotherapy after first line chemotherapy in NSCLC. Oncoimmunology. 2015 Aug 12;5(4):e1071008. doi: 10.1080/2162402X.2015.1071008. eCollection 2016 Apr.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dex2 in people with Non Small Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 2 inclusion and 0 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 4 months). 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 NCT01159288, 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 17 Aug 2026.