NSCLC Stage IIIA/BPhase 2NCT02118415
Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
A Phase 2 study testing Hsp70-peptide TKD/IL-2 activated, autologous NK cells in people with NSCLC Stage IIIA/B, run by Technical University of Munich at 1 site in Germany.
Trial summary
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Stage IIIA/B
- What is being tested?
- Hsp70-peptide TKD/IL-2 activated, autologous NK cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Mar 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First diagnosis of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B
- Completion of radiochemotherapy no longer than 8 weeks ago
- Progression free according to RECIST criteria at the first assessment after completion of RCTx
- Confirmed presence of Hsp70 on patient´s tumors
- ECOG Status(Appendices) ≤ 2
Who cannot join
- Any severe heart disease or any severe concomitant disease (ECOG stage > 2)
- NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdisciplinary tumorboard
- Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
- Patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology
- Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
Munich, 81675
About this study
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
Read the detailed description
Patients with non-small cell lung carcinoma (NSCLC) in stage III A and III B showing at least stable disease after RCTx will be enrolled into the clinical trial. The aim of the study is to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine). Patients will be randomized 1:1 either to the interventional study group to receive 4 cycles of autologous immunotherapy with activated NK cells or to the control group (BSC).
- Conditions
- NSCLC Stage IIIA/B
- Being tested
- Hsp70-peptide TKD/IL-2 activated, autologous NK cells
- Keywords
- not eligible for surgery, efficacy of immunotherapy following RCTx
- 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.
Hsp70-peptide TKD/IL-2 activated, autologous NK cellsOther
Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Interventional group: activated autologous NK cells as a drug Receives: Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells |
| Control group | No intervention | Control group: BSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Measured: follow up after randomization for at least 18 months
Secondary outcomes (4)
overall survival (OS)
Measured: follow up after randomization for at least 18 months
toxicity (AE and SAE)
Measured: follow up after randomization for at least 18 months
quality of life (QoLQ-30, LC-13)
Measured: follow up after randomization for at least 18 months
biological parameters (NK cell activation)
Measured: follow up after randomization for at least 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completion28 Mar 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIA/BStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Model description
- Participants of the intervention group receive biological product (ex vivo activated, autologous NK cells), participants of the control group receive no biological product
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118415
- Sponsor's protocol ID
- NSCLC-TKD/IL-2
- Other IDs
- 2008-002130-30, 2008
- Status last verified
- Nov 2023
- First submitted
- 25 Feb 2014
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
- ClinicalTrials.gov ID
- NCT02118415
- Acronym / sponsor ID
- NSCLC-TKD/IL-2
- Conditions
- NSCLC Stage IIIA/B
- Keywords
- not eligible for surgery, efficacy of immunotherapy following RCTx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Apr 2014 (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.
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
Detailed description
Patients with non-small cell lung carcinoma (NSCLC) in stage III A and III B showing at least stable disease after RCTx will be enrolled into the clinical trial. The aim of the study is to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine). Patients will be randomized 1:1 either to the interventional study group to receive 4 cycles of autologous immunotherapy with activated NK cells or to the control group (BSC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants of the intervention group receive biological product (ex vivo activated, autologous NK cells), participants of the control group receive no biological product
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cellsInterventional group: activated autologous NK cells as a drug |
| Control group | No intervention | –Control group: BSC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First diagnosis of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B
- Completion of radiochemotherapy no longer than 8 weeks ago
- Progression free according to RECIST criteria at the first assessment after completion of RCTx
- Confirmed presence of Hsp70 on patient´s tumors
- ECOG Status(Appendices) ≤ 2
Key exclusion criteria (5 listed)
- Any severe heart disease or any severe concomitant disease (ECOG stage > 2)
- NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdisciplinary tumorboard
- Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
- Patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology
- Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium
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 |
|---|---|---|
| Hsp70-peptide TKD/IL-2 activated, autologous NK cellsAdjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine) | Other | Interventional |
Primary outcome
Progress free survival
Time frame: follow up after randomization for at least 18 months
4 secondary outcomes
overall survival (OS)
Time frame: follow up after randomization for at least 18 months
toxicity (AE and SAE)
Time frame: follow up after randomization for at least 18 months
quality of life (QoLQ-30, LC-13)
Time frame: follow up after randomization for at least 18 months
biological parameters (NK cell activation)
Time frame: follow up after randomization for at least 18 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 Apr 2024.
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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 Hsp70-peptide TKD/IL-2 activated, autologous NK cells in people with NSCLC Stage IIIA/B, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 5 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 Apr 2024. 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 Germany. 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?
Progress free survival (time frame: follow up after randomization for at least 18 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 17 Apr 2024.