Carcinoma, Non-Small-Cell LungPhase 3START2NCT02049151
Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer
A Phase 3 study testing Tecemotide, Cyclophosphamide (CPA) and Saline (sodium chloride) in people with Carcinoma, Non-Small-Cell Lung, run by EMD Serono at 2 sites in 2 countries.
Trial summary
This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Tecemotide, Cyclophosphamide (CPA) and Saline (sodium chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Jul 2015
- Phase
- Phase 3
- 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
- Written informed consent, before any trial-related activities are carried out
- Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan
- Prior concurrent CRT which is defined as follows:
- Minimum of 2 cycles of platinum-based chemotherapy
- Radiotherapy with a total tumor dose greater than equal to (>=) 60 Gray and a single fraction dose >= 1.8 Gray
- Overlap of radiotherapy with minimum 2 cycles of platinum-based chemotherapy (one cycle is defined as either 3 or 4 weeks depending on the chemotherapy regimen). A deviation of 2 to 3 days from an exact overlap is acceptable. Purely radiosensitizing doses of chemotherapy are not acceptable (for example [e.g.], daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
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- Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible.
- Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol
- Male or female, greater than or equal to 18 years of age
- Other protocol defined inclusion criteria could apply
Who cannot join
- Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT
- Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
- Metastatic disease
- Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry
- Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies
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- Splenectomy
- Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
- Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization
- Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks prior to randomization
- Autoimmune disease
- Active or chronic infectious hepatitis
- Infectious process that, in the opinion of the Investigator, could compromise the subject's ability to mount an immune response
- Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol
- Pregnant or breast-feeding women
- Known drug abuse/alcohol abuse
- Participation in another interventional clinical trial within the past 28 days (excluding purely observational studies)
- Requires concurrent treatment with a non-permitted drug
- Known hypersensitivity to any of the trial treatment ingredients
- Legal incapacity or limited legal capacity
- Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Please Contact U.S. Medical Information Located in
Rockland, Massachusetts
Germany1 site
Please contact the Merck KGaA Communication Center Located in
Darmstadt
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Tecemotide, Placebo, Cyclophosphamide (CPA), Saline (sodium chloride)
- Keywords
- Carcinoma, Non-Small-Cell Lung, Tecemotide, Placebo, NSCLC, L-BLP25
- 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.
TecemotideDrug
Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
PlaceboDrug
Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
Cyclophosphamide (CPA)Drug
CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.
Saline (sodium chloride)Drug
Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent [%] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Tecemotide | Experimental | Not described Receives: Drug: Tecemotide; Drug: Cyclophosphamide (CPA) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Saline (sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.
Measured: Time from date of randomization until death, assessed maximum up to 16 months
Secondary outcomes (4)
Time to Symptom Progression (TTSP)
TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks.
Measured: Time from date of randomization until progressive disease (PD), assessed up to 16 months
Progression Free Survival (PFS)
PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment.
Measured: Time from date of randomization until PD or death, assessed up to 16 months
Time to Progression (TTP)
TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death.
Measured: Time from date of randomization until PD, assessed up to 16 months
Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI-CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported.
Measured: Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC
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 Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049151
- Sponsor's protocol ID
- EMR 63325-021
- Other IDs
- 2013-003760-30
- Acronym
- START2
- Status last verified
- Jul 2017
- First submitted
- 27 Jan 2014
- Last updated
- 23 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02049151
- Acronym / sponsor ID
- START2 / EMR 63325-021
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Tecemotide, Placebo, NSCLC, L-BLP25
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC
- Enrolment
- 35 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.
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 |
|---|---|---|
| Tecemotide | Experimental | Drug: Tecemotide, Drug: Cyclophosphamide (CPA) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Saline (sodium chloride) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent, before any trial-related activities are carried out
- Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan
- Prior concurrent CRT which is defined as follows:
- Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible.
- Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
Key exclusion criteria (22 listed)
- Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT
- Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
- Metastatic disease
- Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry
- Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
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 |
|---|---|---|
| TecemotideTecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression. | Drug | Tecemotide |
| PlaceboMatching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression. | Drug | Placebo |
| Cyclophosphamide (CPA)CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide. | Drug | Tecemotide |
| Saline (sodium chloride)Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent [%] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo. | Drug | Placebo |
Primary outcome
Overall Survival
Time frame: Time from date of randomization until death, assessed maximum up to 16 months
Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.
4 secondary outcomes
Time to Symptom Progression (TTSP)
Time frame: Time from date of randomization until progressive disease (PD), assessed up to 16 months
Progression Free Survival (PFS)
Time frame: Time from date of randomization until PD or death, assessed up to 16 months
Time to Progression (TTP)
Time frame: Time from date of randomization until PD, assessed up to 16 months
Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)
Time frame: Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tecemotide, Cyclophosphamide (CPA) and Saline (sodium chloride) in people with Carcinoma, Non-Small-Cell Lung, run by EMD Serono at 2 sites in 2 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 12 inclusion and 22 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 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 30 Mar 2017). 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?
Overall Survival (time frame: Time from date of randomization until death, assessed maximum up to 16 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 23 Aug 2017.