Metastatic Squamous Non-small Cell Lung CancerPhase 2PRIMUSNCT02564380
Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
A Phase 2 study testing Pembrolizumab in people with Metastatic Squamous Non-small Cell Lung Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Squamous Non-small Cell Lung Cancer
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jan 2016to 23 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient, age ≥ 18 years
- Signed informed consent
- Ability to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- At least one measurable tumor lesion according to RECIST 1.1
- Histologically or cytologically confirmed diagnosis of stage IV (AJCC Version 7) squamous non-small cell lung carcinoma
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- Complete response, partial response or stable disease after at least 2 cycles of first-line chemotherapy with cisplatin or carboplatin
- Last administration of platinum based first-line chemotherapy ≤ 5 +/- 1 week(s) prior first dose of study treatment
- Tumor specimen before first-line chemotherapy available for immunohistochemistry (IHC) of PD-L1 at a central laboratory. Tumor specimen must be a tumor block not a pre-cut slide.
- Adequate bone-marrow and organ function:
- Absolute neutrophil count ≥ 1.5 x 10^9/L and
- Thrombocytes ≥ 100 x 10^9/L and
- Hemoglobin ≥ 9 g/dL
- International Normalized Ratio (for blood clotting time) (INR) ≤ 1.5 and Partial Thromboplastin Time (PPT) ≤ 1.5 x upper limit during the last 7 days before therapy
- Bilirubin < 1.5 x Upper Limit of Normal (ULN) and
- Aspartate aminotransferase ((AST (GOT)) and Alanine aminotransferase ((ALT) (GPT)) < 3 x ULN (5 x ULN in case of liver metastases)
- Creatinine ≤ 1.5 x upper limit or creatinine clearance ≥ 45 mL/min (after first line chemotherapy)
- In female patients of childbearing potential (i.e. did not undergo surgical sterilization - hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and is not post-menopausal for at least 24 consecutive months), a negative pregnancy test at screening
- Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 adequate barrier methods of contraception during study treatment and for 120 days after last administration of study drug
Who cannot join
- Patients with any of the following will not be eligible for the study:
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start. It is permissable that a patient is in the follow-up phase of any previous study.
- Patient received systemic steroid therapy within three days prior to the first dose of study treatment or received any other form of immunosuppressive medication
- History of allogeneic tissue/solid organ transplant
- History of pneumonitis or interstitial lung disease that has required oral or i.v. steroids
- Radiotherapy of target lesion ≤ 28 days prior first dose of study treatment
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- Major surgery ≤ 28 days prior first dose of study treatment
- Minor surgery (e.g. venous catheter) ≤ 24 hours prior first dose of study treatment
- Cardiovascular or cerebrovascular disease of clinical relevance: e.g. acute myocardial infarction or stroke during the last 6 months, unstable angina, relevant and unstable dysrhythmia (controlled Tachyarrhythmia absoluta (TAA) allowed).
- Wound healing disorders, active ulcus ventriculi/duodenal ulcer, bone fracture
- Known active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or HIV infection
- Has any other active infection requiring systemic therapy.
- Patients with active tuberculosis
- Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Female patient pregnant or breastfeeding, or expecting to conceive or father children during the study and through 120 days after last administration of study drug
- Indications of a neurological or other disease, which may influence the feasibility of the study or may seriously disturb tolerability
- A diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Patient has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. [Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.]
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- Has known hypersensitivity to pembrolizumab or any of its insipients.
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 Arzneimittelgesetz (AMG).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC).
Read the detailed description
Patients with squamous non-small cell lung cancer and an ECOG of 0-1 who received a first-line therapy with Cis-/Carboplatin for at least 2 cycles that had at least Complete Response (CR) / Partial Response (PR) / Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 will be randomized either to Arm A Pembrolizumab or to Arm B Placebo for a maximum of 2 years or until progressive disease or unacceptable toxicity.
The aim is to investigate the efficacy of Pembrolizumab vs. placebo in terms of progression-free survival in patients with metastatic squamous, non-small cell lung cancer. Furthermore to evaluate tumor response, survival, tolerability and safety as well as quality of life of patients receiving Pembrolizumab.
- Being tested
- Pembrolizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pembrolizumab | Experimental | Pembrolizumab 200 mg every three weeks until disease progression (maximum 2 years) Receives: Drug: Pembrolizumab |
| Arm B: Placebo | Placebo comparator | Placebo i.v. every three weeks until disease progression (maximum 2 years) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
progression-free survival according to RECIST 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
Secondary outcomes (6)
overall response rate (ORR)
Efficacy measure
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
overall survival
Efficacy measure
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
PD-L1 expression in tumor samples
assessment of the prognostic value of PD-L1 expression in tumor samples obtained prior to study enrollment
Measured: samples at baseline taken ; collection up to 35 months
Safety (adverse events graded according to US NCI Common terminology criteria for adverse events)
Safety (intensity and incidence of adverse events, graded according to US NCI Common terminology criteria for adverse events (CTCAE) Version 4.03)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
Functional Assessment of Cancer Therapy for patients with Lung cancer
with the FACT-L questionnaire as part of the quality of life assessment
Measured: every 6 weeks until EOT for approx. 7 months
Lung Cancer Symptom Scale (LCSS)
as part of the quality of life assessment
Measured: every 6 weeks until EOT for approx. 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start19 Jan 2016
- Primary completion23 May 2020
- Study completion23 Nov 2020
Why it stopped: Since trial start in Jan. 2016 only 41 patients could be recruited until planned date of end of follow up period. Under consideration of this fact the recruitment of the planned 130 patients was not possible within a reasonable recruitment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Squamous Non-small Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Martin Reck, PD Dr., Principal investigator, LungenClinic Grosshansdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564380
- Sponsor's protocol ID
- AIO-TRK-0115
- Acronym
- PRIMUS
- Status last verified
- Dec 2021
- First submitted
- 10 Sep 2015
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
- ClinicalTrials.gov ID
- NCT02564380
- Acronym / sponsor ID
- PRIMUS / AIO-TRK-0115
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since trial start in Jan. 2016 only 41 patients could be recruited until planned date of end of follow up period. Under consideration of this fact the recruitment of the planned 130 patients was not possible within a reasonable recruitment period.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 23 May 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 30 Sep 2015 (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.
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC).
Detailed description
Patients with squamous non-small cell lung cancer and an ECOG of 0-1 who received a first-line therapy with Cis-/Carboplatin for at least 2 cycles that had at least Complete Response (CR) / Partial Response (PR) / Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 will be randomized either to Arm A Pembrolizumab or to Arm B Placebo for a maximum of 2 years or until progressive disease or unacceptable toxicity.
The aim is to investigate the efficacy of Pembrolizumab vs. placebo in terms of progression-free survival in patients with metastatic squamous, non-small cell lung cancer. Furthermore to evaluate tumor response, survival, tolerability and safety as well as quality of life of patients receiving Pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Pembrolizumab | Experimental | Drug: PembrolizumabPembrolizumab 200 mg every three weeks until disease progression (maximum 2 years) |
| Arm B: Placebo | Placebo comparator | Drug: PlaceboPlacebo i.v. every three weeks until disease progression (maximum 2 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patient, age ≥ 18 years
- Signed informed consent
- Ability to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- At least one measurable tumor lesion according to RECIST 1.1
Key exclusion criteria (23 listed)
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start. It is permissable that a patient is in the follow-up phase of any previous study.
- Patient received systemic steroid therapy within three days prior to the first dose of study treatment or received any other form of immunosuppressive medication
- History of allogeneic tissue/solid organ transplant
- History of pneumonitis or interstitial lung disease that has required oral or i.v. steroids
- Radiotherapy of target lesion ≤ 28 days prior first dose of study treatment
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 |
|---|---|---|
| PembrolizumabAlso: MK-3475 | Drug | Arm A: Pembrolizumab |
| Placebo | Drug | Arm B: Placebo |
Primary outcome
progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
progression-free survival according to RECIST 1.1
6 secondary outcomes
overall response rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
PD-L1 expression in tumor samples
Time frame: samples at baseline taken ; collection up to 35 months
Safety (adverse events graded according to US NCI Common terminology criteria for adverse events)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months.
Functional Assessment of Cancer Therapy for patients with Lung cancer
Time frame: every 6 weeks until EOT for approx. 7 months
Lung Cancer Symptom Scale (LCSS)
Time frame: every 6 weeks until EOT for approx. 7 months
Results and safety
The study was stopped early (reason given: Since trial start in Jan. 2016 only 41 patients could be recruited until planned date of end of follow up period. Under consideration of this fact the recruitment of the planned 130 patients was not possible within a reasonable recruitment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Description: Working Group for Medical Oncology (AIO) from the German Cancer Society (DKG)Link provided by the sponsor.
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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.
Martin Reck, PD Dr. principal investigator
LungenClinic Grosshansdorf
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 Pembrolizumab in people with Metastatic Squamous Non-small Cell Lung Cancer, run by AIO-Studien-gGmbH 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 19 inclusion and 23 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 4 Jan 2022. 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. 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?
The study was stopped early (reason given: Since trial start in Jan. 2016 only 41 patients could be recruited until planned date of end of follow up period. Under consideration of this fact the recruitment of the planned 130 patients was not possible within a reasonable recruitment period.). 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?
progression-free survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 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 4 Jan 2022.