Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLCPhase 2NCT03022500
Pulmonary sarcomatoid_MEDI4736+Treme
A Phase 2 study testing durvalumab + tremelimumab in people with Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary sarcomatoid carcinoma Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC
- What is being tested?
- durvalumab + tremelimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 May 2017to 30 Nov 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years
- ECOG PS ≤1
- Patients with histologically confirmed NSCLC with the histology of sarcomatoid carcinoma (WHO criteria for sarcomatoid carcinoma is used; Carcinoma with spindle and/or giant cells, Pleomorphic carcinoma, Spindle cell carcinoma, Giant cell carcinoma, Carcinosarcoma, pulmonary blastoma. If the NSCLC patients showed sarcomatoid carcinoma histology in re-biopsy sample(so called epithelial-mesenchymal transition (EMT) phenomenon),the patients are eligible)
- Initial metastatic cases or recurrent cases after curative treatment (any chemotherapy line is allowed)
- A patient with at least one measurable lesion of which the diameter is confirmed to be ≥ 10mm in spiral CT or multi-detector CT (MD CT), or ≥ 20 mm in conventional CT (it should be used by a consistent method during the study period).
- If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
Show all 11Show fewer
- Adequate hematologic (neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3), hepatic (transaminase ≤ upper normal limit(UNL)x2.5, bilirubin level ≤ UNLx1.5), and renal (creatinine ≤ UNL) function
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages - Absolute neutrophil count 1,500 cells/mm3, platelets 100,000 cells/mm3
- Expected survival ≥ 3 months
- Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; or history of hysterectomy, or history of bilateral tubal ligation, or history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
Who cannot join
- A patient with no measurable disease
- chronic systemic steroid therapy or on any other form of immunosuppressive medication
- has received a live-virus vaccination within 30 days of planned treatment start
- history of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation
- active symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
Show all 20Show fewer
- active autoimmune disease within the past 2 years (NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment -within the past 2 years- are not excluded) or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or anti CTLA4 agents (including durvalumab and tremelimumab)
- active infection requiring therapy
- history of Human Immunodeficiency Virus (HIV)
- active Hepatitis B or C (inactive healthy carriers of HBV with appropriate prophylactic antiviral agents are allowed)
- symptomatic ascites or pleural effusion
- pneumonitis that has required a course of oral steroids to assist with recovery, or a history of interstitial lung disease
- pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
- History of active tuberculosis
- History of allogeneic organ transplant. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 21 days prior to the first dose of study drug
- History of allogeneic organ transplant
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Phase II Study of Durvalumab + Tremelimumab in Pulmonary Sarcomatoid Carcinoma
To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary sarcomatoid carcinoma
Read the detailed description
This is a phase II multi-center, open-label study to evaluate efficacy and safety of durvalumab + tremelimumab combination treatment in patients with pulmonary sarcomatoid carcinoma
- Being tested
- durvalumab + tremelimumab
- 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.
durvalumab + tremelimumabDrug
Durvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| durvalumab + tremelimumab | Experimental | Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity. Receives: Drug: durvalumab + tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (RR)
According to modified RECIST1.1, The duration from the first date of treatment to the date of death from any cause or follow-up
Measured: 12 months after the first date of treatment
Secondary outcomes (3)
Progression-Free Survival (PFS)
The percentage of patients who have not experienced disease progression or death from any cause within 12 months from the start of treatment.
Measured: 12 months after the first date of treatment
Overall Survival (OS)
The duration from the first date of treatment to the date of death from any cause or follow-up
Measured: 12 months after the first date of treatment
Safety
The number of patients with treatment-related AE as assessed by NCI CTCAE version 4.0
Measured: 12 months after the first date of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start18 May 2017
- Primary completion28 Feb 2018
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLCStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhumsuk Keam, Seoul National University Hospital
- Investigators
- Bhumsuk Kim, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022500
- Sponsor's protocol ID
- PSC
- Status last verified
- May 2024
- First submitted
- 13 Jan 2017
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anticipated as research paper
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Durvalumab + Tremelimumab in Pulmonary Sarcomatoid Carcinoma
- ClinicalTrials.gov ID
- NCT03022500
- Acronym / sponsor ID
- PSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 16 Jan 2017 (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.
To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary sarcomatoid carcinoma
Detailed description
This is a phase II multi-center, open-label study to evaluate efficacy and safety of durvalumab + tremelimumab combination treatment in patients with pulmonary sarcomatoid carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| durvalumab + tremelimumab | Experimental | Drug: durvalumab + tremelimumabDurvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 20 years
- ECOG PS ≤1
- Patients with histologically confirmed NSCLC with the histology of sarcomatoid carcinoma (WHO criteria for sarcomatoid carcinoma is used; Carcinoma with spindle and/or giant cells, Pleomorphic carcinoma, Spindle cell carcinoma, Giant cell carcinoma, Carcinosarcoma, pulmonary blastoma. If the NSCLC patients showed sarcomatoid carcinoma histology in re-biopsy sample(so called epithelial-mesenchymal transition (EMT) phenomenon),the patients are eligible)
- Initial metastatic cases or recurrent cases after curative treatment (any chemotherapy line is allowed)
- A patient with at least one measurable lesion of which the diameter is confirmed to be ≥ 10mm in spiral CT or multi-detector CT (MD CT), or ≥ 20 mm in conventional CT (it should be used by a consistent method during the study period).
Key exclusion criteria (20 listed)
- A patient with no measurable disease
- chronic systemic steroid therapy or on any other form of immunosuppressive medication
- has received a live-virus vaccination within 30 days of planned treatment start
- history of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation
- active symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
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 |
|---|---|---|
| durvalumab + tremelimumabDurvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity. | Drug | durvalumab + tremelimumab |
Primary outcome
Response rate (RR)
Time frame: 12 months after the first date of treatment
According to modified RECIST1.1, The duration from the first date of treatment to the date of death from any cause or follow-up
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 12 months after the first date of treatment
Overall Survival (OS)
Time frame: 12 months after the first date of treatment
Safety
Time frame: 12 months after the first date of treatment
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 29 May 2024.
- Individual participant dataSharing planned: Undecided. anticipated as research paper
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.
Bhumsuk Kim, Ph.D. principal investigator
Seoul National University Hospital
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 durvalumab + tremelimumab in people with Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC, run by Seoul National University Hospital at 1 site in South Korea.
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 11 inclusion and 20 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 29 May 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 South Korea. 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?
Response rate (RR) (time frame: 12 months after the first date of treatment). 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 29 May 2024.