Pulmonary sarcomatoid_MEDI4736+Treme

NCT03022500 | Completed Phase 2

• 1 other identifier: PSC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary sarcomatoid carcinoma

Conditions

Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

  12 months after the first date of treatment

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  12 months after the first date of treatment

• Overall Survival (OS)

  12 months after the first date of treatment

• Safety

  12 months after the first date of treatment

Study Arms (1)

durvalumab + tremelimumab

EXPERIMENTAL

Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.

Drug: durvalumab + tremelimumab

Interventions

durvalumab + tremelimumab DRUG

Durvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.

durvalumab + tremelimumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Internal Medicine, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; tremelimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bhumsuk Kim, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professo

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 16, 2017
• Study Start: May 18, 2017
• Primary Completion: February 28, 2018
• Study Completion: November 30, 2019
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

KR (1)