MK-3475 vs. Docetaxel in Second-Line Non-Small Cell Lung Cancer
- Conditions
- ung cancerMedDRA version: 20.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004391-19-DK
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 920
1) Be willing and able to provide written informed consent/assent for the trial.
2) Be =18 years of age on day of signing informed consent.
3) Have a life expectancy of at least 3 months.
4) Have a histologically or cytologically confirmed diagnosis of nonsmall cell lung cancer (NSCLC) and have at least one measurable lesion as defined by RECIST 1.1 (Response Evaluation Criteria in Solid Tumours). The target lesion(s) shoud also have bi-dimensional measurability for ummune related response criteria evaluation on study
5) Have experienced investigator determined radiographic progression per RECIST 1.1 of NSCLC after treatment with at least two cycles of a platinumcontaining doublet for stage IIIB/IV or recurrent disease. The site’s study team must have reviewed pretrial images that are of diagnostic quality from at least 2 dates to confirm that radiographic progression has occurred per RECIST 1.1 following initiation of the firstline platinumcontaining doublet. The central imaging vendor must have received these scans and have conrifmed that they are of acceptable diagnostic quality prior to randomization in this trial for a possible retrospective analysis of this eligibility criterion. The central vendor will not be confirming eligibility prior to randomization. Completion of treatment with a platinumcontaining doublet as adjuvant therapy within one year of signing informed consent will satisfy the prior treatment requirement.
6) Have a performance status of 0 or 1 on the ECOG Performance Scale (Eastern Cooperative Oncology Group). This is a scale of how the disease effects daily activities. 0 or 1 is normal activity or symptoms but ambulatory.
7) Have adequate organ function as indicated in the protocol
8) Have provided tissue for biomarker analysis from a newly obtained formalin fixed tumor tissue sample from a recent biopsy of a tumor lesion not previously irradiated; no systemic antineoplastic therapy may be administered between the PD-L1 biopsy and initiating study medication. Although patients using tyrosine kinase inhibitors prior to treatment on this protocol may continue using these until it is time to begin the appropriate wash out period for these medications. For patients in whom obtaining a new tumorbiopsy will be medically inappropriate, the investigator may appeasl to the Sponsor's study clinical director, an if there is agreement, the investigator may submit an archival formalin-fixed. paraffin embedded rumor specimen for PD-L1 analysis. The Tissue sample must be received and evaluated by the central vendor prior to randomization. Fine needle aspirates are not acceptable. Needle or excisional biopsies, or resected tissue is required.
9) Have a PDL1 positive tumour as determined by a central laboratory
10) Have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If subject received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
11) Female subject of childbearing potential has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be
negative for the subject to be eligible.
12) Female subjects may be enrolled in the trial if they are:
- of nonchildbearing potential a female who is status post hysterectomy, oophorectomy or tubal ligation.
- of ch
1) Has received prior therapy with docetaxel for NSCLC.
2) Is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of trial treatment. The 30 day window should be applied to the last dose of an antineoplastic investigational agent or last use of an investigational device with antineoplastic intent.
3) Is receiving systemic steroid therapy within three days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication (corticosteroid use on study for management of ECIies or as a premedication
for docetaxel is allowed).
4) Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC or radiation therapy).
3) Is receiving systemic steroid therapy within three days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication (corticosteroid use on study for management of ECIies or as a premedication for docetaxel is allowed).
4) Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC or radiation therapy).
5) Has received prior systemic cytotoxic chemotherapy, biological therapy (e.g., cetuximab), major surgery or received radiation therapy of > 30 Gy within 3 weeks of the first dose of trial treatment; received prior kinase inhibitor therapy or palliative radiotherapy of 30Gy or less within 7 days of the first dose of trial treatment.
6) Has received prior therapy with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCytotxic Tlymphocyteassociated antigen4 (CTLA4) antibody including ipilimumab or any other antibody or drug specifically targeting Tcell costimulation or checkpoint pathways). Has participated in another MK3475
clinical trial.
7) Has a known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
Note: The time requirement for no evidence of disease for 5 years does not apply to the tumor for which a subject is enrolled in the trial. The time requirement also does not apply to subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer.
8) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by MRI for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are using no steroids for at least three days prior to study medication.
9) Has an active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method