MK-3475 vs. Docetaxel in Second-Line Non-Small Cell Lung Cancer
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Progression of non-small cell lung cancerMedDRA version: 21.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864
- Registration Number
- EUCTR2012-004391-19-DE
- 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 non-small cell lung cancer (NSCLC) and have at least one measurable lesion as defined by RECIST 1.1.
5) Have experienced investigator determined radiographic progression per RECIST 1.1 of NSCLC after treatment with a platinum-containing doublet for stage IIIB/IV or recurrent disease. The site’s study team must have reviewed pre-trial images that are of diagnostic quality from at least 2 dates to determine that radiographic progression has occurred per RECIST 1.1 following initiation of the first-line platinum-containing doublet. A platinum-containing doublet is defined as a platinum-based cytotoxic systemic agent administered in the same cycle as another cytotoxic systemic chemotherapeutic agent. The central imaging vendor must have received these scans 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 platinum-containing doublet as adjuvant therapy within one year of signing informed consent will satisfy the prior treatment requirement.
a. (see protocol amendment 03, page 27)
b. (see protocol amendment 03, page 27)
6) Have a performance status of 0 or 1 on the ECOG Performance Scale.
7) Have adequate organ function as indicated in Table 1 (see protocol amendment 03, page 28)
8) Have provided tissue for biomarker analysis from a formalin fixed paraffin embedded tumor tissue sample or a newly obtained formalin fixed tumor tissue from a recent biopsy of a tumor lesion not previously irradiated; newly obtained formalin fixed specimens are encouraged. If new scientific data emerge that indicate that an existing biopsy or surgical specimen is suboptimal for identification of patients, then only new biopsies will be acceptable for determination of PD-L1 status. The tissue sample must be received by the central vendor prior to randomization. Fine needle aspirates are not acceptable. Needle or excisional biopsies, or resected tissue is required.
a. Investigators must be able to produce the source documentation of the EGFR mutation status or ALK translocation status. If unable to test for these molecular changes, formalin fixed paraffin embedded tumor tissue of any age should be submitted to a central laboratory designated by the Sponsor for such testing. Subjects will not be randomized until EGFR mutation and ALK translocation status is available in source documentation at the site.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 552
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 368
The subject must be excluded from participating in the trial if the subject:
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.
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 ECIs or as a pre-medication 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 maintenance chemotherapy (chemotherapy for subjects with a stable or better response to the prior line of treatment) with an additional agent other than that used in the first-line regimen (switch maintenance). The exception to this rule is the patient who has an EGFR sensitizing mutation in the tumor who is treated with four cycles of a platinum doublet chemotherapy followed by an EGFR tyrosine kinase inhibitor.
6) Has received prior systemic cytotoxic chemotherapy, biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of trial treatment; received radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment; received prior tyrosine kinase inhibitor therapy or palliative radiotherapy of 30Gy or less within 7 days of the first dose of trial treatment.
7) Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways).
8) 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.
9) Has known active central nervous system (CNS) metastases and/or carcinom atous 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.
10) 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 from the study. Subjects with hypothyroidism stable on hormone replacemen
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