None listed
Conditions
Interventions
Drug : Arm a : pembrolizumab plus chemotherapy (Gemcitabine or Pemetrexed or Docetaxel or Vinorelbine)
Arm b: placebo plus chemotherapy (Gemcitabine or Pemetrexed or Docetaxel or Vinorelbine)
Pembrol
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed diagnosis of advanced NSCLC, ineligible for surgery or definitive radiotherapy, will be enrolled in this study. (2) The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. (3) Advanced stage which is difficult to topical treatment. (4) Male/female participants who are at least 20 years of age on the day of signing informed consent. (5) Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. (6) Received one or two cytotoxic chemotherapy for advanced NSCLC including at least one platinum-doublet (example 1: patients with 1st line pemetrexed/cisplatin ? 2nd line docetaxel ? 3rd line pembrolizumab therapy can be enrolled, because they received two cytotoxic chemotherapy. Example 2: patients with 1st line weekly paclitaxel/carboplatin-based definitive concurrent chemoradiotherapy for stage III NSCLC? 2nd line pembrolizumab can be enrolled, because they received one platinum-based chemotherapy as the CCRT regimen for advanced NSCLC) (7) Has received prior therapy with an anti-PD-1, anti-PD-L1 agents (monotherapy) and progression to last PD-1/PD-L1 inhibitors. The last PD-1/PD-L1 inhibitor should be administered within 6 weeks before the study enrollment, and no other systemic therapy should be done between the interval. (8) At least one measurable lesion Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. (9) Available data for PD-L1 IHC results (any of one tested by 22C3, SP263, or SP142) irrespective of expression level. (10) EGFR and ALK wild type. In the case of squamous cell carcinoma participant, registration is possible after confirmation of negative EGFR. (11) Female participants: A WOCBP who has a negative urine pregnancy test within 72 hours prior to [randomization/allocation] (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. (12) Female participants: A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 180 days (a menstruation cycle) for study treatments with risk of genotoxicity] after the last dose of study treatment. (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.) (13) Male participants: A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period. (14) Participant who can comply with scheduled follow-up and toxicity control procedures. (15) Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment.
Exclusion criteria
Exclusion criteria: (1) Has received prior radiotherapy within 4 weeks of start of study treatment. (Except for the following cases, (a) Pallitive radiotherapy is allowed up to one week before the start of trial. (b) Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. (2) Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks . (3) Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. (4) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. (5) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. (6) Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, well differentiated thyroid carcinoma, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. (7) Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. Patients with oligo (<5) brain metastasis with size less than 1cm can be enrolled without prior radiotherapy, if the tumors are regarded as asymptomatic and stable, based on follow-up brain MRIs checked intervals of at least 3 months. However, all patients with previously non-irradiated brain metastases should have brain MRI checked within 4 weeks before starting administration of study drugs. (8) Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any PD-1/PD-L1 inhibitors. (9) Has active or previously documented autoimmune disease or inflammatory disease. (Inflammatory bowel disease [e.g. colitis or Crohn’s disease], diverticulitis [excluding diverticulum], systemic lupus erythematosus, sarcoidosis or Wegener’s granulomatosis [granulomatosis with multiple vasculitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis etc.] ). Exceptions to this criterion are: -Has a Vitiligo or alopecia -Has a hypothyroidism receiving stable hormone therapy. (e.g. after hashimoto syndrome) -Has a chronic skin disease that does not require systemic therapy. -Has a known history of celiac disease that controlled diet only. -Participant with no active disease within the past 5 years is incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy objective of this study is to evaluate the progression-free survival of pembrolizumab plus chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Overall survival, Response rate | — |
Countries
Korea, Republic of
Contacts
Public ContactJongMu Sun
Samsung Medical Center
Outcome results
None listed