Stage IV non-small cell lung cancer
Conditions
Interventions
Group 2:Pembrolizumab
Group 1:MK-3475A
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8). Note: Mixed tumors will be characterized by the predominant cell type (squamous or nonsquamous); however, small cell elements are not permitted. 2.Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R] AND absence of ALK and ROS1 gene rearrangements). Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations is not required. Note: The presence of a KRAS mutation in a participant’s tumor is permitted. Note: Due to insufficient sensitivity, negative ctDNA results for EGFR, ALK, and ROS1 cannot be used to satisfy this inclusion criterion. 3.Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable (eligible for selection as target lesions) if progression has been shown in such lesions. 4.Has provided tumor tissue before randomization that demonstrates PD-L1 expression in >=50% of tumor cells (TPS >=50%) as assessed by IHC at a central laboratory. 5.An individual who is at least 18 years of age at the time of providing informed consent. 6.A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a POCBP OR Is a POCBP and: Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 120 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above; 7.The participant has provided documented informed consent for the study. Note: Participants who are legally blind, unable to read, or have a mild developmental or intellectual disability and can indicate a wish to participate in this study may enroll if the eligibility criteria are met, a legally acceptable representative provides consent on their behalf, and an impartial witness participates in the consent process. If eligible, these participants may be enrolled in this study to allow the possibility of benefit from the planned treatment(s). Note: References to a participant’s ‘legally acceptable representative’ for consenting purposes are not applicable for participants in the EEA. Participants in the EEA who are unable to provide documented informed consent because they are confirmed by the investigator to be legally blind, unable to read or write, and/or unable to sign due to a physical disability, but are able to indicate a willingness to participate, will be allowed to enroll in the study. Such parti; 8.Archival tumor tissue sample or newly obtained core,
Exclusion criteria
Exclusion criteria: 1.Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. 2.Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. 3.Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 4.Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. 5.Received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1week washout, is permitted. 6.Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention. 7.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Refer to Section 6.5 for information on COVID-19 vaccines; 8.Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. 9.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 intervention. 10.Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score =Grade 3) to study intervention and/or any of its excipients. 13.Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed. 14.History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 15.Active infection requiring systemic therapy. 16.History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. 17.Known psychiatric or subs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cycle1 AUC0-6 wks;Cycle3 AUC0-6 wks;; | — |
Countries
China
Contacts
Public ContactWang Mengzhao
Peking Union Medical College Hospital
Outcome results
None listed