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    Association details:
    Biomarker:PD-L1 expression
    Cancer:Lung Non-Squamous Non-Small Cell Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    02/16/2021
    Excerpt:
    Targeted therapy or immunotherapy for advanced or metastatic disease...PD-L1≥1%...first-line therapy...(carboplatin or cisplatin)/pemetrexed/ pembrolizumab (nonsquamous)
    Secondary therapy:
    carboplatin + pemetrexed; cisplatin + pemetrexed
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Excerpt:
    Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non–Small Cell Lung Cancer

    Excerpt:
    ...Members of all genders, races, and ethnic groups are eligible for this study.Participants must meet all the following inclusion criteria to be eligible for participation in this study (no waivers for participant eligibility will be permitted).1)Participants assigned male at birth and participants assigned female at birth, 18 years of age or older, able to understand and give writteninformed consent.2)Life expectancy ≥ 3 months.3)Pathologically documented NSCLC that meets both criteria below:a)Have documented evidence of Stage IV NSCLC disease at the time ofenrollment (based on AJCC, Eighth Edition).b)Have documented negative test results for EGFR and ALK mutations.Note: tumor testing for EGFR or ALK mutations is required for participants with nonsquamous NSCLC tumor histology if status isunknown4)Have no actionable genomic alterations such as ROS proto-oncogene1, neurotrophic tyrosine receptor kinase, proto-oncogene B-raf, RETmutations, or other driver oncogenes with approved frontline therapies.Testing of actionable genomic alterations required by local regulationswill be performed locally.5)Provide adequate tumor tissue from locations not radiated prior to biopsy to evaluate PD-L1 expression prior to randomization.6)Have not received prior systemic treatment for metastatic NSCLC.Participants who received chemotherapy for nonmetastatic disease areeligible if the treatment was completed at least 12 months prior to the start of study treatment.7)Measurable disease per RECIST v1.1 criteria by investigator assessment.8)ECOG performance status score of 0 or 1.9)Organ function requirement.10)Participants assigned male at birth and participants assigned femaleat birth of childbearing potential who engage in heterosexual intercoursemust agree to use protocol-specified method(s) of contraception fromscreening visit until 6 months after the last dose of chemotherapy and120 days after the last dose of DOM, ZIM, or PEMBRO (or longer according to local regulatory requirements).11)Willing and able to comply with the requirements and restrictions in this protocol.`...
    Trial ID:
    2022-000578-25
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Pembrolizumab (MK-3475) in elderly patients with non-small cell lung cancer Estudio con el fármaco Pembrolizumab en pacientes ancianos con cancer de pulmón

    Excerpt:
    ...- Patients with histologically or cytological documented stage IIIB or IV squamous and non-squamous non-small-cell lung cancer previously untreated.- EGFR and ALK have to be wild-type.- The subject must be willing and able to provide written informed consent/assent for the trial.- Patients must be aged >70 years, on day of signing informed consent.- PD-L1 expression ≥ 1%- ECOG 0 - 1- Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. ...
    Trial ID:
    2016-004353-32
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A trial comparing the pembrolizumab platinum based chemotherapy combination with pembrolizumab monotherapy in first line treatment of non small-cell lung cancer (NSCLC) patients Etude comparant l'association chimiothérapie à base de sels de platine et pembrolizumab au pembrolizumab en monothérapie, en première ligne de traitement de cancers broncho-pulmonaires non à petites cellules (CBPNC)

    Excerpt:
    ...PD L1 expression on ≥50 % of tumor cells, which will be determined locally*.6. ...
    Trial ID:
    2020-002626-86
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    PULSE: Pembrolizumab en maintenance à dose conventionnelle ou adaptée dans le cancer bronchique non à petites cellules : une étude de non infériorité

    Excerpt:
    ...Evaluate the target saturation and engagement in both arms.Exploratory objective:PFS, OS according to PD-L1 expression.PFS, OS according to dynamic evolution of circulating tumor DNA.PFS, OS according to the occurrence of antidrug-antibodies (ADA).PFS, OS according to the Lung Immune Prognostic Index (LIPI)-score.PFS, OS according to the administration or not of pemetrexed...
    Trial ID:
    2021-006795-16
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

    Excerpt:
    ...- Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells....
    Trial ID:
    EA5163
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC

    Excerpt:
    ...MPR in eligible stage IIA-IIIB (N2) NSCLC participants (AJCC Version 8, no known sensitizing EGFR or ALK alterations) following neoadjuvant pembrolizumab plus chemotherapy`Event-free survival (EFS)`Number of Participants with One or More Adverse Events`PD-L1 expression and status of pre-treatment tumor sample...
    Trial ID:
    NCT05894889
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer

    Excerpt:
    ...PD L1 expression is...
    Trial ID:
    NCT02955758
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

    Excerpt:
    ...Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1%`Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC...
    Trial ID:
    KEYMAKER-U01
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)

    Excerpt:
    ...- PD-L1 positive tumor...
    Trial ID:
    KEYNOTE-042
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)-China Extension Study

    Excerpt:
    ...- PD-L1 positive tumor...
    Trial ID:
    Keynote 042 China Extension
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Pembrolizumab in Elderly Patients With Advanced Lung Cancer

    Excerpt:
    ...PD-L1 expression ≥ 1% 8....
    Trial ID:
    NCT03293680
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)

    Excerpt:
    ...- PD-L1 strong expressing tumor as determined by immunohistochemistry (IHC) at a central laboratory...
    Trial ID:
    KEYNOTE-024
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %

    Excerpt:
    ...PD-L1 expression on ≥ 50 % of tumor cells, which will be determined locally....
    Trial ID:
    PERSEE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Phase II randomized, open, controlled trial for PD-1 monoclonal antibody combined with platinum-containing chemotherapy versus PD-1 monoclonal antibody for first-line treatment of recurrent or advanced metastatic non-small cell lung cancer with positive PD-L1 expression

    Excerpt:
    ...Patients with positive EXPRESSION of PD-L1 (TPS>=1%) who were provided with detectable tissue samples before enrollment and confirmed by the central laboratory; 6. ...
    Trial ID:
    ChiCTR2000036782
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    First-line pembrolizumab plus platinum-pemetrexed in metastatic non-small cell lung cancer: Clinical experience in a Spanish tertiary hospital.

    Published date:
    05/25/2023
    Excerpt:
    We have done a descriptive, retrospective, single center study developed in a Spanish tertiary hospital where patients with metastatic nonsquamous NSCLC treated with first-line pembro plus platinum-pem have been included....Stratified by PD-L1 expression, mOS was 9 months (6.3 -11.7) in PD-L1 < 1%; 25 months in PD-L1 1-49%, NR in the rest. Median PFS was 9 months (5.8-12.2). According to PD-L1 expression, mPFS was 6 months (4.6 - 7.4) in PD-L1 < 1%; 19 months (8.7 - 29.2) PD-L1 1-49% and 7 months (0.6 - 13.4) in PD-L1 50%.
    Secondary therapy:
    Chemotherapy + pemetrexed
    DOI:
    10.1200/JCO.2023.41.16_suppl.e21142