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Phase 3 Completed N=125 Randomized Triple-blind Treatment

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)-China Extension Study

Source: ClinicalTrials.gov NCT03875092 ↗
Enrolled (actual)
125
Serious AEs
39.6%
Results posted
Oct 2021
Primary outcomePrimary: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) — 8.3; 4.2 Months
◆ Published Evidence
Established
51citations · ~10 / year
Pembrolizumab Plus Chemotherapy for Chinese Patients With Metastatic Squamous NSCLC in KEYNOTE-407.
JTO clinical and research reports · 2021 · Open access · High-confidence link

Summary

In this China extension study, carboplatin and paclitaxel with or without pembrolizumab (MK-3475, KEYTRUDA®) will be administered to Chinese adults with first line metastatic squamous non-small cell lung cancer (NSCLC). The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival (OS) in Chinese participants. After analysis of interim results was conducted, the protocol was amended (Amendment 5) to allow participants the option to discontinue placebo in the control arm and to switch to pembrolizumab in the event of documented progressive disease as assessed by central review.

Linked Publications (3)

  • Pembrolizumab Plus Chemotherapy for Chinese Patients With Metastatic Squamous NSCLC in KEYNOTE-407.
    JTO clinical and research reports · 2021 · 51 citations · Open access · High-confidence link
  • Pembrolizumab Plus Chemotherapy for Metastatic NSCLC With Programmed Cell Death Ligand 1 Tumor Proportion Score Less Than 1%: Pooled Analysis of Outcomes After Five Years of Follow-Up.
    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2024 · 36 citations · Open access · Likely link
  • Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia.
    Immunotherapy · 2023 · 10 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
8.3; 4.2
PRIMARY
Overall Survival (OS)
30.1; 12.7
SECONDARY
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
80.0; 43.3
SECONDARY
Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
7.1; 3.5
SECONDARY
Number of Participants Who Experienced an Adverse Event (AE)
65; 60
SECONDARY
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
8; 4

Eligibility Criteria

Inclusion Criteria

  • Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer [AJCC]) squamous NSCLC.
  • Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
  • Has not received prior systemic treatment for metastatic NSCLC.
  • Has provided tumor tissue from locations not radiated prior to biopsy.
  • Has a life expectancy of at least 3 months.
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • Has adequate organ function.
  • If female of childbearing potential, is willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study treatment.
  • If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study treatment through 95 days after the last dose of study treatment. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.

Exclusion Criteria

  • Has non-squamous histology NSCLC.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of pembrolizumab.
  • Before the first dose of study drug: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease; b) Has received other targeted or biological antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic disease; c) Has had major surgery ( 30 Gray (Gy) within 6 months of the first dose of study treatment.
  • Completed palliative radiotherapy within 7 days of the first dose of study treatment.
  • Is expected to require any other form of antineoplastic therapy while on study.
  • Has received a live-virus vaccination within 30 days of planned treatment start.
  • Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has pre-existing peripheral neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) Version 4 criteria.
  • Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody.
  • Has a known sensitivity to any component of carboplatin or paclitaxel or nab-paclitaxel.
  • Has active autoimmune disease that has required systemic treatment in past 2 years.
  • Is on chronic systemic steroids.
  • Had prior treatment with any other anti-programmed cell death 1 (anti-PD-1), or programmed cell death ligand 1 (PD-L1) or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms.
  • Has participated in any other pembrolizumab trial and has been treated with pembrolizumab.
  • Has an active infection requiring therapy.
  • Has known history of Human Immunodeficiency Virus (HIV).
  • Has known active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
  • Is, at the time of providing documented informed consent, a regular user (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol).
  • Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03875092) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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