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NCT02879994

Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer

Completed Phase 2 Results posted Last updated 14 July 2021
What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Stage IIIA Non-Small Cell Lung Cancer in 11 participants. Completed in 3 January 2019.

Timeline
15 September 2016
Primary endpoint
30 November 2017
3 January 2019

Quick facts

Lead sponsorJonsson Comprehensive Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment11
Start date15 September 2016
Primary completion30 November 2017
Estimated completion3 January 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Stage IIIA Non-Small Cell Lung Cancer or Stage IIIB Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) Determined as the Percentage of Patients Achieving Complete Response or Partial Response as Respectively Defined in RECIST 1.1 Primary · Up to 14 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by accessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

GroupValue95% CI
Treatment (Pembrolizumab)1
Number of Participants With Adverse Events According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Secondary · Up to 14 Months

Number of Participants with Adverse Events According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

GroupValue95% CI
Treatment (Pembrolizumab)11
Efficacy (Progression Free Survival (PFS) and Overall Survival (OS)) Assessed by RECIST 1.1 Secondary · assessed for up to 14 months

Will evaluate Progression Free Survival and Overall Survival. Average of Progression Free Survival recorded for limited number of subjects analyzed. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Progression free survival
GroupValue95% CI
Treatment (Pembrolizumab)11942 – 123

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Pembrolizumab)
Serious: 6/11 (55%)
Deaths: 2/11

Serious adverse events (6 terms)

ReactionSystemTreatment (Pembrolizumab)
Respiratory failureRespiratory, thoracic and mediastinal disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
HypotensionMetabolism and nutrition disorders
HypercalcemiaBlood and lymphatic system disorders
Back PainMusculoskeletal and connective tissue disorders
Elevated alanine aminotransferaseHepatobiliary disorders
Other adverse events (12 terms — click to expand)

ReactionSystemTreatment (Pembrolizumab)
RashSkin and subcutaneous tissue disorders
PruritusSkin and subcutaneous tissue disorders
DiarrheaGastrointestinal disorders
Flu-like symptomsGeneral disorders
Adrenal insufficiencyEndocrine disorders
ChillsGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
HyperglycemiaGastrointestinal disorders
AnorexiaPsychiatric disorders
Alanine aminotransferase increasedBlood and lymphatic system disorders
Aspartate aminotransferase increasedBlood and lymphatic system disorders
Thyroid-stimulating hormone decreasedBlood and lymphatic system disorders

Most-reported serious reactions: Respiratory failure, Pneumonitis, Hypotension, Hypercalcemia, Back Pain, Elevated alanine aminotransferase.

Data from ClinicalTrials.gov NCT02879994 adverse events section.

Sponsor's own description

This phase II trial studies how well pembrolizumab works in treating patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may block growth in different ways by targeting certain cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Phase II Study of Pembrolizumab in EGFR-Mutant, PD-L1+, Tyrosine Kinase Inhibitor Naïve Patients With Advanced NSCLC.
    Lisberg A, Cummings A, Goldman JW, Bornazyan K, et al · · 2018 · cited 477× · PMID 29874546 · DOI 10.1016/j.jtho.2018.03.035
  2. IL6 Mediates Suppression of T- and NK-cell Function in EMT-associated TKI-resistant EGFR-mutant NSCLC.
    Patel SA, Nilsson MB, Yang Y, Le X, et al · · 2023 · cited 83× · PMID 36595561 · DOI 10.1158/1078-0432.ccr-22-3379
  3. The progress and challenge of anti-PD-1/PD-L1 immunotherapy in treating non-small cell lung cancer.
    Qu J, Mei Q, Liu L, Cheng T, et al · · 2021 · cited 62× · PMID 33643442 · DOI 10.1177/1758835921992968
  4. Molecular markers and prediction of response to immunotherapy in non-small cell lung cancer, an update.
    Blons H, Garinet S, Laurent-Puig P, Oudart JB. · · 2019 · cited 49× · PMID 30775025 · DOI 10.21037/jtd.2018.12.48
  5. Tumour Microenvironment and Immune Evasion in EGFR Addicted NSCLC: Hurdles and Possibilities.
    Santaniello A, Napolitano F, Servetto A, De Placido P, et al · · 2019 · cited 46× · PMID 31554160 · DOI 10.3390/cancers11101419
  6. A Review About Pembrolizumab in First-Line Treatment of Advanced NSCLC: Focus on KEYNOTE Studies.
    Qu J, Wang L, Jiang M, Zhao D, et al · · 2020 · cited 33× · PMID 32801888 · DOI 10.2147/cmar.s257188
  7. Efficacy of immunotherapy in oncogene-driven non-small-cell lung cancer.
    Vokes NI, Pan K, Le X. · · 2023 · cited 28× · PMID 36950275 · DOI 10.1177/17588359231161409
  8. Immunotherapy for EGFR-mutant advanced non-small-cell lung cancer: Current status, possible mechanisms and application prospects.
    Shi C, Wang Y, Xue J, Zhou X. · · 2022 · cited 27× · PMID 35935943 · DOI 10.3389/fimmu.2022.940288

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Stage IIIA Non-Small Cell Lung Cancer

Currently open trials in the same condition.

Other Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

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