Trial of Consolidation Pembrolizumab After Concurrent Chemotherapy and Proton Reirradiation for Thoracic Recurrences of Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Dec 18, 2026
  • participants needed
    41
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 25 February 2022
pembrolizumab
cancer chemotherapy
mk-3475
lung carcinoma

Summary

The main purpose of this study is to assess the safety, tolerability and anti-tumor activity of the experimental study drug pembrolizumab (also known as Keytruda or MK-3475) in people with non-small cell lung cancer (NSCLC) that has come back after radiation therapy.

Details
Condition Non-small Cell Lung Cancer
Treatment Pembrolizumab
Clinical Study IdentifierNCT03087760
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologic or cytologic diagnosis of NSCLC who have received previous intrathoracic radiation therapy with definitive intent and have a tumor recurrence in or near the prior irradiation fields. Re-biopsy of the recurrence is not required and is left to the discretion of the treating physician, although every effort should be made to confirm recurrence pathologically
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Age 18 or greater
Patients with prior invasive malignancies are allowed, provided they have been treated with definitive intent and have no evidence of active disease requiring treatment in the past 2 years
Patients must be capable of giving informed consent and be willing and able to comply with schedule
Serum total bilirubin 1.5 X upper limit of normal (ULN) OR Direct bilirubin ULN for subjects with total bilirubin levels > 1.5 ULN
Platelets >100,000 cells/mm3 and ANC > 1,250 cells/mm3
Creatinine 1.5 X ULN OR measured or calculated creatinine clearance 50 mL/min for subject with creatinine levels > 1.5 X institutional ULN. (GFR can also be used in place of creatinine or CrCl)
Clinical target volume (CTV) size must be <250 cc, no more than 74 Gy of prior radiation in 2 Gy fractions previously administered

Exclusion Criteria

Allergy to Pembrolizumab or related compounds
History of symptomatic CTCAEv4 grade 3 pneumonitis following the initial course of definitive radiation therapy
History of symptomatic idiopathic pulmonary fibrosis or interstitial lung disease
Use of continuous oxygen
Diagnosis of immunodeficiency or exposure to systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. (Nasal or oral inhalers are permissible)
Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome are not excluded from the study
History of allogenic tissue or solid organ transplant
Progression while on prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Patients with known extrathoracic metastases, including brain metastases, or known malignant pleural or pericardial effusion
Prior radiation treatment less than 6 months from the planned start of reirradiation of any part of the intended treatment volume
Pregnant or breast-feeding patients. Men and women of reproductive potential may not participate in this study unless they have agreed to use an effective contraceptive method while in this study
Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Known active Hepatitis B (e.g., HBsAg positive or HBV DNA detectable) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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