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Phase 2 N=30 Treatment

Neoadjuvant Pembrolizumab

Non-small Cell Lung Carcinoma

Enrolled (actual)
30
Serious AEs
20.0%
Results posted
Feb 2020
Primary outcome: Primary: Surgical Feasibility Rate as Measured by the Number of Subjects Who Undergo Surgery Following Neoadjuvant Pembrozulimab — 24 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Pembrolizumab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Neal Ready MD PhD
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Surgical Feasibility Rate as Measured by the Number of Subjects Who Undergo Surgery Following Neoadjuvant Pembrozulimab
24

Summary

This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a type of immunotherapy that may enhance the ability of the immune system to fight off cancer. The study will investigate the effects of pembrolizumab on the immune system and how certain immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab. Previous studies suggest that pembrolizumab could alter the immune cells in a way that the the immune cells identify cancer cells. Pembrolizumab has been approved for the treatment of advanced lung cancer, but is investigational in this setting.

Eligibility Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed NSCLC.
  • Clinical stage IB (>/= 3 cm per CT), Stage IIA/IIB, or Stage IIIA (N0-2) amenable to surgical resection.
  • Primary tumor >/= 3 cm (for all stages entered) to make it likely that excess tumor will be available after resection.
  • Patient must be deemed a surgical candidate.
  • ECOG performance status of 0 or 1 (Appendix C).
  • No prior chemotherapy, radiation therapy or biologic/targeted therapy for current diagnosis of lung cancer.
  • Adequate Organ Function
  • Age ≥18 years.
  • Non-pregnant. Females of child-bearing potential (not surgically sterilized or postmenopausal [a woman who is > 45 years of age and has not had menses for greater than 1 year]) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test.
  • No active invasive malignancy in the past 2 years other than non-melanoma skin cancer. Cancers that are in-situ are not considered invasive.
  • Signed written informed consent including HIPAA according to institutional guidelines.
  • Patients must agree to research blood sampling to participate in study.
  • Have measurable disease based on RECIST 1.1.
  • Post-op predicted FEV1 and DLCO > 40% predicted (or per institutional standard).

Exclusion Criteria

  • Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or used an investigational device within 4 weeks of the first dose of treatment.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Concurrent administration of any other anti-tumor therapy.
  • Has received prior therapy with an anti-PD-1, anti-PD-L-1, or anti-PD-L2 agent.
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Inability to comply with protocol or study procedures.
  • Active infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known additional invasive malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has had major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient o
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02818920). 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.

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