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

Not Recruiting

Trial ID: NCT02955758


This phase II trial studies how well pembrolizumab works in treating patients with non-squamous non-small cell lung cancer which has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Official Title

A Phase 2 Trial of Pembrolizumab in Metastatic Non-squamous NSCLC Examining Circulating Tumor DNA Levels as a Surrogate Biomarker of Response

Stanford Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology


Inclusion Criteria:

   1. Has a pathologically proven recurrent or metastatic non squamous non small cell lung

   2. (a) Previously received at least one line of prior systemic therapy for metastatic

   i. If the patient has a sensitizing EGFR mutation or ALK rearrangement, the patient
   must have received at least one prior targeted therapy for metastatic disease (ie,
   EGFR TKI therapy or ALK TKI therapy, respectively).

   ii. There is no limit on prior therapies allowed. Patients must have completed
   previous treatment (including other investigational therapy) in greater than or equal
   to the following times prior to initiation of trial treatment:

      1. Anti cancer monoclonal antibody (mAb) therapy must be completed ≥ 3 weeks prior
      to trial treatment

      2. Chemotherapy administered in a daily or weekly schedule must be completed ≥ 1
      week prior to trial treatment

      3. Chemotherapy administered in an every 2 week schedule must be completed ≥ 2 weeks
      prior to trial treatment

      4. Chemotherapy administered in an every 3 week schedule must be completed ≥ 3 weeks
      prior to trial treatment

      5. Targeted small molecule therapy must be completed ≥ 1 week prior to trial
      treatment OR (b) Have not received prior systemic therapy for their cancer in
      recurrent or metastatic setting, AND have a tumor with Tumor Proportion Score
      (TPS) ≥ 50% as measured by 22C3 PD L1 IHC test, AND no evidence of a sensitizing
      EGFR mutation or ALK rearrangement.

   3. Prior radiation therapy allowed as long as completed in the following times prior to
   initiation of trial treatment:

      1. Definitive curative intent radiation ≥ 3 weeks prior to trial treatment

      2. Palliative body radiation ≥ 1 week prior to trial treatment

      3. Stereotactic brain radiation ≥ 1 week prior to trial treatment

      4. Whole brain radiation ≥ 2 weeks prior to trial treatment

   4. Patients with previously treated (with radiation or surgery) brain metastases that are
   stable are allowed. Patients with stable or progressing metastases must have
   metastases ≤ 1.5 cm, be asymptomatic, and either not be on steroids or be on 10 mg
   prednisone equivalent or less.

   5. Has measurable disease based on RECIST v1.1 criteria

   6. Is medically able and willing to undergo needle biopsy of a tumor lesion. PD L1
   expression is not required to enroll in the trial.

   7. Has life expectancy ≥ 3 months

   8. Ability to understand and the willingness to sign a written informed consent document.

   9. ≥ 18 years of age on day of signing informed consent

10. ECOG performance status of 0 or 1 (Appendix A)

11. Adequate organ function:

      1. Absolute neutrophil count (ANC) ≥ 1,000/mcL

      2. Platelets ≥ 75,000/mcL

      3. Hemoglobin ≥ 8 g/dL

      4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated
      creatinine clearance ≥ 50 mL/min for patient with creatinine levels > 1.5 x
      institutional ULN

      5. Serum total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ ULN for patients with
      total bilirubin levels > 1.5 ULN

      6. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN OR ≤ 5 x ULN for patients with liver

12. Female patients of childbearing potential must have a negative urine or serum
   pregnancy test prior to the first dose of trial treatment. They must also agree to two
   barrier methods or a barrier method plus a hormonal method, or agree to abstain from
   heterosexual activity, for the course of the study through 120 days after the last
   dose of trial treatment. Females who have been surgically sterilized or are free from
   menses for > 1 year (postmenopausal) may enroll.

13. Male patients with a female partner of childbearing potential should agree to use a
   barrier method of contraception, or agree to abstain from heterosexual activity for
   the course of the study through 120 days after the last dose of trial treatment.

Exclusion Criteria:

   1. Is currently receiving another investigational therapy

   2. Has received prior anti PD 1 or anti PD L1 therapy

   3. Has clinically significant toxicities from previous anti cancer therapy that have not
   resolved, or have not stabilized at a new baseline

   4. Has undergone a surgical procedure involving general anesthesia within 2 weeks of
   starting trial treatment, or has inadequate healing or recovery from complications of
   surgery prior to starting trial treatment. This does not apply to low risk procedures
   such as thoracentesis; paracentesis; chest tube/PleurX catheter placement; line
   placement; needle biopsy of tumor; and bronchoscopy.

   5. Is receiving high dose systemic steroid therapy within 3 days of trial treatment.
   Topical and intraarticular steroid injections are allowed, as are physiologic doses of
   systemic steroids (≤ 10 mg of prednisone equivalent daily).

   6. Has carcinomatous meningitis as determined by positive CSF cytology

   7. Has known active additional malignancy that is undergoing active treatment.

   8. Has active autoimmune disease that has required systemic treatment in the past 2 years
   (ie, with use of disease modifying agents, supra physiologic doses of systemic
   corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine,
   insulin; or physiologic corticosteroid replacement therapy for adrenal or pituitary
   insufficiency, etc.) is not considered a form of systemic treatment. Asthma; type I
   diabetes mellitus; hypothyroidism; and vitiligo are allowed.

   9. Has a history or current evidence of any condition, therapy, or laboratory abnormality
   that might confound the results of the trial, interfere with the patient's
   participation for the full duration of the trial, or is not in the best interest of
   the patient to participate, in the opinion of the treating investigator. This includes
   known active tuberculosis; Grade 3 active infection; history of allogeneic bone marrow
   transplant or solid organ transplant; known history of Human Immunodeficiency Virus
   (HIV); known active Hepatitis B (eg, Hep B DNA positive in prior 3 months) or known
   active Hepatitis C (eg, HCV RNA [qualitative] is detected in prior 3 months).

10. Known active interstitial lung disease, or current (non infectious) pneumonitis or
   history of (non infectious) pneumonitis that required oral steroids.

11. Is pregnant or breastfeeding, or expecting to conceive or father children within the
   projected duration of the trial, starting


biological: Pembrolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Brianna Velazquez

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