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Clinical Trial 19936

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03137771

Phase: Phase II/III
Prinicipal Investigator: Bradford Perez

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Overview

Study Title

Maintenance Systemic Therapy versus Local Consolidative Therapy (Lct) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (Nsclc): A Randomized Phase II/III Trial

Summary

Objective

Primary Objectives 1.1.1 Phase II: To evaluate the impact of adding LCT (local consolidative therapy) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy 1.1.2 Phase III: To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy 1.2 Secondary Objectives (18-MAY-2018) 1.2.1 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure; 1.2.2 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions; 1.2.3 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity; 1.2.4 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage. 1.2.5 To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL) 1.2.6 To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA)

Treatments

Therapies

Medications

Alimta (Pemetrexed); Gemzar (gemcitabine); Pembrolizumab (Keytruda); Pemetrexed (); Taxotere (docetaxel); docetaxel (); gemcitabine ()

Inclusion Criteria

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trial and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child.
  • Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop limited metastases. Limited metastases is defined as 3 or fewer sites of metastatic disease.
  • Appropriate stage for study entry based on the following diagnostic workup: History/physical examination within 30 days prior to registration, Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least CT chest through the adrenals or PET/CT within 30 days prior to registration
  • Zubrod performance status 0, 1, or 2 within 30 days prior to registration
  • Adequate organ and bone marrow function per protocol.
  • HIV infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Negative serum pregnancy test within one week prior to registration for females of childbearing potential
  • Patients must have received first-line/induction chemotherapy comprising of immunotherapy and/or platinum based chemotherapy (at least 4 clcles or courses but less than 6) and achieved stable disease or a partial response. Though the intention is for every course/cycle to be identical in an induction regimen. Some but not all of the 4-5 cycles may omit an immunotherapy or platinum compound if the treating physician determines it is in the patients best interest secondary to toxicity or other institutional parameter.For patients treated with nivolumab, ipilimumab and 2 cycles of chemotherapy, the 4-5 cycles requirement will be met by 4-5 total doses of nivolumab. For patients treated with nivolumab and ipilimumab, this requirement will be met by 2 doses of ipilimumab and 4-5 doses of nivolumab.
  • Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage I-III NSCLC adjuvant or neo-adjuvant therapy for stage I-III NSCLC, as adjuvant therapy for previously resected or irradiated NSCLC, or for other previous cancers is permitted.
  • Radiotherapy for patients with brain metastases prior to registration is acceptable.
  • For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation; if the primary disease is found in the peripheral or central lung parenchyma without nodal disease for instance, SBRT may be employed; if primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation
  • If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy
  • The patient or a legally authorized representative must provide study-specific informed consent prior to registration.
  • Patients with brain metastases are eligible if these lesions have been previously treated or resolved and the patients have no clinical or radiographic evidence of progression prior to enrollment.
  • Other criteria apply

  • Exclusion Criteria

  • Clinical or radiologic evidence of untreated and/or progressive brain metastases
  • Cutaneous metastasis of NSCLC
  • Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions
  • Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
  • Metastases located within 3 cm of previously irradiated ( 40 Gy, Brachial plexus previously irradiated to > 50 Gy, Small intestine, large intestine, or stomach previously irradiated to > 45 Gy, , Brainstem previously irradiated to > 50 Gy, Lung previously irradiated with prior V20 Gy > 35%
  • Patients with NSCLC who have driver mutations for which targeted therapies (non-cytotoxic, non-immunotherapy based systemic therapy including but not limited to tyrosine-kinase inhibitors) are available. Such designations would include but not be limited to treatments targeting EGFR mutant or ALK positive NSCLC
  • If a patient has progressed in previous areas of primary disease that received definitive doses of radiation, these patients would require re-irradiation in previous high dose anatomic areas and are not eligible for this study
  • Patients with malignant pleural effusions that do not resolve after first-line systemic therapy; patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line chemotherapy
  • Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 SBRT plans to cover these distinct metastatic disease entities
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Patients who are pregnant or nursing
  • Participation in any investigational drug study for the treatment of cancer within 4 weeks prior to registration
  • For patients who received immunotherapy during induction, patients on chronic steroids or who have active autoimmune disease for which they received systemic treatment in the previous 2 years with corticosteroids, disease modifying agents, or immunosuppressive drugs are not eligible. Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is allowed. Patients with active interstitial lung disease or who have a history of pneumonitis for which they had received glucocorticoids are not eligible
  • Use of bevacizumab or other antiangiogenic therapy in first-line and planned maintenance therapy (due to potential for increased complications from local therapy).
  • Other criteria may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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