RECRUITING

Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer

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Conditions

Platinum-Resistant Lung Small Cell CarcinomaPlatinum-Sensitive Lung Small Cell CarcinomaRecurrent Extensive Stage Lung Small Cell CarcinomaRefractory Extensive Stage Lung Small Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies the effects of durvalumab and lurbinectedin in treating patients with extensive stage small cell lung cancer that has come back (relapsed) or has not responded to previous treatment with chemotherapy and immunotherapy (refractory). Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Lurbinectedin is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving durvalumab and lurbinectedin may help kill more tumor cells and help patients live longer.

Official Title

Phase II Clinical Trial of Durvalumab (MEDI4736) and Lurbinectedin in Patients With Relapsed Extensive Stage Small Cell Lung Cancer Previously Treated With Chemotherapy and Immunotherapy

Quick Facts

Study Start:2020-12-04
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04607954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Histological or cytological confirmation of small cell lung cancer
  3. * Prior treatment requirements:
  4. * Relapsed or progressed after only one prior chemotherapy and PD-1 or PD-L1 inhibitor regimen
  5. * Prior therapy must have been an etoposide platinum doublet combined with PD-1 or PD-L1 inhibitor
  6. * Group 1: Must have "platinum-sensitive" disease according to the following definitions:
  7. * "Sensitive" disease: Relapse occurred \> 90 days after completion of prior therapy
  8. * "Resistant" Disease: Relapse occurred =\< 90 days after completion of prior therapy
  9. * Group 2: May have "platinum-sensitive" (Group 2A) or "platinumresistant" (Group 2B) disease
  10. * Measurable disease
  11. * Body weight \> 30 kg
  12. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  13. * Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration)
  14. * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 15 days prior to registration)
  15. * Platelet count \>= 100,000/mm\^3 (obtained =\< 15 days prior to registration)
  16. * Albumin \>= 2.5 mg/dL (obtained =\< 15 days prior to registration)
  17. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN if total bilirubin is \> 1.5 x ULN (obtained =\< 15 days prior to registration)
  18. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 15 days prior to registration)
  19. * Creatinine OR glomerular filtration rate (GFR) =\< 1.5 x ULN OR glomerular filtration rate (GFR) \> 60 mL/min for patients with creatinine \> 1.5 x ULN (obtained =\< 15 days prior to registration)
  20. * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
  21. * Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 120 days after last treatment
  22. * Life expectancy \>= 12 weeks
  23. * Provide written informed consent
  24. * Willingness to provide mandatory blood specimens for correlative research
  25. * Willingness to provide mandatory tissue specimens for correlative research
  26. * Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)
  1. * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  2. * Pregnant persons
  3. * Nursing persons
  4. * Persons of childbearing potential OR able to father a child who are unwilling to employ adequate contraception
  5. * Any of the following prior therapies:
  6. * Live vaccine \< 30 days prior to registration, including intranasal flu vaccine (e.g. Flu-Mist\[R\]) (Note: Injected seasonal influenza vaccine is not "live")
  7. * Surgery \< 28 days prior to registration
  8. * Chemotherapy or targeted small molecule therapy \< 21 days prior to registration
  9. * Radiation therapy \< 21 days prior to registration
  10. * Investigational therapy or investigational device \< 14 days prior to registration
  11. * Failure to recover to =\< grade 1 (or baseline) from adverse events due to previously administered therapies or prior surgery. Exceptions: Neuropathy, fatigue, and/or alopecia may be grade 1
  12. * Known active central nervous system (CNS) metastases. NOTE: Patients with previously treated brain metastases may participate provided all of the following are true:
  13. * They are stable (without evidence of progression by imaging =\< 4 weeks prior to registration and any neurologic symptoms have returned to baseline)
  14. * Have no evidence of new or enlarging brain metastases, and
  15. * Are not using steroids =\< 14 days prior to registration
  16. * Known leptomeningeal disease
  17. * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  18. * Known active human immunodeficiency virus (HIV) infection (defined as patients who are not on anti-retroviral treatment and have detectable viral load and CD4+ \< 500/ml). NOTE: HIV-positive patients who are well controlled on anti-retroviral therapy are allowed to enroll
  19. * Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. NOTE: Exceptions are allowed for:
  20. * Vitiligo
  21. * Resolved childhood asthma/atopy
  22. * Intermittent use of bronchodilators or inhaled steroids
  23. * Daily steroids at dose of =\< 10mg of prednisone (or equivalent)
  24. * Local steroid injections
  25. * Stable hypothyroidism on replacement therapy
  26. * Stable diabetes mellitus on non-insulin therapy
  27. * Sjogren's syndrome
  28. * Current or prior use of immunosuppressive medication \< 14 days prior to registration. The following are exceptions to this criterion:
  29. * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection)
  30. * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  31. * Steroids as premedication for hypersensitivity reactions (e.g., premedication for computed tomography \[CT\] scans)
  32. * Uncontrolled intercurrent illness including, but not limited to:
  33. * Ongoing or active infection requiring systemic therapy
  34. * Interstitial lung disease
  35. * Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others)
  36. * Known active hepatitis B (i.e., known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive)
  37. * Known active hepatitis C (i.e., positive for hepatitis C virus ribonucleic acid \[HCV RNA\] detected by polymerase chain reaction \[PCR\])
  38. * Known active tuberculosis (TB)
  39. * Symptomatic congestive heart failure
  40. * Unstable angina pectoris
  41. * Unstable cardiac arrhythmia or
  42. * Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse)
  43. * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  44. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  45. * Hypersensitivity to durvalumab or any of its excipients
  46. * Previous adverse event attributed to durvalumab or other PD-1 or PD-L1 directed therapy that led to drug discontinuation
  47. * History of grade \>= 3 immune-related adverse event or any grade of immune-related neurologic or ocular adverse event while receiving immunotherapy. Note: Patients who had endocrine adverse events =\< grade 2 are allowed to enroll if they are stable on appropriate replacement therapy and asymptomatic
  48. * Other active malignancy \< 6 months prior to registration. EXCEPTIONS: Non-melanotic skin cancer, papillary thyroid cancer, or carcinoma-in-situ of the cervix, or others curatively treated and now considered to be at less than 30% risk of relapse

Contacts and Locations

Principal Investigator

Konstantinos Leventakos, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Konstantinos Leventakos, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-04
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2020-12-04
Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Platinum-Resistant Lung Small Cell Carcinoma
  • Platinum-Sensitive Lung Small Cell Carcinoma
  • Recurrent Extensive Stage Lung Small Cell Carcinoma
  • Refractory Extensive Stage Lung Small Cell Carcinoma