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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04607954

Run by

Mayo Clinic

People needed

29

Starts

2020-12-04

Expected to finish

2031-05-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years
• Histological or cytological confirmation of small cell lung cancer
• Prior treatment requirements:
• Relapsed or progressed after only one prior chemotherapy and PD-1 or PD-L1 inhibitor regimen
• Prior therapy must have been an etoposide platinum doublet combined with PD-1 or PD-L1 inhibitor
• Group 1: Must have "platinum-sensitive" disease according to the following definitions:
• "Sensitive" disease: Relapse occurred > 90 days after completion of prior therapy
• "Resistant" Disease: Relapse occurred =< 90 days after completion of prior therapy
• Group 2: May have "platinum sensitive" (Group 2A) or "platinum resistant" (Group 2B) disease
• Measurable disease
• Body weight > 30 kg
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Hemoglobin >= 9.0 g/dL (obtained =< 15 days prior to registration)
• Absolute neutrophil count (ANC) >= 1500/mm\^3 (obtained =< 15 days prior to registration)
• Platelet count >= 100,000/mm\^3 (obtained =< 15 days prior to registration)
• Albumin >= 2.5 mg/dL (obtained =< 15 days prior to registration)
• 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)
• 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)
• 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)
• Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
• 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
• Life expectancy >= 12 weeks
• Provide written informed consent
• Willingness to provide mandatory blood specimens for correlative research
• Willingness to provide mandatory tissue specimens for correlative research

You may not qualify if…

• 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:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential OR able to father a child who are unwilling to employ adequate contraception
• Any of the following prior therapies:
• Live vaccine < 30 days prior to registration, including intranasal flu vaccine (e.g. Flu-Mist[R]) (Note: Injected seasonal influenza vaccine is not "live")
• Surgery < 28 days prior to registration
• Chemotherapy or targeted small molecule therapy < 21 days prior to registration
• Radiation therapy < 21 days prior to registration
• Investigational therapy or investigational device < 14 days prior to registration
• 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
• Known active central nervous system (CNS) metastases. NOTE: Patients with previously treated brain metastases may participate provided all of the following are true:
• They are stable (without evidence of progression by imaging =< 4 weeks prior to registration and any neurologic symptoms have returned to baseline)
• Have no evidence of new or enlarging brain metastases, and
• Are not using steroids =< 14 days prior to registration
• Known leptomeningeal disease
• 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
• 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
• 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:
• Vitiligo
• Resolved childhood asthma/atopy
• Intermittent use of bronchodilators or inhaled steroids
• Daily steroids at dose of =< 10mg of prednisone (or equivalent)
• Local steroid injections
• Stable hypothyroidism on replacement therapy

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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