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

NCT04607954 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MC192320-001531
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival rate

  The proportion of successes for 6-month PFS rate will be estimated by the number of successes divided by the total number of evaluable patients. Ninety percent confidence intervals for the true success proportion will be calculated according to the exact binomial method.

  At 6 months

Secondary Outcomes (4)

• Response rate

  Up to 5 years

• Progression-free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Incidence of adverse events (AEs)

  Up to 30 days post treatment

Study Arms (2)

Group A (platinum sensitive; progression >3 months)

EXPERIMENTAL

Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: Durvalumab; Drug: Lurbinectedin

Group B (platinum refractory; progression >= 3 months)

EXPERIMENTAL

Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: Durvalumab; Drug: Lurbinectedin

Interventions

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

Group A (platinum sensitive; progression >3 months); Group B (platinum refractory; progression >= 3 months)

Lurbinectedin DRUG

Given IV

Also known as: PM01183, Zepzelca

Group A (platinum sensitive; progression >3 months); Group B (platinum refractory; progression >= 3 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

durvalumab; Immunoglobulin G; Disulfides; PM 01183

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Konstantinos Leventakos, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Anastasios Dimou, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: October 29, 2020
• Study Start: December 4, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2031
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)