NCT04607954

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

MC1923 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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate whether the combination of durvalumab with lurbinectedin can increase the 6-month progression-free survival in patients with extensive stage small cell lung cancer who have progressed after initial combination of chemotherapy and immunotherapy. (Group A and B) SECONDARY OBJECTIVES: I. To describe the safety and adverse event profile of each treatment group in patients with extensive stage small cell lung cancer who have progressed after initial combination of chemotherapy and immunotherapy. II. To assess in a preliminary fashion antitumor efficacy of this approach by assessing overall survival, progression-free survival, and response rate for each treatment group. CORRELATIVE RESEARCH OBJECTIVE: I. Blood and tissue will be banked for future studies. OUTLINE: 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. After completion of study treatment, patients without disease progression are followed up at 30 days, every 6 weeks until disease progression, and then every 3 months thereafter for up to 5 years from enrollment. After completion of study treatment, patients with disease progression are followed every 3 months for up to 5 years from enrollment.

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

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
DRUG	Lurbinectedin	Given IV

Timeline

• Start date: 2020-12-04
• Primary completion: 2026-09-01
• Completion: 2031-05-01
• First posted: 2020-10-29
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study