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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Lurbinectedin — DRUG
  Given IV

Study Details

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 Dates

Start date

Dec 4, 2020

Status verified

Mar 2026

Primary completion

Sep 1, 2026

Completion

May 1, 2031

Study Design

Enrollment

29 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A (platinum sensitive; progression >3 months)
  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.
• Experimental: Group B (platinum refractory; progression >= 3 months)
  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.

Primary Outcome Measure

6-month progression-free survival rate [ Time Frame: At 6 months ]

Locations (1)

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