Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lurbinectedin — DRUG
  Given IV
• Palliative Radiation Therapy — RADIATION
  Undergo RT

Study Details

This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blocks a process called transcription that small cell lung cancer relies on to survive. It also damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Palliative radiotherapy is a routine medical treatment for patients who have lung cancer that has spread to other parts of the body (metastatic), and is used to relieve symptoms caused by cancer or to patients from developing symptoms. This trial may help doctors understand if treating patients with lurbinectedin and palliative radiotherapy at the same time would make them both work better than either one alone or if they could cause more side effects for patients when given together.

Key Dates

Start date

Jul 27, 2022

Status verified

Oct 2025

Primary completion

Jul 28, 2026

Completion

Jul 28, 2027

Study Design

Enrollment

22 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (lurbinectedin and palliative radiation therapy)
  Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin IV over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin [ Time Frame: Up to 1 year ]

Central Contacts

• Kristin Higgins, MD
  404.778.3473
  [email protected]

Locations (3)

Find similar trials in Atlanta, GA

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