What Is Lurbinectedin?
Lurbinectedin is an FDA-approved medication for small cell lung cancer. It works by selectively inhibiting oncogenic transcription. This means it targets and interferes with the process by which cancer cells create new proteins and grow, ultimately aiming to stop their proliferation. This action helps to control the growth and spread of cancer cells. While approved for small cell lung cancer, lurbinectedin is also being investigated in clinical trials for other advanced cancers. These include advanced solid tumors, relapsed small cell lung cancer, extensive-stage small-cell lung cancer, advanced soft-tissue sarcoma, and ovarian cancer. The drug is administered by intravenous (IV) infusion, typically once every 21 days, until disease progression or unacceptable toxicity occurs. Clinical trials involving lurbinectedin have enrolled a total of 7,566 participants across 54 trials. Of these, 15 trials are currently recruiting new participants, while 17 trials have been completed. The earliest trial began in 2013, with ongoing research projected until 2026.
Uses and Conditions Under Study
Lurbinectedin is primarily studied for various types of cancer, with a significant focus on lung cancers and other advanced solid tumors.
- Small Cell Lung Cancer (SCLC): This aggressive form of lung cancer is a major area of research for lurbinectedin. It is being investigated for small cell lung cancer, relapsed small cell lung cancer, extensive-stage small-cell lung cancer, and small cell lung carcinoma. The drug's mechanism of inhibiting oncogenic transcription is thought to be beneficial in controlling the rapid growth characteristic of SCLC. Across all these related conditions, lurbinectedin is being studied in a total of 20 trials.
- Advanced Solid Tumors: Beyond lung cancer, lurbinectedin is also under investigation for a broad range of advanced solid tumors. These are cancers that have spread from their original site and may be difficult to treat with standard therapies. The drug's ability to interfere with cancer cell growth makes it a candidate for these challenging cases. There are 9 trials exploring lurbinectedin's effectiveness in advanced solid tumors.
- Other Cancers: Lurbinectedin is also being explored for other specific cancer types. This includes advanced soft-tissue sarcoma, a rare cancer that develops in the soft tissues of the body, and ovarian cancer, a cancer that begins in the ovaries. Each of these conditions is being studied in 2 trials, aiming to determine if lurbinectedin can offer new treatment options.
Dosing
Lurbinectedin is administered as an intravenous (IV) infusion. This means the medication is delivered directly into a vein, typically in a hospital or clinic setting. The standard administration schedule involves receiving the infusion once every 21 days. Treatment continues until the disease progresses or unacceptable side effects occur.
In clinical trials, different doses of lurbinectedin have been studied. Common doses include 3.2 mg/m2 or 2.6 mg/m2. The initial starting dose in some studies is 3.2 mg/m2. The specific dose and schedule may vary depending on the patient's condition, other treatments being received, and individual tolerance to the medication. For example, some trials explore lurbinectedin in combination with other agents like doxorubicin, irinotecan, or immunotherapy drugs such as avelumab or durvalumab, which might influence the dosing strategy. The exact dosage for a patient will be determined by their healthcare provider based on their specific medical needs and treatment plan.
Side Effects
Information regarding specific side effects and their frequencies for Lurbinectedin was not available in the provided clinical trial data.
Clinical Trial Results
Clinical trials have investigated Lurbinectedin (PM01183) both alone and in combination with other therapies across various advanced solid tumors.
Small Cell Lung Cancer (SCLC)
In a study (NCT02454972) involving patients with advanced solid tumors, including SCLC, treatment with Lurbinectedin alone showed an Overall Response Rate (ORR) of **36.2%** in the SCLC cohort. For these patients, the median duration of response was 5.3 months, median progression-free survival was 3.7 months, and median overall survival was 8.1 months.
Another study (NCT01970540) evaluated Lurbinectedin in combination with doxorubicin in patients with advanced unresectable solid tumors. For patients with SCLC in the second-line setting, the median duration of response was 5.2 months. The median overall survival was 7.9 months, and median progression-free survival was 3.3 months.
Non-Small Cell Lung Cancer (NSCLC)
Currently Recruiting Trials
Lurbinectedin is currently being investigated in numerous clinical trials, exploring its potential as a treatment for various cancers, often in combination with other therapies. These studies aim to understand its effectiveness and safety for patients.
A Phase 1/2 study, NCT06681220, sponsored by the VA Office of Research and Development, is enrolling up to 166 patients with relapsed Small Cell Lung Cancer. This trial evaluates Stenoparib plus Temozolomide, with different dosage arms including a study drug combination, standard of care, and a biomarker-negative standard of care.
AbbVie is sponsoring a Phase 2 study, NCT07155174, recruiting 180 participants with previously untreated extensive stage Small Cell Lung Cancer. This trial assesses the optimal dose, adverse events, and disease activity change of intravenous ABBV-706 in combination with Atezolizumab versus standard of care.
For patients with advanced Desmoplastic Small Round Cell Tumor (DSRCT), the Italian Sarcoma Group is conducting a Phase 2 study, NCT07328425, targeting 20 patients. It investigates Lurbinectedin in combination with Irinotecan.
The National Cancer Center, Korea, is running a Phase 2 study, NCT07121478, for 46 patients with high-grade Pancreatic Neuroendocrine Tumors, using a single-arm dosage.
Luye Pharma Group Ltd. is sponsoring a large Phase 3 trial, NCT06496048, with an enrollment goal of 180 patients with relapsed SCLC. This study compares Lurbinectedin monotherapy or Lurbinectedin plus Irinotecan combined therapy against Topotecan.
The National Cancer Institute (NCI) is investigating Lurbinectedin with or without Avelumab in Small Cell Carcinoma of the Bladder and High Grade Neuroendocrine Tumors of the Urinary Tract in a Phase 2 study, NCT06228066, enrolling 45 participants.
Daiichi Sankyo's Phase 3 study, NCT06203210, aims to enroll 540 subjects with relapsed Small Cell Lung Cancer, comparing Ifinatamab Deruxtecan against a physician's choice of treatment.
PharmaMar is sponsoring a Phase 3 study, NCT06088290, for 450 participants with metastatic Leiomyosarcoma. This trial evaluates Lurbinectedin in combination with Doxorubicin versus Doxorubicin alone as a first-line treatment.
Children's Hospital of Philadelphia is conducting a Phase 1/2 study, NCT05918640, for 63 patients with FET-Fused Tumors, including Ewing Sarcoma, Desmoplastic Small Round Cell Tumor, and Undifferentiated Sarcoma, to assess Lurbinectedin's safety and effectiveness.
M.D. Anderson Cancer Center's Phase 1 study, NCT05636111, is enrolling 34 patients with platinum-resistant Ovarian Cancer to evaluate Lurbinectedin in combination with weekly Paclitaxel and Bevacizumab.
ERLINDA M GORDON is sponsoring a Phase 1/2 study, NCT05876715, for 40 patients with advanced Soft-tissue Sarcoma, investigating Lurbinectedin, Ipilimumab, and Nivolumab.
Jazz Pharmaceuticals is conducting a Phase 1/2 study, NCT05734066, for 60 pediatric and young adult participants with relapsed/refractory Ewing Sarcoma, focusing on Lurbinectedin monotherapy.
Fox Chase Cancer Center's Phase 2 study, NCT05800587, is recruiting 280 patients with Lung Cancer, Small-cell Lung Cancer, and Non Small Cell Lung Cancer, examining dose-attenuated chemotherapy regimens.
UNC Lineberger Comprehensive Cancer Center is sponsoring a Phase 2 study, NCT05578326, for 30 patients with Lung Cancer and Small-cell Lung Cancer, evaluating Trilaciclib and Lurbinectedin.
Emory University's Phase 1 trial, NCT05244239, aims to enroll 22 patients with extensive stage Small Cell Lung Cancer, assessing palliative radiotherapy with Lurbinectedin.
Where to Participate
Patients interested in participating in Lurbinectedin clinical trials have access to a wide network of research sites across the United States. These studies are being conducted in 94 locations across 59 cities in 30 states, ensuring broad geographic reach for potential participants.
The top cities hosting these trials include:
- Houston, Texas (7 sites)
- Los Angeles, California (6 sites)
- Philadelphia, Pennsylvania (5 sites)
- Atlanta, Georgia (4 sites)
- New York, New York (4 sites)
- Boston, Massachusetts (4 sites)
- Ann Arbor, Michigan (3 sites)
- Tampa, Florida (3 sites)
- Baltimore, Maryland (3 sites)
- Palo Alto, California (3 sites)
Eligibility criteria for these studies are inclusive, welcoming participants of all genders, with an age range from 2 to 120 years. Healthy volunteers are not eligible for these specific cancer trials, as participation is focused on individuals with the targeted medical conditions.
Development Timeline
The journey of Lurbinectedin began with its first clinical trial on September 26, 2013. Since then, its development has expanded significantly, with a total of 54 trials conducted or ongoing, involving an enrollment of 7,566 participants.
PharmaMar has been a primary driver of Lurbinectedin's research, sponsoring 15 trials, alongside contributions from other key organizations like Jazz Pharmaceuticals, M.D. Anderson Cancer Center, and the National Cancer Institute.
Initially, Lurbinectedin's investigation started with conditions such as IBS-C and hyperphosphatemia, but its focus quickly shifted and broadened to various types of cancer. The pipeline rapidly expanded to include Small-cell Lung Cancer, Relapsed Small Cell Lung Cancer, and Advanced Solid Tumors. Over time, the scope grew further to encompass conditions like Desmoplastic Small Round Cell Tumor, Ewing Sarcoma, Leiomyosarcoma, and Ovarian Cancer, among many others. This expansion reflects a strategic exploration of Lurbinectedin's potential across a diverse range of challenging malignancies. The development has progressed through various phases, with the majority being Phase 2 (19 trials) and Phase 1/2 (13 trials), indicating a strong focus on efficacy and dose optimization, complemented by 9 Phase 3 trials for late-stage evaluation. The latest trial is projected to conclude on March 10, 2026, highlighting ongoing commitment to its research.