← Back to Search

Lurbinectedin + Radiotherapy for Soft Tissue Sarcoma

Phase 1 & 2

Waitlist Available

Led By Varun Monga, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Including metastatic (stage IV) disease for which radiotherapy and surgical resection of the primary tumor are indicated

Must not have

Prior history of trabectedin or lurbinectedin treatment

Known central nervous system (CNS) disease, except for treated brain metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effectiveness of combining lurbinectedin with radiotherapy in patients with locally advanced, resectable, high-grade sarcomas. It is being conducted at multiple centers and will

Who is the study for?

This trial is for individuals with locally advanced, high-grade soft tissue sarcomas that can be surgically removed. Participants must meet certain health standards to ensure they can safely receive the treatments.

What is being tested?

The study is testing how well lurbinectedin works alongside radiotherapy before surgery in patients with soft tissue sarcoma. It's an open-label trial, meaning everyone knows which treatment they're getting.

What are the potential side effects?

Potential side effects may include reactions related to lurbinectedin such as fatigue, nausea, hair loss, and lowered blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My cancer has spread and needs radiation or surgery.

Select...

My sarcoma is classified as grade 2 or 3.

Select...

My hepatitis B virus load is undetectable with treatment.

Select...

My tumor is at least 5 cm large and can be treated with radiation.

Select...

My sarcoma is in an arm, leg, trunk, or abdomen area and can be surgically removed.

Select...

I had hepatitis C but have been treated and cured.

Select...

I am mostly active and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with trabectedin or lurbinectedin before.

Select...

I have brain metastasis but it has been treated.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I am taking medication that strongly affects liver enzymes and cannot switch.

Select...

I am currently being treated for a collagen vascular disease.

Select...

I have received more than 20 Gy of radiation at the site of my current sarcoma diagnosis.

Select...

I have recovered from previous cancer treatment side effects, except for hair loss.

Select...

I need medication to prevent vomiting that is not rolapitant.

Select...

My cancer is one of the following types: GIST, desmoid, Ewing sarcoma, bone sarcomas, or Kaposi sarcoma.

Select...

I am not pregnant, as the medication in the study could harm a pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Local control rate (Phase 2, Cohort 2)

Maximum Tolerated Dose (MTD) (Phase 1b)

Overall response rate (Phase 2, Cohort 3)

+2 more

Secondary study objectives

Incidence of radiation related skin toxicity

Median Overall Survival (OS)

Median time to disease progression (TTP)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2, Cohort 3: Retroperitoneal sarcomaExperimental Treatment3 Interventions

Participants will receive the maximum tolerated dose of neoadjuvant lurbinectedin IV once every cycle (a cycle is 21 days) in combination with 6 weeks of pre-operative conventional external beam radiation therapy given as 45-50.4 Gy delivered over 25-28 fractions starting on cycle 1 for participants with retroperitoneal sarcoma. Non-investigational surgery will take place 4-6 weeks after completion of radiation therapy. Participants with metastatic disease at the time of study enrollment may be able to continue study treatment for 2 years from the time of initiating treatment. Participants with localized disease at the time of study enrollment may continue study treatment for approximately 3 months AND then be followed on-study surveillance.

Group II: Phase 2, Cohort 2: Extremity myxoid liposarcomaExperimental Treatment3 Interventions

Participants will receive the maximum tolerated dose of neoadjuvant lurbinectedin IV once every cycle (a cycle is 21 days) in combination with 2 weeks of pre-operative radiation given as 35 Gy in 5 fractions (gross tumor volume (GTV)) with fractions administered at least every other day starting on cycle 2 for participants with extremity myxoid Liposarcoma. Non-investigational surgery will take place 4-6 weeks after completion of radiation therapy. Participants with metastatic disease at the time of study enrollment may be able to continue study treatment for 2 years from the time of initiating treatment. Participants with localized disease at the time of study enrollment may continue study treatment for approximately 3 months AND then be followed on-study surveillance.

Group III: Phase 2, Cohort 1: Extremity and trunk sarcomaExperimental Treatment3 Interventions

Participants will receive the maximum tolerated dose of neoadjuvant lurbinectedin IV once every cycle (a cycle is 21 days) in combination with 2 weeks of pre-operative radiation given as 35 Gy in 5 fractions (gross tumor volume (GTV)) with fractions administered at least every other day starting on cycle 2 for participants with extremity and trunk sarcoma. Non-investigational surgery will take place 4-6 weeks after completion of radiation therapy. Participants with metastatic disease at the time of study enrollment may be able to continue study treatment for 2 years from the time of initiating treatment. Participants with localized disease at the time of study enrollment may continue study treatment for approximately 3 months AND then be followed on-study surveillance.

Group IV: Phase 1b, Cohort 3: Retroperitoneal SarcomaExperimental Treatment3 Interventions

Participants will receive up to 3.2 mg/m\^2 of neoadjuvant lurbinectedin IV once every cycle (a cycle is 21 days) in combination with 6 weeks of pre-operative conventional external beam radiation therapy given as 45-50.4 Gy delivered over 25-28 fractions starting on cycle 1 for participants with retroperitoneal sarcoma. Non-investigational surgery will take place 4-6 weeks after completion of radiation therapy. Participants with metastatic disease at the time of study enrollment may be able to continue study treatment for 2 years from the time of initiating treatment. Participants with localized disease at the time of study enrollment may continue study treatment for approximately 3 months AND then be followed on-study surveillance.

Group V: Phase 1b, Cohort 2 (Extremity Myxoid Liposarcoma)Experimental Treatment3 Interventions

Participants will receive up to 3.2 mg/m\^2 of neoadjuvant lurbinectedin IV once every cycle (a cycle is 21 days) in combination with 2 weeks of pre-operative radiation given as 35 Gy in 5 fractions (gross tumor volume (GTV)) with fractions administered at least every other day starting on cycle 2 for participants with extremity myxoid Liposarcoma. Non-investigational surgery will take place 4-6 weeks after completion of radiation therapy. Participants with metastatic disease at the time of study enrollment may be able to continue study treatment for 2 years from the time of initiating treatment. Participants with localized disease at the time of study enrollment may continue study treatment for approximately 3 months AND then be followed on-study surveillance.

Group VI: Phase 1b, Cohort 1 (Extremity and Trunk Sarcoma)Experimental Treatment3 Interventions

Participants will receive up to 3.2 mg/m\^2 of neoadjuvant lurbinectedin IV once every cycle (a cycle is 21 days) in combination with 2 weeks of pre-operative radiation given as 35 Gy in 5 fractions (gross tumor volume (GTV)) with fractions administered at least every other day starting on cycle 2 for participants with extremity and trunk sarcoma. Non-investigational surgery will take place 4-6 weeks after completion of radiation therapy. Participants with metastatic disease at the time of study enrollment may be able to continue study treatment for 2 years from the time of initiating treatment. Participants with localized disease at the time of study enrollment may continue study treatment for approximately 3 months AND then be followed on-study surveillance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

Lurbinectedin

2022

Completed Phase 3

~780