WithdrawnPhase 1/2

Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas

Stopped: Business decision

0Started 2024-10-31

Plain-language summary

This is a multi-center, multi-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent lurbinectedin in combination with radiotherapy in patients with locally advanced, resectable, high-grade sarcomas.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have histologically or cytologically confirmed diagnosis of locally advanced soft tissue sarcoma of extremity, trunk or retroperitoneum that is resectable and for which preoperative radiotherapy is considered appropriate.
✓. Including metastatic (stage IV) disease for which radiotherapy and surgical resection of the primary tumor are indicated.
✓. Grade 1 myxoid liposarcoma can be included if preoperative radiotherapy is considered appropriate.
✓. For all other sarcomas, only grade 2 or 3 will be included.
✓. Those with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
✓. Must have measurable disease defined as a tumor size at least \>= 5 cm in the longest diameter as measured by Computerized tomography (CT) scan or Magnetic resonance imaging (MRI) for which radiation is feasible and indicated.
✓. Age \>=18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 (Karnofsky ≥ 70%).

Exclusion criteria

✕. Has the following histologic subtypes: gastrointestinal stromal tumor (GIST), desmoid, Ewing sarcoma, bone sarcomas, Kaposi sarcoma.
✕. Prior history of trabectedin or lurbinectedin treatment.
✕. Prior radiation therapy in excess of 20 Gray (Gy) conventionally fractionated radiotherapy (RT) to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
✕. Currently receiving treatment in another invasive investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
✕. Known central nervous system (CNS) disease, except for treated brain metastasis: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS); Gamma Knife, linear particle accelerator (LINAC), or equivalent) or a combination as deemed appropriate by the treating physician. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Participants on strong or moderate cytochrome P450 (CYP)3A inducers or inhibitors and cannot be substituted for other drugs.

What they're measuring

Proportion of participants with dose-limiting toxicities (DLTs) (Phase 1b)

Timeframe: 4 weeks

Maximum Tolerated Dose (MTD) (Phase 1b)

Timeframe: Up to 6 months

Pathological necrosis rate (Phase 2, Cohort 1)

Timeframe: Up to 12 weeks

Local control rate (Phase 2, Cohort 2)

Timeframe: Up to 12 weeks

Overall response rate (Phase 2, Cohort 3)

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT06217536

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Locally Advanced Soft Tissue Sarcoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have histologically or cytologically confirmed diagnosis of locally advanced soft tissue sarcoma of extremity, trunk or retroperitoneum that is resectable and for which preoperative radiotherapy is considered appropriate.
✓. Including metastatic (stage IV) disease for which radiotherapy and surgical resection of the primary tumor are indicated.
✓. Grade 1 myxoid liposarcoma can be included if preoperative radiotherapy is considered appropriate.
✓. For all other sarcomas, only grade 2 or 3 will be included.
✓. Those with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
✓. Must have measurable disease defined as a tumor size at least \>= 5 cm in the longest diameter as measured by Computerized tomography (CT) scan or Magnetic resonance imaging (MRI) for which radiation is feasible and indicated.
✓. Age \>=18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 (Karnofsky ≥ 70%).

Exclusion criteria

✕. Has the following histologic subtypes: gastrointestinal stromal tumor (GIST), desmoid, Ewing sarcoma, bone sarcomas, Kaposi sarcoma.
✕. Prior history of trabectedin or lurbinectedin treatment.
✕. Prior radiation therapy in excess of 20 Gray (Gy) conventionally fractionated radiotherapy (RT) to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
✕. Currently receiving treatment in another invasive investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
✕. Known central nervous system (CNS) disease, except for treated brain metastasis: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS); Gamma Knife, linear particle accelerator (LINAC), or equivalent) or a combination as deemed appropriate by the treating physician. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Participants on strong or moderate cytochrome P450 (CYP)3A inducers or inhibitors and cannot be substituted for other drugs.

What they're measuring

Proportion of participants with dose-limiting toxicities (DLTs) (Phase 1b)

Timeframe: 4 weeks

Maximum Tolerated Dose (MTD) (Phase 1b)

Timeframe: Up to 6 months

Pathological necrosis rate (Phase 2, Cohort 1)

Timeframe: Up to 12 weeks

Local control rate (Phase 2, Cohort 2)

Timeframe: Up to 12 weeks

Overall response rate (Phase 2, Cohort 3)

Timeframe: Up to 12 weeks