Clinical trial · Expanded Access

A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA

NCT04291937CI-TRIAL-00045620approved for marketingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Small Cell Lung Cancer	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Lurbinectedin	Drug	Lurbinectedin	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Legally competent adult
* Confirmed and unresectable Small Cell Lung Cancer (SCLC)
* Patients must have received one prior chemotherapy containing line
* Adequate organ, hematological, kidney, metabolic and liver function
* Recovery from toxicities related to previous treatment(s)
* Pregnancy must be excluded, medically acceptable contraception method

Exclusion Criteria:

* Prior treatment with lurbinectedin
* Certain concomitant diseases/conditions
* Symptomatic, steroid-requiring or progressive CNS involvement.
* Pregnant or breast-feeding women.

References

Publications (0)

Data not yet available

No reference posted for this study.