A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients

NCT01951157 | Completed Phase 2 Results

• 1 other identifier: PM1183-B-004-13
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at Four Months (PFS4)

  The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

  At month four after patient inclusion

Secondary Outcomes (7)

• Progression-free Survival

  Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years

• Progression-free Survival Rate at Six Months (PFS6)

  At month six after patient inclusion

• Overall Response Rate

  Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years

• Objective Response Per RECIST v.1.1

  Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years

• Duration of Response

  The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years

Study Arms (3)

A - docetaxel

ACTIVE COMPARATOR

75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks

Drug: Docetaxel

B - lurbinectedin (PM01183)

EXPERIMENTAL

3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks

Drug: Lurbinectedin (PM01183)

C - gemcitabine + lurbinectedin (PM01183)

EXPERIMENTAL

800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks

Drug: Gemcitabine; Drug: Lurbinectedin (PM01183)

Interventions

Docetaxel DRUG

Powder for solution for infusion

A - docetaxel

Gemcitabine DRUG

Powder for solution for infusion

C - gemcitabine + lurbinectedin (PM01183)

Lurbinectedin (PM01183) DRUG

Powder for concentrate for solution for infusion

B - lurbinectedin (PM01183); C - gemcitabine + lurbinectedin (PM01183)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed unresectable NSCLC
• Patients must have failed one prior line of CT-based therapy for unresectable disease
• Age between 18 and 75 years
• Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1
• Adequate hematological, renal, metabolic and hepatic function
• At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy
• Negative pregnancy test for pre-menopausal women

You may not qualify if:

• Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness
• Histological features of neuroendocrine or bronchioalveolar differentiation.
• Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma.
• Prior or concurrent invasive malignant disease, unless in complete remission for more than three years.
• Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start
• Prior treatment with docetaxel-containing therapy
• Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement
• Paraneoplastic syndromes

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (1)

Unknown Facility

New York, New York, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Gemcitabine; PM 01183

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Pharma Mar S.A.
• Organization: Pharma Mar S.A.

clinicaltrials@pharmamar.com

00 34 91846 60 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 26, 2013
• Study Start: September 11, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09

Locations

US (1)