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

Browse trials for

• Lung Neoplasms 7,243
• Carcinoma, Non-Small-Cell Lung 6,488

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 69 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

PharmaMar is the lead sponsor of 50 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Study arms

• Active comparator
  A - docetaxel

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

  Drug: Docetaxel

• Experimental
  B - lurbinectedin (PM01183)

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

  Drug: Lurbinectedin (PM01183)

• Experimental
  C - gemcitabine + lurbinectedin (PM01183)

  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

• DrugDocetaxel

  Powder for solution for infusion

• DrugGemcitabine

  Powder for solution for infusion

• DrugLurbinectedin (PM01183)

  Powder for concentrate for solution for infusion

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.

   Time frame: At month four after patient inclusion

Secondary outcomes

1. Progression-free Survival

   PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. 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.

   Time frame: 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

2. Progression-free Survival Rate at Six Months (PFS6)

   The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (\~6 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.

   Time frame: At month six after patient inclusion

3. Overall Response Rate

   Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

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

4. Objective Response Per RECIST v.1.1

   RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10mm Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Appearance of new lesions was considered PD Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF) Symptomatic deterioration/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed

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

5. Duration of Response

   Duration of response (DR) was defined as 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. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

   Time frame: 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

6. Overall Survival (OS)

   Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact

   Time frame: From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion

7. Information on Quality of Life (QoL)

   The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy. Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)

   Time frame: Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)

Baseline characteristics

15 further baseline measures are reported on the registry.