Description:
Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus
cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as
treatment in patients with small-cell lung cancer (SCLC) who failed one prior
platinum-containing line.
Title
- Brief Title: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
- Official Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
Clinical Trial IDs
- ORG STUDY ID:
PM1183-C-003-14
- NCT ID:
NCT02566993
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Lurbinectedin (PM01183) | | Experimental Arm |
Doxorubicin (DOX) | | Control Arm 1 |
Cyclophosphamide (CTX) | | Control Arm 1 |
Vincristine (VCR) | | Control Arm 1 |
Topotecan | | Control Arm 2 |
Purpose
Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus
cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as
treatment in patients with small-cell lung cancer (SCLC) who failed one prior
platinum-containing line.
Detailed Description
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and
compare the activity and safety of an experimental arm consisting of PM01183/DOX combination
followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or
topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line
but no more than one prior chemotherapy-containing line.
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental Arm | Experimental | Lurbinectedin (PM01183) / Doxorubicin | - Lurbinectedin (PM01183)
- Doxorubicin (DOX)
|
Control Arm 1 | Active Comparator | CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR)) | - Doxorubicin (DOX)
- Cyclophosphamide (CTX)
- Vincristine (VCR)
|
Control Arm 2 | Active Comparator | Topotecan | |
Eligibility Criteria
Inclusion Criteria:
1. Voluntary written informed consent
2. Adult patients ≥ 18 years
3. Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC
which failed one prior platinum-containing regimen and with a chemotherapy-free
interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence
of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with
or without neuroendocrine features confirmed in histology test(s) performed on
metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
5. Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior
to randomization
6. At least three weeks since last prior anticancer treatment and adequate recovery from
prior treatment toxicity
7. Prior radiotherapy (RT): At least four weeks since completion of whole-brain
irradiation, at least two weeks since completion of prophylactic cranial irradiation,
and to any other site.
8. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP
must agree to use a highly effective contraceptive measure up to six weeks after
treatment discontinuation. Fertile male patients with WOCBP partners should use
condoms during treatment and for four months following the last investigational
medicinal product dose.
Exclusion Criteria:
1. More than one prior chemotherapy-containing line(re-challenge with the same initial
regimen is not allowed)
2. Patients who never received platinum-containing regimen for Small-cell Lung Cancer
(SCLC)
3. Prior treatment with PM01183, topotecan or anthracyclines.
4. Limited-stage patients who are candidates for local or regional therapy
5. Impending need for palliative RT or surgery for pathological fractures and/or for
medullary compression within four weeks prior to randomization.
6. Symptomatic or progressing or steroid requiring Central Nervous System (CNS)
involvement disease at least four weeks prior to randomization
7. Concomitant diseases/conditions:
Angina, myocardial infarction, congestive heart failure or clinically significant
valvular heart disease, arrhythmia, immunodeficiency (including known HIV
seropositive), ongoing or treatment-requiring chronic liver disease, active infection,
oxygen requirement within two weeks prior to randomization, diffuse interstitial lung
disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with
chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic
treatment within 12 weeks of randomization.
8. Pregnant or breast feeding women
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Every three months up to death or study termination (aprox. 10 months) |
Safety Issue: | |
Description: | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) |
Time Frame: | Every six weeks up to progression disease (aprox. 5 months) |
Safety Issue: | |
Description: | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. |
Measure: | Best antitumor response |
Time Frame: | Every three months up to death or study termination (aprox. 24 months) |
Safety Issue: | |
Description: | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | PharmaMar |
Last Updated
March 10, 2020