ATLANTIS Trial
Research type
Research Study
Full title
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 (ATLANTIS Trial)
IRAS ID
191705
Contact name
Martin Forster
Contact email
Sponsor organisation
Pharma Mar S.A.
Eudract number
2015-001641-89
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 21 days
Research summary
The main aim of this clinical trial is to know if lurbinectedin (PM01183) when administered in combination with doxorubicin (DOX) is superior to the currently available standard treatments of topotecan, a drug used and approved to treat this condition in the United States, the European Union and most Western countries or a combination of cyclophosphamide, Doxorubicin and vincristine (known as CAV), a drug combination used in England and parts of Europe, in controlling small cell lung cancer (SCLC)in patients who had progressed after receiving a platinum-containing line of treatment. Also the global effects (good or bad) of this combination will be compared to those of topotecan and CAV. The knowledge obtained from this treatment combination may allow a new way to fight against this type of cancer.
PM01183 is a novel anticancer drug that is ongoing clinical testing because of the antitumor activity shown in laboratory tests, and its adequate safety profile in animals and humans. To date, more than 600 participants have been treated with PM01183 alone or in combination with other drugs in clinical studies.
Eligibility: Adult participants aged ≥ 18 years with Eastern Cooperative Oncology Group Performance Status (ECOG PS 0-2) who have failed one prior platinum-containing line but not more than one chemotherapy (CHT)-containing line (re-challenge is not allowed) without symptomatic or progressing Central Nervous System (CNS) involvement at randomisation.
Approximately 600 participants with SCLC for whom one prior platinum-containing chemotherapy line failed will be stratified and randomised at a 1:1 ratio over 17 months (~35 patients/month). Participants will be in the study for approximately 35 months (2 years 11 months)
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1222
Date of REC Opinion
5 Sep 2016
REC opinion
Further Information Favourable Opinion