Lagoon trial
Research type
Research Study
Full title
A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer (SCLC) Patients (LAGOON Trial)
IRAS ID
1004977
Contact name
M José Arce Tomas
Contact email
Sponsor organisation
Pharma Mar, S.A.
Eudract number
2021-004471-13
Clinicaltrials.gov Identifier
Research summary
Ca. 13-15% of all lung cancer cases are small cell lung cancer (SCLC). This type of lung cancer may grow quickly, spread throughout the body and return even after treatment. The LAGOON clinical research study is testing an investigational/study drug for adults with relapsed (returned after previous cancer treatment) SCLC. The study tests the study drug lurbinectedin to find out how well it works compared to chemotherapy. A study drug has not yet been approved for use by the general public.
Ca. 705 participants will be included globally. They must be at least 18 years old, have a diagnosis of relapsed SCLC and have received at least one prior chemotherapy treatment with or without an antiPD-1/anti-PDL1 agent (immunotherapy agent).
The study duration varies per participant. After a screening period of a maximum of 4 weeks (when eligibility to participate is checked), the study consists of 3-week study treatment cycles. Participants will stay in the study until they decide to leave it or start new cancer therapy. After study treatment ends, participants will be followed every 3-6 months until completion of the entire study, which could take months or years.
Participants will be assigned to a study group randomly (like drawing straws) and receive either lurbinectedin alone, a combination of lurbinectedin and irinotecan (chemotherapy drug), or chemotherapy (topotecan or irinotecan). The group allocation is know to both the participant and the study doctor. Most of the drugs will be given by intravenous infusions (through a vein) once every 3 weeks (Day 1 of each cycle). Participants also visit the site on Day 8 of each cycle for tests. Topotecan may be given as a capsule taken by mouth.
Tumour assessments by CT scan or MRI will occur every 6 weeks throughout the study. Laboratory tests, physical exams, questionnaires and other tests will also be among study procedures.
The study is funded by Pharma Mar, S.A., a pharmaceutical company based in the US and Spain.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0131
Date of REC Opinion
31 Aug 2022
REC opinion
Further Information Favourable Opinion