Informations générales (source: ClinicalTrials.gov)
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 Patients (LAGOON Trial)
Interventional
Phase 3
PharmaMar (Voir sur ClinicalTrials)
juillet 2022
avril 2026
03 août 2024
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and
compare the activity and safety of two experimental arms consisting of lurbinectedin as
single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B)
versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in
Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle MONNET | 29/03/2024 01:30:25 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 18/03/2024 11:06:09 | Contacter | ||
| HOPITAL FOCH | Jaafar BENNOUNA | 21/10/2024 07:07:23 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire CHU De Limoges - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU de Caen - Hopital Cote de Nacre - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - Cedex 01 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Reims - Hpital Maison Blanche - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Hopital Civil / Nouvel Hopital Civil - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hopital Morvan CHU de Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Voluntary written informed consent of the patient obtained before any study-specific
procedure
2. Age≥18 years
3. Histologically or cytologically confirmed diagnosis of SCLC.
4. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or
anti-PD-L1 (Note: at least 70% of patients included in the study have to be
pretreated with anti-PD-1 or anti-PD-L1)
5. Chemotherapy-free interval (CTFI, time from the last dose of first-line
platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days
(independent of the immunotherapy maintenance, if applicable)
6. Patients with history of Central Nervous System (CNS) metastases can participate
provided they are pretreated and radiologically stable (i.e., without evidence of
progression) for at least 4 weeks by repeated imaging (note: repeated imaging should
be performed during study screening), asymptomatic, and without requirement of
steroid treatment for at least 7 days before the first dose of study treatment
7. Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
8. Adequate hematological, renal, metabolic and hepatic function:
1. Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC)
transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x
10^9/L, and platelet count ≥ 100 x 10^9/L.
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x
upper limit of normal (ULN).
3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
4. Albumin ≥ 3.0 g/dL.
5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's
formula).
9. At least three weeks since last prior antineoplastic treatment and recovery to grade
≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding
sensory neuropathy, anemia, asthenia and alopecia, all grade ≤ 2) according to the
National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE)
v.5.
10. Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial
irradiation (PCI), and to any other site not previously specified.
11. Evidence of non-childbearing status for women of childbearing potential (WOCBP).
WOCBP must agree to use a highly effective contraceptive measure up to seven months
after treatment discontinuation. Fertile male patients with WOCBP partners should
use condoms during treatment and for four months following the last investigational
medicinal product (IMP) dose.
1. Voluntary written informed consent of the patient obtained before any study-specific
procedure
2. Age≥18 years
3. Histologically or cytologically confirmed diagnosis of SCLC.
4. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or
anti-PD-L1 (Note: at least 70% of patients included in the study have to be
pretreated with anti-PD-1 or anti-PD-L1)
5. Chemotherapy-free interval (CTFI, time from the last dose of first-line
platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days
(independent of the immunotherapy maintenance, if applicable)
6. Patients with history of Central Nervous System (CNS) metastases can participate
provided they are pretreated and radiologically stable (i.e., without evidence of
progression) for at least 4 weeks by repeated imaging (note: repeated imaging should
be performed during study screening), asymptomatic, and without requirement of
steroid treatment for at least 7 days before the first dose of study treatment
7. Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
8. Adequate hematological, renal, metabolic and hepatic function:
1. Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC)
transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x
10^9/L, and platelet count ≥ 100 x 10^9/L.
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x
upper limit of normal (ULN).
3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
4. Albumin ≥ 3.0 g/dL.
5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's
formula).
9. At least three weeks since last prior antineoplastic treatment and recovery to grade
≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding
sensory neuropathy, anemia, asthenia and alopecia, all grade ≤ 2) according to the
National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE)
v.5.
10. Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial
irradiation (PCI), and to any other site not previously specified.
11. Evidence of non-childbearing status for women of childbearing potential (WOCBP).
WOCBP must agree to use a highly effective contraceptive measure up to seven months
after treatment discontinuation. Fertile male patients with WOCBP partners should
use condoms during treatment and for four months following the last investigational
medicinal product (IMP) dose.
1. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy
regimen (including patients re-challenged with same initial regimen).
2. Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors
(irinotecan, topotecan, etc.).
3. Active or untreated CNS metastases and/or carcinomatous meningitis.
4. Patients with limited-stage disease who are candidates for local or regional
therapy, including PCI, thoracic RT or both, must have been offered that option and
completed treatment or refused it prior to randomization.
5. Concomitant diseases/conditions:
1. History or presence of unstable angina, myocardial infarction, congestive heart
failure, or clinically significant valvular heart disease within last year.
2. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing
treatment.
3. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
4. Known Gilbert's disease.
5. Active uncontrolled infection. Serious non-healing wound, ulcer or bone
fracture. Presence of external drainages.
6. Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any
origin. For Hepatitis B, this includes positive tests for both Hepatitis B
surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction
(PCR). For Hepatitis C, this includes positive tests for both Hepatitis C
antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related
antiviral therapy within six months prior to the first dose of study drugs will
also be excluded.
7. Intermittent or continuous oxygen requirement within two weeks prior to
randomization. Patients with confirmed or suspected diagnosis of diffuse
interstitial lung disease or pulmonary fibrosis.
8. Patients with a second invasive malignancy treated with chemotherapy and/or RT.
Patients with a previous malignancy that was completely resected with curative
intention three or more years prior to randomization, except treated in situ
carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ
transitional cell bladder carcinoma and who has been continuously in remission
since then will be permitted.
9. Limitation of the patient's ability to comply with the treatment or to follow
the protocol.
10. Documented or suspected invasive fungal infections requiring systemic treatment
within 12 weeks of randomization.
11. Known human immunodeficiency virus (HIV) infection.
12. Any past or present chronic inflammatory colon and/or liver disease, past
intestinal obstruction, pseudo or subocclusion or paralysis.
13. Evident symptomatic pleural or cardiac effusion rapidly increasing and/or
necessitating prompt local treatment within seven days.
14. Any other major illness that, in the Investigator's judgment, will
substantially increase the risk associated with the patient's participation in
this study (e.g.; COVID-19 disease).
6. RT in more than 35% of the bone marrow.
7. History of previous bone marrow and/or stem cell transplantation and allogenic
transplant.
8. Patient has received a live or live-attenuated vaccine within 30 days before the
first dose of study intervention. Administration of inactivated vaccines is allowed.
9. Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord
compression).
10. History of allergy or hypersensitivity to any of the study drugs or any of their
excipients.
11. Women who are pregnant or breast feeding and fertile patients (men and women) who
are not able to use a highly effective method of contraception