Informations générales (source: ClinicalTrials.gov)
LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
décembre 2021
mai 2028
14 septembre 2025
The reason for this study is to see if the study drug, selpercatinib, compared to placebo
is effective and safe in delaying cancer return in participants with early-stage
non-small cell lung cancer (NSCLC), who have already had surgery or radiation.
Participants who are assigned to placebo and stop the study drug because their disease
comes back or gets worse have the option to potentially crossover to selpercatinib.
Participation could last up to three years.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 18/03/2024 11:06:13 | 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 Cochin | 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 | |||||
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone - 13385 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Centre Chirurgical Marie Lannelongue - 92350 - Le Plessis-Robinson - Hauts-de-Seine - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69373 - Lyon CEDEX 08 - Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
| CHU Charles Nicolle - 76031 - Rouen - Haute-Normandie - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Hopital Louis Pradel - 69677 - Lyon - Rhône - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
- Must have an activating RET gene fusion in tumor based on polymerase chain reaction
(PCR), next generation sequencing (NGS), or another molecular test per sponsor's
approval.
- Must have received definitive locoregional therapy with curative intent (surgery or
radiotherapy) for Stage IB, II, or IIIA NSCLC.
-- Must have undergone the available anti-cancer therapy (including chemotherapy or
durvalumab) or not be suitable for it, based on the investigator's discretion.
- Maximum time allowed between definitive therapy completion and randomization must
be:
- 10 weeks if no chemotherapy was administered
- 26 weeks if adjuvant chemotherapy was administered
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate hematologic, hepatic, and renal function.
- Willingness of men and women of reproductive potential to observe conventional and
highly effective birth control for the duration of the study and for at least 2
weeks after last dose of study drug.
- Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
- Must have an activating RET gene fusion in tumor based on polymerase chain reaction
(PCR), next generation sequencing (NGS), or another molecular test per sponsor's
approval.
- Must have received definitive locoregional therapy with curative intent (surgery or
radiotherapy) for Stage IB, II, or IIIA NSCLC.
-- Must have undergone the available anti-cancer therapy (including chemotherapy or
durvalumab) or not be suitable for it, based on the investigator's discretion.
- Maximum time allowed between definitive therapy completion and randomization must
be:
- 10 weeks if no chemotherapy was administered
- 26 weeks if adjuvant chemotherapy was administered
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate hematologic, hepatic, and renal function.
- Willingness of men and women of reproductive potential to observe conventional and
highly effective birth control for the duration of the study and for at least 2
weeks after last dose of study drug.
- Additional oncogenic drivers in NSCLC, if known.
- Evidence of small cell lung cancer.
- Clinical or radiologic evidence of disease recurrence or progression following
definitive therapy.
- Known or suspected interstitial fibrosis or interstitial lung disease or history of
(noninfectious) pneumonitis that required steroids.
- Clinically significant active cardiovascular disease or history of myocardial
infarction within six months prior to planned start of selpercatinib or prolongation
of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
greater than 470 milliseconds.
- Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
- Have known active hepatitis B or C.
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious
ongoing intercurrent illness, such as hypertension or diabetes, despite optimal
treatment.
- Major surgery within 4 weeks prior to planned start of selpercatinib.
- Clinically significant active malabsorption syndrome or other condition likely to
affect gastrointestinal absorption of the study drug.
- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or
other in situ cancers or a malignancy diagnosed greater than or equal to two years
previously and not currently active.
- Pregnancy or lactation.
- Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).