Informations générales (source: ClinicalTrials.gov)
An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations
Interventional
Phase 1/Phase 2
AbbVie (Voir sur ClinicalTrials)
mars 2025
novembre 2027
13 août 2025
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype
of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose
of this study is to assess adverse events and change in disease activity when
Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death
receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC.
ABBV-400 and budigalimab are investigational drugs being developed for the treatment of
NSCLC. This study will be divided into two stages, with the first stage treating
participants with several doses of ABBV-400 in combination with budigalimab within the
dose escalation regimen until the dose reached is tolerable and expected to be
efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive
budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the
best dose to be studied in the future). One group will receive budigalimab, pemetrexed,
and investigator's choice of carboplatin or cisplatin, followed by budigalimab and
pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed,
and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and
pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study
in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous
(IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of
Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose
optimization stage participants will be receive IV optimized doses of Telisotuzumab
Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and
investigator's choice of carboplatin or cisplatin, followed by budigalimab and
pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin
or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration
of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, questionnaires and side effects.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | 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 Antoine-Lacassagne /ID# 268486 - 06189 - Nice - Provence-Alpes-Cote-d Azur - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - Hopital Laennec /ID# 268475 - 44800 - Saint-Herblain - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Must have histologically documented non-squamous (NSq) non small cell lung carcinoma
(NSCLC) that is locally advanced or metastatic will be enrolled into the study.
- Must have measurable disease per response evaluation criteria in solid tumors
(RECIST) v1.1.
- For Part 1, participants must have had no more than 1 systemic therapy for advanced
disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as
monotherapy or in combination with chemotherapy), or appropriate targeted therapy
for an actionable gene alteration, if applicable, for epidermal growth factor
receptor (EGFR) wild-type (WT) NSq NSCLC.
- For Part 2, participants must have no prior systemic therapy for advanced disease,
no known actionable genomic alteration.
- Must have documented programmed death ligand 1 (PD-L1) status.
- Must have adequate organ function.
- Must have histologically documented non-squamous (NSq) non small cell lung carcinoma
(NSCLC) that is locally advanced or metastatic will be enrolled into the study.
- Must have measurable disease per response evaluation criteria in solid tumors
(RECIST) v1.1.
- For Part 1, participants must have had no more than 1 systemic therapy for advanced
disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as
monotherapy or in combination with chemotherapy), or appropriate targeted therapy
for an actionable gene alteration, if applicable, for epidermal growth factor
receptor (EGFR) wild-type (WT) NSq NSCLC.
- For Part 2, participants must have no prior systemic therapy for advanced disease,
no known actionable genomic alteration.
- Must have documented programmed death ligand 1 (PD-L1) status.
- Must have adequate organ function.
- Known uncontrolled metastases to the central nervous system.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment
with systemic steroids, or any evidence of active ILD or pneumonitis on screening
chest computed tomography (CT) scan.