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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200481
Other study ID # IFCT-2101
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 18, 2022
Est. completion date October 2028

Study information

Verified date March 2024
Source Intergroupe Francophone de Cancerologie Thoracique
Contact Opérations Cliniques
Phone +33156811045
Email contact@ifct.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.


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Study Design


Intervention

Drug:
Brigatinib 180 MG
Patients will receive brigatinib orally at a dose of 90 mg QD for a 7 days lead-in period followed by 180 mg QD continuously, with or without food, in 28-day cycles until progression. Dose reductions are possible.
Carboplatin
Patients will receive pemetrexed 500 mg/m² followed by carboplatin to target AUC of 5 mg/mL/min both on Day 1 as IV infusion every 3 weeks for 4 infusions. The first infusion of carboplatin and pemetrexed will be administrated at day 8 of brigatinib treatment, at time of dose escalation from 90 mg QD to 180mg QD continuously.
Pemetrexed
Patients will receive pemetrexed 500 mg/m² followed by carboplatin to target AUC of 5 mg/mL/min both on Day 1 as IV infusion every 3 weeks for 4 infusions. The first infusion of carboplatin and pemetrexed will be administrated at day 8 of brigatinib treatment, at time of dose escalation from 90 mg QD to 180mg QD continuously.

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Sponsors (1)

Lead Sponsor Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival at 12 months, investigator assessment Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause), determined by investigator assessment. 12 months
Secondary Progression Free Survival at 12 months, independent review Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause), determined by independent review. 12 months
Secondary Overall Response Rate Proportion of patients who have achieved a best overall response of complete response or partial response (RECIST1.1), determined by investigator assessment and by independent review. At progression, after an average of 2 years
Secondary Incidence, nature, and severity of adverse events Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). From time of informed consent through treatment period and up to 30 days post last dose of study treatment (average of 2 years)
Secondary Impact of ALK fusion detection in ctDNA on 12-months progression free survival Proportion of patients who achieved progression free survival (RECIST1.1) with ALK fusion detection in ctDNA baseline liquid biopsy. 12 months
Secondary Impact of ALK fusion detection in ctDNA on overall response rate Proportion of patients who have achieved a best overall response of complete response or partial response (RECIST1.1) with ALK fusion detection in ctDNA baseline liquid biopsy. At progression, after an average of 2 years
Secondary Intracranial overall response rate Proportion of patients who have achieved a best overall response of complete response or partial response of the baseline measurable and non-measurable CNS disease (RECIST1.1 + RANO), determined by investigator assessment and by independent review. At progression, after an average of 2 years
Secondary Intracranial progression free survival at 12 months Time from enrollment to first observation of progression of the baseline measurable and non-measurable CNS disease (RECIST1.1 + RANA), determined by investigator assessment and by independent review. 12 months
Secondary Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) at all scheduled time points. From enrollment to end of treatment, after an average of 2 years
Secondary Time until definitive health related quality of life score deterioration The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-LC13 questionnaire will be used to determine time until definitive HRQoL score deterioration. From enrollment to score deterioration, a period of up to 2 years
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