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Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

ConditionsNSCLC Stage IIIEnsartinibChemoradiotherapyALK
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged at least 18 years

Histologically or cytologically confirmed Stage III unresectable non-small cell lung cancer (NSCLC) with curative treatment intent

ALK mutations assessed by FISH, IHC, or NGS

ECOG Performance Status of 0 or 1

Disqualifiers

Mixed histology of small cell and non-small cell lung cancer

Symptomatic pneumonitis following chemoradiotherapy that has not resolved to ≤ Grade 1 (per CTCAE criteria) prior to randomization;

Any unresolved toxicity from prior chemoradiotherapy with toxicity ≥ Grade 2 (according to CTCAE criteria);

Mean resting corrected QT interval (QTc) > 470 msec (obtained from 3 ECGs);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ensartinib 225mg

    Drug

    225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met

  • Placebo Ensartinib 225mg

    Drug

    225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: EnsartinibExperimental treatment 1 intervention
Group B: Placebo EnsartinibPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

progressive free survival

disease progression according to RSCIST v1.1 or intolerable toxicity according to CTCAE v5.0

Time frame
From enrollment to the end of treatment, up to 100 months

Secondary outcomes

1

Objective Response Rate

ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1

Time frame
From first dose of study drug until disease progression, assessed up to approximately 12 months
2

Disease Control Rate

DCR is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST 1.1

Time frame
From first dose of study drug until disease progression, assessed up to approximately 12 months
3

Overall Survival (OS)

OS is defined as the time from randomization until death due to any cause.

Time frame
From randomization until death from any cause, up to 120 months
4

Central Nervous System Progression-Free Survival (CNS-PFS)

CNS-PFS is defined as the time from randomization to the first documented intracranial progression (as assessed by MRI ) or death from any cause, whichever occurs first.

Time frame
From randomization until CNS progression or death, up to 100 months

Other outcomes

1

Exploratory Analysis of Biomarkers and Efficacy

To explore the correlation between potential biomarkers and efficacy outcomes (PFS/ORR/DCR/OS/CNS-PFS) through analysis of blood samples

Time frame
Blood samples will be collected at the following time points: before chemoradiotherapy, within 6 weeks after chemoradiotherapy, at 6 months of medication, and through study completion, an average of 5 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: