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
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
Treatments tested in this trial
- Ensartinib 225mg
- Placebo Ensartinib 225mg