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The ALEX trial: Study design1,2

 

ALEX was a Phase III, global, open-label, randomized study comparing ALECENSA with crizotinib in patients with previously untreated, advanced ALK+ NSCLC, including those with previously asymptomatic CNS disease.1

 

The J-ALEX trial: study design3,4

 

J-ALEX was a Phase III, open-label, randomized multicenter study comparing ALECENSA with crizotinib in ALK inhibitor-naive Japanese patients with advanced ALK+ NSCLC who were either chemotherapy-naive, or who had received one previous chemotherapy regimen.3,4 Patients with pre-treated or asymptomatic brain metastases were eligible for inclusion.3,4

 

The ALUR trial: study design5,6

 

ALUR was a Phase III, open-label, randomized, multicenter study comparing ALECENSA with crizotinib in patients with advanced ALK+ NSCLC who had previously received two prior lines of systemic therapy.5,6

 

The ALESIA trial: study design7,8

 

ALESIA was a Phase III, open-label, randomized multicenter study carried out in China, South Korea and Thailand, which compared ALECENSA with crizotinib in treatment-naive Asian patients with advanced ALK+ NSCLC.7,8

 

The ALINA trial: ALECENSA as an adjuvant treatment in early-stage ALK+ NSCLC9

 

ALINA is a global, open-label, Phase III, randomized trial investigating the efficacy and safety of adjuvant ALECENSA vs. platinum-based chemotherapy.9    

Primary endpoint: Disease-free survival‡‡

Secondary endpoints: OS and safety

Exploratory endpoints: CNS disease-free survival§§

 

The BFAST trial: ALECENSA in treatment-naive advanced or metastatic ALK+ NSCLC assessed via NGS10,11

 

The Blood First Assay Screening trial (BFAST), is an ongoing, open label, multicohort study, prospectively evaluating the relationship between blood-based next-generation sequencing (NGS) detection of actionable genetic alterations and activity of targeted therapies or immunotherapy in treatment-naive advanced or metastatic NSCLC.10,11

Inclusion criteria:

ALK+ Stage IIIB or IV NSCLC, detected by blood-based NGS using hybrid-capture technology

 

600 mg

ALECENSA BID

 

 

Inclusion criteria:

ALK+ Stage IIIB or IV NSCLC, detected by blood-based NGS using hybrid-capture technology

 

600 mg

ALECENSA BID

 

 

Primary endpoint: Confirmed investigator-assessed ORR

Secondary endpoints: Confirmed ORR∥∥, DoR¶¶, CBR¶¶, PFS¶¶, OS¶¶ and safety¶¶

Exploratory endpoints: Anti-tumor effect of ALECENSA in patients with CNS disease at baseline

 

Median survival follow-up was 52.0 months11

Median PFS:

33.0 months

(95% CI: 20.5–44.2)11

ORR:

89.7%

(95% CI: 81.3–95.2)11

Median DoR:

35.1 months

(95% CI: 24.8–49.7)11

OS rate at 48-months:

58.3%

(95% CI: 47.8–68.7)11

Median PFS:

33.0 months

(95% CI: 20.5–44.2)11

ORR:

89.7%

(95% CI: 81.3–95.2)11

Median DoR:

35.1 months

(95% CI: 24.8–49.7)11

OS rate at 48-months:

58.3%

(95% CI: 47.8–68.7)11

First-line detection of ALK fusions using an NGS assay in BFAST predicted for high ORR and significant clinical benefit in patients with metastatic NSCLC receiving ALECENSA.10

 

HORIZON-01: ALECENSA in unresectable Stage III ALK+ NSCLC12

 

HORIZON-01 is a Phase I–III global, open label, randomized multicenter study evaluating the efficacy and safety of multiple targeted therapies compared with durvalumab, following CRT in patients with locally-advanced, unresectable, Stage III NSCLC, selected according to their biomarker status.12

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*According to RECIST v.1.1.2–5,8 †Assessed by BICR.1 ‡For patients with baseline CNS metastases.5,6 §Pemetrexed 500 mg/m2 or docetaxel 75 mg/m2 at the investigators’ discretion.5,6 ∥At the investigator’s discretion, ALECENSA could be continued until loss of clinical benefit.5,6 ¶In patients with measurable CNS disease at baseline.5,6 **Per UICC/AJCC 7th edition.9 ††Cisplatin + pemetrexed, cisplatin + vinorelbine or cisplatin + gemcitabine; cisplatin could be switched to carboplatin in case of intolerability.9 ‡‡Defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator or death from any cause.9 §§Defined as time from randomization to the first documented recurrence of disease in the CNS or death from any cause.9 ∥∥Independent review facility-assessed.10 ¶¶Investigator- and independent review facility-assessed.10 ***Eligible biomarker status per central testing under BIOSTART or a local tissue-based test.12 †††Target population.12 ‡‡‡Defined as the time from randomization to the first documented disease progression, as determined by BICR per RECIST v1.1, or death from any cause, whichever occurs first.12 §§§All by BICR and investigator assessment per RECIST.12

 

1L, first-line therapy; 2L, second-line therapy; AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; BFAST, Blood First Assay Screening Trial; BICR, blinded independent central review; BID, twice daily; CBR, confirmed best response; cCRT, concurrent chemoradiotherapy; CI, confidence interval; CNS, central nervous system; CRT, chemoradiotherapy; DCR, disease control rate; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HRQoL, health-related quality of life; IHC, immunohistochemistry; IRC, independent review committee; IRF, independent review facility; ITT, intent-to-treat; IV, intravenous; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PDC: platinum-based doublet chemotherapy; PD-L1, programmed death ligand 1; PFS, progression-free survival; PO, taken orally; Q3W, every 3 weeks; Q4W, every 4 weeks; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; sCRT: sequential chemoradiotherapy; TC, tumor cells; TKI, tyrosine kinase inhibitor; UICC, Union for International Cancer Control.


1. Peters S, et al. N Engl J Med 2017;377:819–838. 2. Peters S, et al. Ann Oncol Epub 2025:1–12. 3. Hida T, et al. Lancet 2017;390:29-39. 4. Nakagawa K, et al. Lung Cancer 2020;139:195–199. 5. Novello S, et al. Annals Oncol 2018;29:1409–1416. 6. Wolf J, et al. ESMO Open 2022;7:100333. 7. Zhou C, et al. Lancet Respir Med 2019;7:437–446. 8. Zhou C, et al. JTO Clin Res Rep 2024;5:100700. 9. Wu YL, et al. N Engl J Med 2024;390:1265–1276. 10. Dziadziuszko R, et al. J Thorac Oncol 2021;16:2040–2050. 11. Gadgeel SM, et al. Ann Oncol 2023;34:S782–S783. 12. Popat S, et al. HORIZON-01: a Phase 1-111 platform study evaluating the efficacy and safety of multiple therapies in patients with biomarker-defined locally advanced, unresectable stage Ill non-small cell lung cancer (NSCLC). Presented at: BTOG; 2025 March 3–5. Belfast, Ireland.

 

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