Trial-by-gene · ALK

Active clinical trials enrolling ALK fusion-positive NSCLC

Decision-support aid only — eligibility decisions must be confirmed against the actual trial protocol and the patient's medical record. Trial counts and statuses change daily; this page is for orientation, not adjudication.

ALK-fusion NSCLC has multiple FDA-approved TKIs and continues to generate post-lorlatinib resistance trials, next-generation pan-ALK inhibitors with G1202R coverage, CNS-active regimens, and adjuvant settings for resected ALK-positive disease.

See the ALK cheat sheet.

Browse the live listing

Search ClinicalTrials.gov for actively recruiting NSCLC trials with ALK-directed interventions.

Open ClinicalTrials.gov listing

Source: ClinicalTrials.gov, US National Library of Medicine. Trial-listing data is in the public domain. Use of ClinicalTrials.gov data must comply with the NLM terms of use.

Representative trial phases and designs

Phase III, 1L

Lorlatinib vs crizotinib (CROWN long-term follow-up); next-gen 1L candidates.

Phase II, post-lorlatinib

Next-generation ALK inhibitors (NVL-655 and similar) covering compound resistance mutations.

Phase III, adjuvant

Alectinib adjuvant in resected stage IB-IIIA ALK+ NSCLC (ALINA already FDA-approved 2024).

Frequently asked questions

Are post-lorlatinib trials only for resistance after 1L lorlatinib?
Most accept any prior ALK TKI exposure with documented progression; some require lorlatinib specifically for the compound-mutation hypothesis.

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