How many clinical trials are studying Alectinib?

6 recruiting trials in our tracked data involve Alectinib.

What conditions is Alectinib being studied for?

In our tracked recruiting trials, Alectinib is being studied in trials for Lung Cancer, Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase Gene Mutation.

Alectinib: clinical trials recruiting now

Q: Is Alectinib FDA-approved?

Yes. According to the FDA drug label available through openFDA, Alectinib is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Alectinib appears in the FDA drug-label database. Marketed as ALECENSA.

FDA-approved use

ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test [see Dosage & Administration (2.1) ]. 1.2 Treatment of Metastatic ALK-Positive NSCLC ALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test [see Dosage & Administration (2.1) ] .

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 2 Phase 3 1 Phase 4 1 Not applicable 2

Conditions being studied

Condition	Trials
Lung Cancer · Alectinib for Lung Cancer	5
Carcinoma, Non-Small-Cell Lung	2
Anaplastic Lymphoma Kinase Gene Mutation	1
Anaplastic Lymphoma Kinase Gene Translocation	1
Anaplastic Lymphoma Kinase-positive	1
Brain Metastases	1
Colorectal cancer	1
Drug Monitoring	1
Erectile Dysfunction	1
Hypogonadism, Male	1
Metastatic Colorectal Cancer	1
NSCLC	1
NSCLC Stage IV	1
Non-small Cell Lung Cancer	1
Sex Disorder	1

Recruiting trials involving Alectinib

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
NCT05525338 · Phase: Phase 4 · Ages: 18 Years and older · Sex: All (male and female) · 8 locations
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
NCT05987644 · Phase: Phase 1, Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 3 locations
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
NCT06532149 · Phase: Not specified · Ages: 18 Years to 75 Years · Sex: Male · 1 location
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
NCT06765109 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 158 locations
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
NCT06862869 · Phase: Not specified · Ages: 18 Years and older · Sex: All (male and female) · 44 locations
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
NCT05725200 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Alectinib FDA-approved?

Yes, marketed as ALECENSA.

How many recruiting trials involve Alectinib?

6 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.