Table of Contents

• Trial overview
• Who is being studied
• Trial phases and designs
• What the trials measure
• Key trials in lung cancer
• Other cancer studies
• Patient-friendly terms

Trial overview

These studies investigate Alectinib in different cancer settings, with the strongest focus on ALK-positive non-small cell lung cancer.^{[2][4][5][6][7][8][9][10]} The trial data also include studies in pediatric ALK fusion-positive tumors, colorectal cancer, and broader advanced cancer groups.^{[1][3][9][11]}

Who is being studied

Some trials include adults with advanced or resectable lung cancer, such as Stage II, IIIA, selected IIIB, Stage III, or completely resected Stage Ib to IIIa disease.^{[2][5][6][8][10]} One study is for pediatric participants with ALK fusion-positive extracranial solid tumors or primary CNS tumors that have progressed after prior treatment or have no satisfactory treatment option.^[4] Other trials include patients with advanced malignancies, biomarker-positive solid tumors, or advanced cancer selected by a molecular tumor profile.^[1][3][9]

Trial phases and designs

The studies are mainly Phase 1, Phase 2, and Phase 3 interventional trials, which means the researchers are actively giving treatments and measuring outcomes.^{[1][2][3][4][5][6][7][8][9][10][9][11]} Phase 1 pediatric research looks at safety, dose-limiting toxicities, and drug levels in the blood.^[4] Phase 2 and Phase 3 studies more often compare treatment benefit, such as response rates, survival outcomes, or pathologic response after surgery.^{[2][5][6][8][10]}

What the trials measure

Common endpoints include objective response rate, which counts confirmed complete or partial tumor shrinkage, and progression-free survival, which measures how long the cancer does not get worse.^{[1][2][5][6][8][10]} Other outcomes include disease-free survival, major pathologic response, pathologic complete response, and disease control rate at a fixed time point.^{[5][6][7][9][9]} Safety is also important, with studies tracking adverse events, serious adverse events, and dose-limiting toxicities.^[2][4][7][9]

Key trials in lung cancer

Several trials focus on ALK-positive NSCLC, where Alectinib is used alone, compared with another drug, or combined with chemotherapy.^{[2][5][6][8][10]} One Phase 3 study compares Alectinib with platinum-based chemotherapy after complete surgery, using disease-free survival as the main endpoint.^[5] Another Phase 3 study compares Alectinib with crizotinib in treatment-naive advanced ALK-positive NSCLC, using investigator-assessed progression-free survival.^[10]

A separate Phase 3 study looks at biomarker-selected, locally advanced unresectable Stage III NSCLC after chemoradiotherapy and measures progression-free survival by blinded independent central review.^[6] The ADAPT ALEC study compares standard fixed dosing with blood-level-adjusted dosing and looks for better progression-free survival in patients whose Alectinib blood level is below a set threshold.^[7] The ALNEO study is a Phase 2 neoadjuvant trial, meaning Alectinib is given before surgery, and the main endpoint is major pathologic response in resected tissue.^[8]

One Phase 2 study in completely resected Stage II, IIIA, and selected IIIB ALK-positive NSCLC explores safety of Alectinib with chemotherapy after early closure of the study.^[2] Another Phase 2 study in locally advanced or metastatic ALK-positive NSCLC compares first-line therapy with other second-generation targeted drugs and measures progression-free survival using RECIST v1.1, a standard scan-based system for tumor measurement.^[9]

Other cancer studies

Not all trials are limited to lung cancer. One Phase 1 pediatric study examines safety, tolerability, pharmacokinetics, and anti-cancer activity in ALK fusion-positive solid or central nervous system tumors.^[4] The DRUP trial is a large Phase 2 precision medicine study that includes Alectinib among many targeted drugs for patients with advanced cancers that have matching genomic or protein changes.^[3]

The EVIDENT study in colorectal cancer uses tumor biopsy and pharmacogenomic profiling to match patients to treatment suggested by a molecular tumor board, and it measures objective response rate in the total group and by drug cohort.^[1] FINPROVE is another Phase 2 access study for patients with advanced cancer, and its main goal is disease control at 16 weeks after treatment starts.^[9] The IMBRELLA B extension study includes Alectinib as one of several treatments available to patients who were already enrolled in parent studies and still need ongoing access to therapy.^[11]

Patient-friendly terms

Interventional study means the researchers give a treatment and watch what happens.^{[1][2][3][4][5][6][7][8][9][10][9][11]} Biomarker-selected means patients are chosen because their tumor has a specific feature that may affect treatment choice.^[6][9] Neoadjuvant treatment is given before surgery, while adjuvant treatment is given after surgery to help lower the chance of cancer coming back.^[5][8] Pharmacokinetics means how the body handles the drug, including blood levels over time.^[4]