A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC (NCT03202940)

🧪 Interventions in This Study

• Alectinib (DRUG)
• Cobimetinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Ability to understand and the willingness to sign a written informed consent document.
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in-situ hybridization (FISH) test, using Vysis® ALK Break apart FISH Probe, or the Ventana® immunohistochemistry (IHC) test. Diagnosis using next generation sequencing (NGS) via a local diagnostic test will be accepted for enrollment but will need to be confirmed with either FISH or IHC.
4. For the expansion cohort: Patients must have had disease progression on alectinib (including patients who received alectinib as first-line treatment). Subsequent anti-neoplastic therapy (including other ALK inhibitors or chemotherapy) after progression on alectinib is not permitted. Note: patients in the dose-finding portion of the study may have received other anti-neoplastic therapy after progression on alectinib.
5. At least one measurable lesion as defined by RECIST version 1.1. Previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation.
6. Eastern Cooperative Group (ECOG) performance status ≤ 2 for patients treated in the expansion phase. ECOG PS ≤ 1 is required for participants in the dose-finding portion of the study.
7. Life expectancy of greater than 12 weeks
8. Patient willingness and disease accessible to pre-treatment, on-treatment tumor, and progression biopsies (core biopsies). A cell block from a pleural effusion may be substituted for a core biopsy.
9. Able to swallow and retain orally administered medication. Does not have any clinically significant gastrointestinal abnormalities, such as malabsorption syndrome or major resection of the stomach or small bowel that may alter absorption of the medication.
10. For participants in the dose-finding phase, a minimum washout period of at least 5 half-lives between the last dose of tyrosine kinase inhibitor (TKI) therapy and the first dose of study treatment is required. For patients on crizotinib, a 7 day washout is sufficient. A shorter washout period may be considered in the event of disease flare, after discussion with the Sponsor. No washout is required if the most recent anti-neoplastic therapy is alectinib.
11. Patients must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels except for adverse events (AEs) that in the investigator's judgment do not constitute a safety risk for the patient.
12. Patients can either be chemotherapy-naive or have received platinum-based chemotherapy for locally advanced or metastatic disease. Acute effects of therapy must have resolved to baseline severity or to CTCAE grade ≤1 except for AEs that in the investigator's judgment do not constitute a safety risk for the patient. Patients who have received prior treatment with checkpoint inhibitors are eligible.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Massachusetts general Hospital — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.