Study Sponsor: AbbVie Inc.

Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center

Phase of Study: Phase II

Purpose of study: The purpose of the study is to determine the safety and optimal dose of the study drug Telisotuzumab Adizutecan (ABBV-400) as a treatment option for patients with non-small cell lung cancer that have an EGFR mutation. The study drug works by attaching itself to a specific protein which is found in large quantities in cancer cells. After it attaches to the targeted protein, the drug then releases the cell-killing portion into the cancer cells.

Inclusion Criteria

– Must be at least 18 years or older.

– Must be willing to comply with the study visit schedule and procedures that are required for the study.

– Must have confirmed non-small cell lung cancer with documented EGFR deletion or mutation as determined by genetic testing.

– Must be able and willing to provide archival or fresh tissue during screening.

– Must have an ECOG of 0 – 1.

– Must have adequate organ function as determined by local lab tests.

– Must have received at least 1 prior EGFR therapy as single drug or in combination with other drugs, and experienced progressive disease. Some additional criteria regarding specific drug combinations may need to be discussed in further detail with the treating physician and the research team.

– Subject must be an appropriate candidate for platinum chemo based on physician opinion (this applies to the Phase 3 part of the study only).

– Must have at least 1 measurable lesion per RECIST 1.1.

– Any side effects from prior treatments must have resolved to baseline (Hair loss is an exception).

– Documented negative for Hepatitis B or C, (some exceptions may apply based on certain criteria and can be discussed with the physician to check if patient can qualify). May need to agree to monitoring while on study if the patient had a previously resolved infection.

– HIV-positive patients may enroll provided they meet specific criteria.

– Female subjects of childbearing potential must have negative serum pregnancy test at screening, and negative urine pregnancy on Cycle 1 Day 1 prior to receiving the study drug. Additionally, must not breastfeed, must not be currently pregnant, and must not donate eggs while on study and for 250 days following the last dose of the study drug administered. Must also agree to at least 1 form of highly effective contraception while on study.

– Male subjects must agree to effective contraceptive methods from Cycle 1 day 1 through 160 days after the last of study drug, and must also agree not to donate sperm while on study and through the same time frame (160d).

Additional criteria may apply and will be discussed with the treating physician and research team.

Exclusion Criteria:

– Subject’s tumor(s) has/have adenosquamous or squamous histology, or sarcomatoid features.

– Subject has known small cell transformation.

– History of ILD or pneumonitis that required treatment with steroids, or any evidence of active pneumonitis/ILD on screening chest CT.

– History of significant lung-specific illness such as COPD, severe asthma, pulmonary emboli within 3 months, dependent on supplemental oxygen, etc.

– Known symptomatic brain metastases or carcinomatous meningitis. Subjects with previously treated brain mets may be eligible provided they are stable (without evidence of progression per MRI) for at least 4 weeks prior to first dose. Some additional criteria may apply, and should be discussed with the physician and research team.

– Has leptomeningeal disease or spinal cord compression that has not been treated with surgery or radiation.

– Has history of any other malignancy (some exceptions may apply, such as successfully treated nonmelanoma skin cancer, or local carcinoma in situ of the cervix).

– Any significant medical conditions that, in the opinion of the physician, would interfere with the patient’s ability to take part in the study.

– Has an active or chronic infection that requires treatment and has not resolved within 14 days prior to randomization.

– Has a significant cardiac condition or disease (specifics to be discussed with the physician).

– Has had a major surgery within 28 days prior to cycle 1 day 1 of treatment (a biopsy is allowed for study purposes).

– Is pregnant/breastfeeding or expecting to conceive while on study.

– Received another study drug within 28 days prior to first dose.

– Received a live vaccine within 14 days prior to first dose.

– Is suffering from substance abuse issues within 6 months.

– Was previously enrolled in a Telisotuzumab Adizutecan trial.

Additional criteria may apply and will be discussed with the treating physician and research team.

Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com  

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