A Single-Arm Phase 2 Study of Daratumumab Subcutaneous (SC) in Previously Treated STK11/LKB1 Mutated Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-arm study of daratumumab in metastatic non-small cell lung cancer (NSCLC) patients with an STK11/LKB1 mutation. Patients will have received previous standard of care treatment including chemotherapy, immunotherapy and targeted therapy. Patients will be treated with the standard subcutaneous dosing of daratumumab (weekly for 8 administrations, then every 2 weeks for 8 administrations then every 4 weeks until progression). All follow-up visits and imaging will be performed as per standard of care. This is a signal finding study and an overall response rate ≥20% is considered clinically meaningful.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Participant must be ≥ 18 years of age and satisfy the legal age of consent in the jurisdiction in which the study is being conducted.

• Participant must have histologically or cytologically confirmed NSCLC that is metastatic or unresectable.

• Participants must have either progressed after prior immunotherapy with a PD-(L)1 inhibitor, platinum doublet chemotherapy and standard of care targeted therapy (if presence of an activating mutation is identified) for metastatic disease, be ineligible for, or have refused all therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records.

• Participants must have previously identified STK11/LKB1 mutation (identified locally in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory \[or equivalent\])

• Participant must have organ and bone marrow function as follows:

‣ Hemoglobin ≥9 g/dL

⁃ Absolute blood neutrophil count (ANC) ≥1.5 x 109 /L

⁃ Platelets ≥75 x 109 /L

⁃ Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x upper limit of normal (ULN)

⁃ Total bilirubin =1.5 x ULN; participants with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits.

⁃ Serum creatinine \<1.5 x ULN or if available, calculated or measured creatinine clearance; \>50 mL/min/1.73 m2

• Before enrollment, a woman must be either:

‣ Not of childbearing potential: postmenopausal (\>45 years of age with amenorrhea for at least 12 months); permanently sterilized (eg, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy,

⁃ Of childbearing potential and practicing a highly effective method(s) of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, described as follows: practicing true abstinence (when this is in line with the preferred and usual lifestyle of the participant), which is defined as refraining from heterosexual intercourse during the entire period of the study, including up to 6 months after the last dose of study drug is given; OR have a sole partner who is vasectomized; OR practicing 2 methods of contraception, including one highly effective method (ie, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device \[IUD\] or intrauterine system \[IUS\]), AND, a second method, (eg, condom with spermicidal foam/gel/film/cream/suppository or occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/cream/suppository).

⁃ Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active, postmenopausal woman experiences menarche) the woman must begin a highly effective method of birth control, as described above.

• A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin \[β-hCG\]) at Screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug.

• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug.

• A man who is sexually active with a woman of childbearing potential must agree to use a condom and his partner must also be practicing a highly effective method of contraception (ie.. established use of oral, injected or implanted hormonal methods of contraception; placement of an IUD or IUS). If the participant is vasectomized, he must still use a condom, but his female partner is not required to use contraception. The participant must also not donate sperm during the study and for 6 months after receiving the last dose of study drug.

• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, including the agreement by both male and female participants to continue contraception throughout the study and through 6 months after the last dose of study drug.

• Each participant must sign an informed consent form (ICF) indicating that he or she understands the study's purpose and the procedures required for the study and is willing to participate in the study, including the requirement to provide information during the Follow-up period.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Salman Punekar
salman.punekar@nyulangone.org
212 731 6228
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 14
Treatments
Experimental: Patients with STK11/LKB1-Mutated NSCLC
Participants will receive daratumumab 1800mg and hyaluronidase 30,000 units (combined product DARZALEX Faspro) administered subcutaneously per the following dosing schedule:~* Once per week for 8 administrations (Week 1-8)~* Once every two weeks for 8 administrations (Week 9-16)~* Once every 4 weeks until disease progression or unacceptable toxicity.
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov

Similar Clinical Trials